The relaxation intervention was a 30-minute, therapist-led group with relaxation and visualization therapy (RVT) consisting of relaxation, guided imagery, progressive muscle relaxation, meditation, and deep breathing. Each group had up to four patients. The intervention was delivered daily for 24 treatments immediately following radiation treatments. Patients self-administered the treatment at home using audiotapes twice per day. Patients received telephone calls to remind them to perform the intervention at home. Measures of psychological, endocrine, and immunologic data were collected at baseline and after the 24-day intervention.

The study reported on a sample of 34 women with breast cancer receiving radiation treatments (intervention group = 20; control group = 14).

A randomized controlled trial design was used.

• Inventory of Stress Symptoms–Lipp for adults (ISSL)
• State-Trait Anxiety Inventory (STAI)
• Beck Anxiety Inventory (BAI)
• Beck Depression Inventory (BDI)

Analyses were controlled for basal anxiety levels (trait anxiety). The psychological scores did not change over time in the control group, but the experimental group showed significantly reduced levels of stress, anxiety, and depression scores following the 24-day RVT treatment (all p < 0.05). Experimental and control groups showed similar stress and depression scores at baseline. Patients in the experimental group were more anxious than patients in the control group at baseline.

While no biologic changes were noted with RVT, there were significant improvements in psychological functioning with RVT.

The study had small sample sizes.

To evaluate the effectiveness of sucralfate mouthwash in preventing 5-fluorouacil (5-FU) -induced oral mucositis (OM)

Patients were block randomized to receive sucralfate or an identical-appearing placebo. They were instructed to swish 10 ml of mouthwash for 2 minutes and then swallow it. The mouthwash was to be used four times per day starting on day 1 of radiation therapy (RT) and continuing until day 15.

Patients received throat swabs at the beginning of treatment to exclude infection. All patients used cryotherapy and the same salvage treatment (xylocaine topical, acetaminophen/codeine, then morphine sulfate if needed).

Patients were given 1 liter of study drug, and compliance was assessed by the volume left over after day 15. Research nurses contacted each patient by telephone after one week to assess compliance with the mouthwash and complete questionnaires.

• The study reported on 81 patients with colorectal cancer receiving 5-FU and leucovorin for one cycle; 42 patients were in the sucralfate group and 40 were in the placebo group.)
• The median age of patients was 61 years.

This was a randomized, double-blind, placebo-controlled trial.

Patients graded the severity of mucositis at the same time each day (in the evening) for 15 days using a 0–4 rating scale developed by the North Central Cancer Treatment Group. In addition, 1–6 analgesic diaries, the McGill Pain Questionnaire, and a 0–10 quality of life measurement tool were used on follow-up visits.

No significant differences were found between the two groups in terms of the following measures.

• Sum of daily mucositis score (p = 0.86)
• Daily pain score (p = 0.90)
• Eating difficulty (p = 1.00)
• QOL (p = 0.57)
• Duration of mucositis (p = 0.74)
• Number of analgesics (p = 0.19)

More women experienced mucositis than men.

The patient and medical assessments differed, and the authors stated that patient reporting is believed to be more sensitive.

The study did not conclude that sucralfate was an effective solution for the prevention of oral mucositis in this study population.

• The trial was closed early because the placebo expired.
• The trial did not meet patient accrual numbers.
• Medical staff underestimated mucositis incidence.
• The study lacked statistical power.
• No daily assessment was done.
• The placebo mouthwash was not described.

To provide a meta-analysis that examines interventions delivered to family caregivers of patients with cancer in published randomized controlled trials and their effects on multiple caregiver outcomes

• Databases used in the search were CINAHL, Google Scholar, ISI Web of Knowledge, PsycINFO, and PubMed.
• Keywords were family caregiver, cancer patient, spouse, partner, couple, and interventions used in various combinations. In cases where the query resulted in more than 200 titles, additional refinement was done with use of “random assignment” and “randomization.”
• Hand searches of reference lists of related literature reviews were used to complement computer searches. Limits of English language and involving human subjects were used.
• To be included, (a) the intervention had to involve family caregivers alone or with a patient with cancer, (b) the intervention had to be psychosocially, cognitively, or behaviorally oriented, and (c) participants had to be randomly assigned to either an intervention or control arm of the study.
• Studies involving pediatric patients with cancer and pharmacologic interventions were excluded.

