To determine the overall efficacy of psychological interventions, in patients with breast cancer, in regard to the outcome variables of anxiety, depression, and quality of life; to examine the moderating effects of disease stage, treatment type, duration, and orientation on overall treatment efficacy

Databases searched were MEDLINE (1966–January 2004), EMBASE (1980–2004), Cochrane Controlled Trials Register (1985–February 2004), PsycLIT (1973–2004), Biological Abstracts (1990–December 2003), CANCERLIT (1975–October 2002), CINAHL (1982–December 2003), and Health Start (1975–January 2004).

Search keywords were cognitive behavioral therapy, group psychotherapy, relaxation, supportive therapy, visual imagery, anxiety, depression, maladjustment, distress, and quality of life. Authors included no language or publication-status restrictions.

Studies were included if they met all these criteria:

• Were randomized controlled trials (RCTs) that evaluated the efficacy of a psychological or behavioral intervention and were aimed at alleviating psychiatric or psychological morbidity
• Included women participants who had
  • A histologically confirmed diagnosis of breast carcinoma of any stage
  • Undergone surgery
• Included at least two arms: an intervention and a control

Studies examining the efficacy of interventions to assuage surgical distress were ineligible.

• Investigators initially reviewed a total of 36 studies.
• The final number of studies assessed for the analysis was 18: 14 studies assessed anxiety and 14 assessed depression.
• Two reviewers assessed eligible trials and assigned a methodological grade by using the Jadad scale. Trials were pooled under outcome variables (anxiety, depression, and quality of life) to obtain three overall effect sizes, with negative values suggesting a favorable outcome for the treatment condition.
• Also included was an academic textbook, Psychosocial Interventions for Cancer, by Baum and Anderson (2001).
• Eight studies were carried out in facilities in the United States; four, in Canada; one, in England; two, in Australia; and one each in Japan, Italy, and China.
• Eight studies had a score of 5 or greater on the Jadad scale. Ten had a score of less than 5.  The maximum score earned by an assessed study was 7.

• Sample range across studies:
  • Anxiety: 1,278 participants, 692 in treatment group and 586 in control.
  • Depression: 1,324 participants, 713 in treatment group and 611 in control.
• Participant age range was 25–73 years.
• Of participants, 70% were married or in a committed relationship, 32% were Caucasian, 23.7% were Asian, 10.2% were African American, and 28.4% were Hispanic. The race of 28.4% was unidentified.

Depression: Authors reported a clinically moderate-to-strong effect (–1.01, 95% CI –1.48 to –0.54, N = 1,324) and robust finding (95% Cl –0.69 to –0.24) in studies treating patients with high psychological morbidity and methodologically more reliable studies. Short-term interventions compared to long-term interventions (–0.56 versus –0.40) showed a stronger clinical benefit for metastatic patients. Group interventions appeared to be moderately to strongly effective in treating depression in advanced disease (–0.56), compared to early-stage disease (–0.15). Cognitive behavioral interventions (–0.56) may be more effective than supportive expressive therapies (–0.36) for patients with advanced disease.

Anxiety: Most trials were conducted on a prophylactic basis rather than involving highly anxious patients. Findings suggested that a moderate-to-strong clinical impact may be observed in patients with breast cancer who are experiencing clinically significant anxiety. Short-term interventions were associated with clinically moderate effects; longer-term interventions also showed a clinically moderate effect (–0.40) in favor of treatment for patients with metastatic disease but not for those with early-stage breast cancer. Group interventions demonstrated a clinically moderate impact in favor of treatment (–0.40). Patients with more-advanced disease made clinically moderate gains (–0.36) with cognitive behavioral interventions, comparable to the gains made with expressive-supportive therapy (–0.40). Relaxation and guided imagery studies were of lower methodological grade; pure educational interventions failed to show any clinical benefit.

The process of attempting to pool trials and explore effects is complicated and often misleading. Key findings follow.

• In general, interventions targeting patients with clinically diagnosable levels of anxiety or depression are more beneficial than are interventions targeting patients with a lower level of anxiety or depression.
• Group psychotherapy appears to be more effective than individual therapy at treating both anxiety and depression.
• Within a group format, cognitive behavioral interventions appear to be equally effective as supportive-experiential therapies. Duration of treatment need not exceed 20 hours.

Most trials in this analysis relied solely on self-reported measures of anxiety and depression. Literature in the field of cancer indicates that patients with cancer may under-report these symptoms; therefore, self-reported measures may be unreliable and collateral data are needed. In addition, further investigation of the timing of psychological intervention, to determine when the intervention is best delivered, is needed.

To determine the overall efficacy and magnitude of clinical benefit of psychological interventions in patients with breast cancer, specifically looking at three outcome variables: anxiety, depression, and quality of life (QOL)

Databases searched were MEDLINE (1966–January 2004), EMBASE (1980–2004), Cochrane Controlled Trials Register (1985–February 2004), PsycLit (1973–2004), Biological Abstracts (1990–December 2003), CancerLit (1975–October 2002), CINAHL (1982–December 2003), and Health Star (1975–January 2004).

Search keywords were randomized clinical trial and breast cancer and psychological interventions (cognitive behavioral therapy, group psychotherapy, relaxation, supportive therapy, visual imagery) and psychological adjustment (anxiety, depression, maladjustment, distress, quality of life).

Studies were included in the review if they

• Were a randomized clinical trial (RCT)
• Included at least two arms: an intervention arm and a control arm
• Evaluated the efficacy of a psychological/behavioral intervention
• Were aimed at alleviating psychiatric/psychological morbidity, as defined by anxiety, depression, and/or QOL
• Reported on female patients with a histologically confirmed diagnosis of breast carcinoma of any stage who have undergone surgery.

Trials examining efficacy of interventions designed to assuage surgical distress were excluded.

• A total of 383 citations were identified, with 36 potentially relevant articles identified and screened for retrieval.
• The final meta-analysis included 18 RCTs with usable information by outcome.
• Study quality was evaluated using a framework provided by Cook and Campbell (1979) and a quality assessment scale developed and validated by Jadad and colleagues (1996).

Cook, T.D., & Campbell, D.T. (1979). Quasi-experimentation: Design and analysis issues for field settings. Boston, MA: Houghton Mifflin.

• Fourteen trials assessing anxiety were identified, yielding a sample of 1,278 patients.
• Fourteen trials measuring depression were identified, yielding a sample