• Initial queries provided 403 articles, in which 160 were potentially relevant. Of these, 124 were excluded as per criteria and 7 were excluded because caregiver outcome data were not reported.
• At least two members of the research team read and analyzed each article. Data were extracted using a standard table, and disagreements were resolved through consensus. Data extracted were organized into three domains: illness appraisal factors, coping resources, and quality of life (QOL).
• Effect sizes were calculated using outcome data from the experimental arm hypothesized by the original researchers to be most effective, in those studies that had more than one experimental arm.
• Extracted data were organized into three time frames: baseline to three months postintervention (T1), follow-up from > three months to six months (T2), and follow-up beyond six months (T3).

The final sample of studies used in the meta-analysis was 29, including a total of 3,495 subjects across all studies.

Intervention Types

• 57.1% of interventions were psychoeducational in which the primary focus was to provide information regarding symptom management and physical aspects of care, as well as to direct some attention to emotional and psychosocial needs of patients, caregivers, and marital and family relationship.
• 25.7% of protocols were focused on skills training: development of coping, communication, and problem-solving skills.
• 17.1% of interventions were therapeutic counseling, focusing primarily on development of a therapeutic relationship to address concerns.
• The most common combination of primary and secondary interventions included both psychoeducational and skills training (68.6%).

Appraisal Domain Results

• Eleven studies assessed caregiving burden during the first three months. Effect sizes ranged from -0.12 to 0.62, with a small but significant effect size (g = 0.22).
• In two studies, interventions had a positive significant effect on appraisal of caregiving benefit between three and six months (g = 0.31). Beyond six months, this appraisal showed a larger effect size, but was not significant. (Caregiving benefit was seen as a rewarding experience and opportunity for personal growth.)
• Three studies looked at whether the intervention was effective in addressing caregivers’ information needs. Overall effect size was large and significant (g = 1.36, range = 0.85–1.87).

Coping Resources Domain

• Coping efforts were evaluated during the first three months in 10 studies. After the intervention, overall effect size was moderate but significant (g = 0.47, range = -0.47–1.46).
• In four studies, changes in coping efforts three to six months postintervention showed a smaller but significant effect size (g = 0.20).
• Two studies evaluated coping efforts beyond six months. There was a persistent moderate effect that was significant (g = 0.35).
• In eight studies that evaluated self-efficacy within three months postintervention, overall effect size was small but significant (g = 0.25, range =  -0.13–0.93). This positive significant effect persisted over time.

Quality of Life Domain

• In seven studies that evaluated physical functioning, during the first three months overall effect size was small and not significant. However, interventions were superior to usual care in improving physical functions at three to six months (g = 0.22) and beyond six months (g = 0.26).
• Interventions were seen to be superior to usual care in reducing distress and anxiety, and the effect appeared to last for at least 12 months. Sixteen studies evaluated changes in mental distress and anxiety during the first three months, 11 evaluated these changes at three to six months, and 6 evaluated distress and anxiety beyond six months.
• Interventions were not successful in reducing caregivers’ depression. In all of the studies that evaluated these changes at various time points, overall effects were small and not significant.
• Among 10 studies that evaluated changes in marital and family relationships in the first three months, overall effect size was small but significant (g = 0.20, range = -0.18–0.47). Evaluation beyond three months did not show significant effects.
• Effects on social functions in two studies that were evaluated beyond six months showed an overall positive moderate effect that was significant (g = 0.39). There were no other significant effects seen in other studies that evaluated changes in social functioning.

Effect of Intervention Characteristics

• Coping was found to be significantly influenced by the use of face-to-face and group methods of intervention delivery than those using mixed methods to deliver the intervention.
• Intervention hours and number of sessions were significantly positively correlated with coping outcomes.
• More sessions were associated with more negative (worse) outcomes in the case of caregiver burden, depression, and marital-family relations.
• Interventions that included caregivers alone reported significantly better outcomes in appraisal of caregiving benefit than interventions that also included patients.

Nurses participated in delivery of the intervention in about half of the studies examined. Interventions focused on three broad areas: patient caregiving, marital/family care, and caregiver care, although there was considerable variability in the emphasis of each area in all studies and many interventions focused mostly on the patient, with a peripheral addressing of caregiver needs. The meta-analysis noted there is a consensus that these are essential content for caregiver-focused intervention protocols. Many of the 29 studies used theoretical models to structure their protocols and had plans to assess integrity of the interventions. Interventions were found to not be effective in decreasing caregiver depression, perhaps a result of the type of cancer or high predominance of females in the 29 studies. On the other hand, interventions aimed at improving caregiver coping were more effective, particularly if the intervention included more sessions and lasted a longer time. Coping outcomes improved more often with face-to-face or group-delivered interventions and if the focus was on promoting active caregiver coping and reducing avoidance and denial behaviors. Although the meta-analysis showed a large intervention effect with decreasing caregivers’ need for knowledge (and most studies had a significant educational component), few studies measured caregiver change in knowledge as an outcome.

This meta-analysis of 29 studies, with variant use of theoretical models, offers insight into effective interventions that improve the life of cancer caregivers and those for whom they care for. Despite the diversity in interventions found in the studies, caregivers reported better outcomes in illness appraisal, coping resources, and quality of life following research study involvement. Positive and long-term intervention effects occurred for caregiver coping, self-efficacy, and distress/anxiety outcomes across all studies. Continued emphasis must be placed on weaving theoretical models throughout studies to generate hypotheses, select components of intervention to ensure integrity, and identify outcomes.

To test the effects and feasibility of a tailored web-based, nurse-delivered psychoeducational intervention on patient and caregiver outcomes

Patients and caregivers were given unique access to web-based questionnaires and completed these separately. The web-based program consisted of three sessions two weeks apart to provide education sequentially, including cancer effects on family, family strength and value of teamwork, family concerns, addressing problems, communication tips, types of support, finding meaning in illness, and looking to the future. Dyads completed sessions together and were offered choices of tailored activities to promote interaction between web sessions. Dyads also received tailored messages according to baseline score in areas such as communication, support, and self-efficacy. Follow-up email session reviews were done after each web session. The study was conducted over eight weeks. Study measures were obtained at baseline and week 8.

• N = 38 dyads  
• MEAN AGE = 54.8 years for patients, 50.6 years for partners
• MALES: 39.5% of caregivers, FEMALES: 60.5% of caregivers
• KEY DISEASE CHARACTERISTICS: Breast, colorectal, lung, and prostate cancers; 47.4% had stage I or II disease, and the rest had stage II or IV.  
• OTHER KEY SAMPLE CHARACTERISTICS: 5.3% were African American, and 2.6% were Asian—the rest were Caucasian. More than 80% had at least some college education, and  more than 60% had annual incomes of $50,000 or more.

• SITE: Single site  
• SETTING TYPE: Home  
• LOCATION: United States

• Quasi-experimental

• FACT- G version 4 for quality of life
• Satisfaction with the program 
• Benefits of illness scale
• Lewis Mutuality and Interpersonal Sensitivity Scale 
• Social Support Scale 
• Lewis Cancer Self-Efficacy Scale

Dyads had decreased overall emotional distress (p < .05), anger-hostility (p < .01), and fatigue-inertia (p < .05), and improvement in overall quality of life (p < .05), physical quality of life (p < .05), functional quality of life (p < .01), and perceived benefits of illness or caregiving (p < .01). Effect sizes for caregivers were medium for self-efficacy (d = .40) and social support (d = .33), although changes from baseline were not statistically significant. Small effect sizes were seen for emotional and fatigue outcomes. Significant change over time was seen for total emotional distress, anger-hostility, fatigue inertia, and total quality of life for dyads together. Patients improved in the areas of physical quality of life, and caregivers improved in the area of self-efficacy. The web-based program had an 86% retention rate.

Findings show that this type of web-based program is feasible and may benefit patients and caregivers.

• Small sample (less than 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias(sample characteristics)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: The sample was generally well educated and had a higher-level income, so findings may not be generalizable to other groups. The intervention would only apply to those with internet access and some level of comfort with computer use. What phase of care all patients were in, or if any were receiving treatment, is not clear. If participants had any other supportive services involved in their care is not clear.

Findings suggest that provision of a tailored, web-based psychoeducational and messaging intervention is feasible and may improve some patient and caregiver outcomes. A web-based approach for this type of intervention can provide a practical alternative for patients with ability to use the internet. Additional well-designed studies in more diverse patient groups will be helpful to further demonstrate efficacy and usability.

To determine if patients with advanced breast cancer and their family caregivers involved in a family-focused intervention report better appraisal, coping, and quality of life and less uncertainty and hopelessness than do similar people involved in standard care only

Dyads (patient/primary family caregiver) were assessed at baseline and stratified according to type of current treatment and number of breast cancer recurrences and then randomized into a usual care group or experimental group (usual care plus FOCUS program). The FOCUS (family involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom management) program was a family-focused information and support intervention of about 1.5 hours on three occasions scheduled one month apart. Intervention boosters occurred via prearranged follow-up 30-minute telephone conversations with both patients and caregivers led by the same nurse. Dyads completed assessments at baseline, three months after the home visits, and six month following phone conversations.

• The sample included 134 patient/caregiver dyads.   
• Mean caregiver age was 52 years (range = 18–87 years); mean patient age was 54 years.
• The sample was 62% male and 13%+ female (some patient caregivers were daughters, siblings, or friends; later two groups were not identified by gender).
• Patients had a confirmed diagnosis of recurrent breast cancer within the past month/had a disease-free interval at the time. More than half had history of mastectomy, family history of breast cancer, and node involvement with surgery; more than half had experienced their first recurrence of breast cancer; and more than half were receiving chemotherapy or a combination of methods to treat the cancer.
• Of the dyads, 77% were Caucasian and had completed an average education level of 14 years, with median annual family income of $30,000–$50,000.

• Multisite  
• Home setting
• Midwestern United States

Active antitumor treatment phase

A prospective, longitudinal, randomized clinical trial design was used.

• Omega Screening Questionnaire (OSQ) (reliability and validity established earlier)
• Appraisal of Illness Scale
• Appraisal of Caregiving Scale
• Mishel Uncertainty in Illness Scale
• Beck Hopelessness Scale
• Brief COPE
• Functional Assessment of Cancer Therapy (FACT) Scale (version 3, FACT-B, FACT-G)
• Short Form–36 (citations provided affirm all instruments with adequate psychometric properties, current study validated psychometrics)
• Karnofsky  Performance Status Scale
• Patient medical records

Patients who received the FOCUS program reported a significant decrease in negative appraisal of illness from baseline to three months (p < 0.008), while patients who received usual care did not. However, at six months, the FOCUS and usual care groups had similar scores on this dimension. FOCUS group patients significantly decreased their hopelessness score from baseline (p < 0.03), but the usual care group significantly increased their hopelessness score (p < 0.03). At six months postintervention, no significant difference in hopelessness scores existed between groups. FOCUS group caregivers showed a similar significant (p < 0.004) decrease in negative appraisal of illness while the usual care caregivers did not. However, this difference was not sustained at six months. No changes in quality-of-life measures were found over time between usual care and FOCUS group participants (patients and caregivers).

The FOCUS program assisted patients with recurrent breast cancer to report less hopelessness following the initial intervention, and both FOCUS patients and their caregivers reported less negative appraisal of illness; however, intervention effects were not apparent over time. The intervention did not show an effect on caregiver quality-of-life measures.

• The study had baseline sample/group differences of import.
• Risk of bias existed due to no blinding, no appropriate attentional control condition, and sample characteristics.*
• Key sample group differences could have influenced results.*
• Subject withdrawals were ≥ 10%.
• Other limitations/*explanation: There were significant differences between groups in measured hopelessness at baseline.

Study findings suggest that the intervention provided had a short-term effect on improving patient sense of hopelessness. Findings do not support effectiveness of this approach on caregiver quality of life.

To determine (a) whether patient/caregiver dyads randomly assigned to either an extensive or brief dyadic intervention (i.e., FOCUS program) would have better intermediary outcomes (i.e., less negative appraisals and increased resources) and primary outcomes (i.e., improved quality of life) than control patient/caregiver dyads receiving usual care, and (b) whether risk for distress and other antecedent factors (e.g., gender, type of dyadic relationship, cancer type) would moderate the effect of either the brief or extensive program on intermediary and primary outcomes

A stratified randomization process placed participants into groups according to risk status, cancer type, and research site. Participants were then randomly assigned to one of three study arms: control group (usual care), brief FOCUS group, or extensive FOCUS program. The FOCUS intervention was a home-based dyadic intervention used by the authors in previous randomized controlled trial studies and focused on providing support to the patient/caregiver unit. The FOCUS program addressed five content areas: family involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom management. The brief FOCUS program intervention consisted of three contacts (two 90-minute home visits and one 30-minute phone encounter), while the extensive FOCUS program intervention included six contacts (four 90-minute home visits and two 30-minute phone discussions). Both interventions lasted 10 weeks. Trained intervention nurses delivered the home interventions, and attention occurred throughout the study to ensure treatment fidelity (protocol checklist, length of session, randomly tape-recorded sessions). Data were collected by research nurses blinded to dyads’ group assignment at baseline and at three and six months postbaseline for the three groups in the study.    

• The sample was comprised of 484 patient/caregiver dyads.  
• Mean patient age was 60.5 years (SD = 10.9); mean caregiver age was 56.7 years (SD = 12.6).
• Males represented 38.6% of patients and 44.2% of caregivers; females represented 61.4% of patients and 55.8% of caregivers.
• At enrollment, most patients had breast cancer (32%), followed by lung (29%), colorectal (25%), or prostate (13%) cancer.
• Mean years of education for participants was 14.8 years (SD = 2.7).
• The sample was 85.5% Caucasian, and 74% of caregivers were spouses.
• Patients (72%) and caregivers (66%) had comorbid conditions, including hypertension or heart problems; patients’ average length of time since diagnosis was 47 months, and 66%  were receiving chemotherapy; no significant differences existed between the three groups (usual care, brief intervention, and extended intervention) on changes in treatment, progression of disease, demographic or medical variables, or study attrition.
• The study had 62.4% retention.

• Multisite
• Home setting
• Four cancer centers in metropolitan areas of Michigan, Nevada, and Connecticut

• Active treatment phase for advanced cancer
• Late effects and survivorship

A longitudinal, repeated measures randomized controlled trial design was used. 

• Risk for Distress Scale (RDS): To measure demographics, health history, current concerns, and symptom distress; appropriate internal consistency values were collected at three assessment times.   
• Appraisal of Illness Scale (patients) and Appraisal of Caregiving (caregivers): To assess perceptions and appraisal  of cancer experience; appropriate internal consistency values were collected at three data collection times; averaged internal consistency range was 0.89–0.91 over three assessment periods.
• Mishel’s Uncertainty in Illness Scale: To measure the degree of uncertainty experienced during an illness    
• Beck Hopelessness Scale: To measure level of  hopelessness; averaged internal consistency range was 0.84–0.88 over three assessment periods.  
• Brief Cope: To measure active and avoidant coping behaviors; averaged internal consistency range was 0.78–0.88 over three assessment periods. 
• Healthy Behaviors: To assess activities encouraged in the intervention (i.e., healthy diet, exercise); averaged internal consistency range was 0.61–0.67 over three assessment periods.
• Lewis Mutuality and Sensitivity Scale: To assess communication within dyad; averaged internal consistency range was 0.93–0.94 over three assessment periods.
• Lewis Cancer Self-Efficacy Scale: To measure the level of self-efficacy; averaged internal consistency was 0.98 over three assessment periods.
• Social Support Questionnaire: To measure the level of dyadic support; averaged internal consistency range was 0.84–0.87 over three assessment periods.
• Functional Assessment of Cancer Therapy: To assess overall quality of life and four domains: social, emotional, functional, and physical well-being; averaged internal consistency range was 0.75–0.86 over three assessment periods.

Data collection occurred over four years with 62.4% retention for all data assessment points. Significant group by time interactions occurred and showed that the dyads in the FOCUS program (brief and extensive) had significant improvement in coping (p <0.05), self-efficacy(p < 0.05), social quality of life (p < 0.01),  and  caregivers’ emotional quality of life (p < 0.05). Extensive FOCUS program (p = 0.001) and brief FOCUS program (p = 0.033) dyads had decreased avoidant coping at three months, but this only remained in the brief group at six months. Extensive FOCUS program and brief program dyads maintained social quality of life at three and six months. Only brief FOCUS group couples significantly increased their use of healthy behaviors at three months (p = 0.001), but this was not sustained at the six-month assessment. Overall effects varied by intervention dose (extensive versus brief FOCUS program), and most were found only at three months. Risk for distress supported very few moderation effects.

Both brief and extensive FOCUS interventions supported positive dyadic outcomes, but few sustained outcomes were identified at six-month assessment. This study showed a six-week intervention significantly improved dyads’ self-efficacy, but a shorter three-week intervention significantly improved their use of healthy behaviors. Level of risk for distress did not significantly affect or moderate the outcomes of the intervention.

• Only patients’ risk status (high versus low [categorical variable]) was used to stratify patients into groups, thus limiting the sample found for study; using a continuous variable or a dyadic risk score might have produced different findings.
• The study needed to collect information on patients’ functional status over time for more complete interpretation of findings.
• The study had no attentional control.

This study offered insight into a theory-based intervention for advanced and diverse diagnosis of patients with cancer and their caregivers to improve their coping ability, self-efficacy, and quality of life as individuals and as dyads. Too often caregivers are ignored in patient oncology care, yet evidence indicates that the interdependency of patient and caregiver demands nursing interventions that respond to patient and caregiver cancer challenges. With a move toward more interdisciplinary oncology care and measurement of cost-effective and quality interventions, nurses will play an important role in supporting inpatient and outpatient practice environments that implement and evaluate multifaceted interventions known to improve dyadic response to cancer.

To compare efficacy of two dosing schedules of palonosetron for prevention of nausea and vomiting caused by interleukin-2- (IL2) based biochemotherapy

Patients who were treatment naïve were randomized to one of two dosing schedules for 0.25 mg IV palonosetron for prophylaxis of chemotherapy-induced nausea and vomiting (CINV). Schedule one was on days 1 and 4, and schedule two was on days 1, 3, and 5. All patients received the same chemotherapy/biotherapy regimen, which consisted of dacarbazine on day 1; cisplatin, vinblastine, and IL-2 on days 1-4; and interferon (IFN) alpha 2b on days 1–5 as part of a 21-day cycle. Patients also received 0.5–1 mg IV lorazepam every 8 hours. Rescue medications were 50 mg IV metoclopramide with 25 mg IV diphenhydramine every 4 hours, 10 mg IV prochlorperazine every 4 hours, or a combination of lorazepam, diphenhydramine, and haloperidol compounded in hospital pharmacy. An episode of nausea or vomiting was defined as nausea or vomiting of any severity reported by the patient or documented by the nursing staff at any time during the 21-day treatment cycle as well as the need for rescue medication during the first 7 days. Patient diaries were used to document episodes of nausea and vomiting and the antiemetic used to control them. Function Living Index-Emesis (FLIE) was used to assess the patient’s quality of life daily for days 1–7.

• The study reported on 30 patients with a median age of 53.
• The sample was 60% male and 40% female.
• Patients had been diagnosed with stage III–IV metastatic melanoma and had European Cooperative Oncology Group (ECOG) performance statuses of 0–1 and expected survival greater than eight weeks.

This was a single site, inpatient study conducted at the M.D. Anderson Cancer Center in Houston, TX.

Patients were undergoing the active treatment phase of care.

This was a randomized, two-group, comparison study.

• Patients used the FLIE to evaluate quality of life.
• Patient diaries were used to document episodes of nausea and vomiting and use of antiemetics.

Each group (schedule 1 and schedule 2) had 15 patients. For the first 7 days of treatment, more episodes of nausea were reported for schedule 1 than schedule 2, but the difference was not statistically significant (p = 0.16). A similar trend was observed when comparing the number of episodes of emesis during the first 7 days (p = 0.20), the number of antiemetic rescue doses required (p = 0.30), and number of episodes of nausea and emesis during the first 21 days. Evaluation of the FLIE revealed similar proportion of patients on schedule 1 and 2 experiencing interference with appetite, sleep, physical activity, social life, and enjoyment of life (p = 0.071).

Because of the small sample size, differences in dosing schedule efficacy cannot be determined with confidence. However, a trend toward better control of CINV was noted with more frequent palonosetron dosing.

• The sample size was small, with fewer than 100 patients.
• The study was not powered or designed to show statistical differences. The patients in the schedule 1 group had higher prevalence of liver metastasis; while not statistically significant, sample size may not be large enough to determine if this was significant.  

Corticosteroids for the prevention of biochemotherapy-induced nausea and vomiting are contraindicated because they cause lysis of lymphokine-activated killer (LAK) cells produced in response to IL-2, which makes control of CINV challenging. This study does not provide evidence to support use of antiemetic schedule 1 versus schedule 2. More research is needed.

To investigate the influence of parecoxib on morphine analgesia after gynecological tumor surgery

The test group (group P) was given 40 mg IV parecoxib prior to induction of anesthesia and 40 mg IV q 12 hours for 48 hours after the operation. The control group (group C) was given 2 ml saline at the same time intervals. Both groups were introduced to a patient-controlled analgesia (PCA) device and documentation of postoperative pain or adverse effects on Visual Analog Scale (VAS).

• N = 79  
• AGE RANGE = 18–60 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Gynecological tumor
• OTHER KEY SAMPLE CHARACTERISTICS: American Society of Anesthesiologists (ASA) physical status I-II

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: Guangzhou, China

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care, palliative care 

Placebo-controlled, randomized, controlled trial

• Visual Analog Scale (VAS)
• Morphine requirement
• Satisfaction score and side effects
• Sedation scale

There was a reduction of about 9% in the total morphine requirement used within the first 48 hours after gynecological tumor surgery, and overall satisfaction scores were 8.6 versus 6.8 (groups P and C, respectively). Pain scores at rest and with movement were significantly lower in the parecoxib group at all postoperative time points (p < .001).

The use of parecoxib with patient-controlled analgesic morphine in postoperative analgesia resulted in enhanced analgesic efficacy, reducing the opioid requirement, increasing patient satisfaction, and reducing pain severity after gynecological tumor surgery.

• Small sample (< 100)
• Other limitations/explanation: With regard to reporting and assessing side effects, specifically nausea, vomiting, urinary retention, and sedation, the authors reported the differences were clinically insignificant. However, the control group had twice as many reports of nausea, vomiting, and urinary retention in the 48 hours postoperatively compared to the test group (P) as well as a 7% increase in reports of sedation. The study limited itself to the use of PCA morphine only. Additional studies would be of benefit to determine the influence of parecoxib on morphine use (small study size).

This study has positive implications for nursing and healthcare professionals as it did show a 9% decrease in morphine PCA use in the first 48 hours postoperatively with fewer reported side effects. This study should be replicated with a larger sample size to validate its findings.

To evaluate the effects of irsogladine maleate (IM) on fluorouracil-induced oral mucositis

Patients were randomly assigned to irsogladin maleate (IM) or placebo or normal saline. Treatment was administered orally twice a day, 4 mg/day beginning on the first day of chemotherapy and continued for 14 days. Oral rinse with sodium gualenate hydrate, standard care was also used 4 times daily. Other oral treatments were not allowed. Patients were assessed on days 1, 3, 5, 8, 10, 12, 14, 21, and at the end of the chemotherapy cycle.

The sample was comprised of 66 patients. Age in the IM arm: 35-79, in the placebo arm 30-79 .

MALES (%) IM arm n = 20 and placebo arm n = 21; FEMALES (%) IM arm n = 13 and placebo n = 12.

KEY DISEASE CHARACTERISTICS: 83% of all patients had tumors in the head and neck or esophagus.

OTHER KEY SAMPLE CHARACTERISTICS: Most patients had stage III-IV tumors. Chemotherapy included 5FU and cisplatin or nedaplatin.

SITE: Single site

SETTING TYPE: Inpatient

LOCATION: Kansai Medical University, Hirakata, Japan

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Elder care

Double blind randomized placebo controlled

WHO grading of oral mucositis
NCI – CTCAE

Incidence of oral mucositis was 27.3% in the IM group and 72.7% in the placebo group (hazard ratio 0.14, 95% CI 0.05-0.42, p < 0.001). Changes in oral mucositis showed that severity scores were significantly lower in the IM group on multiple study days (p < 0.05). No adverse events related to IM were found.

This study adds to the evidence suggesting that IM is useful in the prevention of oral mucositis.

Small sample (<100)

Key sample group differences that could influence results

Other limitations/*explanation: There is no information regarding patient adherence to the protocol for frequency of medication use.

This study showed that irsogladine maleate use was associated with reduced incidence and severity of oral mucositis in these patients receiving chemotherapy associated with development of mucositis. There are few treatments that have been shown to be effective for mucositis prophylaxis. Given the promising results in this relatively small study, further research is warranted.

To clarify the efficacy of Goshajinkigan (GJG) for peripheral neuropathy associated with oxaliplatin

Intervention Studies: From January 2007 through December 2009, 45 patients with advanced or recurrent colorectal cancer who were being treated with 5-fluorouracil, oxaliplatin, and leucovorin (FOLFOX) every two weeks participated in the study. Patients were randomized to receive either oral GJG (7.5 g/daily) or no drug. The median number of cycles was 13 for the patients in the GJG group and 12 for the control group. Neuropathy was evaluated during every course according to the Neurotoxicity Criteria of Debiopharm. Other neuromodulatory agents such as calcium and magnesium infusions were not allowed during the study. Oxaliplatin dose was reduced in the event of grade 3 neuropathy.

• N = 21      
• MEDIAN AGE = 67 years
• MALES = 51%,  FEMALES = 49%
• KEY DISEASE CHARACTERISTICS: The GJG group included 15 patients with colon cancer and 7 patients with rectal cancer. The control group included 16 patients with colon cancer and 7 patients with rectal cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: 82% had received no previous treatment. The median cumulative dose of oxaliplatin was 1112.5 mg/m², with a range of 340–2720.

• SITE: Single site
• SETTING TYPE: Outpatient
• LOCATION: Tokushima University Hospital in Tokushima, Japan

• PHASE OF CARE: Active treatment
• APPLICATIONS: Late effects and survivorship

Prospective, randomized, controlled trial

Patients were evaluated at baseline and during their every-two-weeks treatment course according to the Neurotoxicity Criteria of Debiopharm.

The incidence of grade 3 peripheral neuropathy in the GJG group was significantly lower than in the control group (p < 0.01, log-rank test). The incidence of grade 3 peripheral neuropathy after 10 courses was 0% in the GJG group and 12% in the control group. After 20 courses, it was 33% in the GJG group and 75% in the control group. The only differences in adverse effects between the two groups were peripheral neuropathy and influence on tumor response.

A randomized, double-blind, placebo-controlled trial would be needed to determine efficacy of this oriental herbal medication. No trials with GJG have been conducted in the United States, so no history exists of it being used as an intervention for chemotherapy-induced peripheral neuropathy. These preliminary findings suggest that further research in use of GJG may be warranted.

• Small sample < 30
• Not placebo-controlled
• Not double-blind
• The Neurotoxicity Criteria of Debiopharm was not described. Several other neurotoxicity scales, even a specific oxaliplatin scale, exist. No explanation was provided for why this scale was chosen.
• Sample characteristics of those randomized are provided; however, characteristics of only those who actually completed the study are not described.
• GJG is an oriental herb and would need further testing to be used in the United States in a clinical trial.

Although it has shown some positive results in reducing neuropathy in a clinical trial in Japan, GJG can not be recommended for treating chemotherapy-induced peripheral neuropathy in the United States until further testing occurs in a large, randomized, double-blind study.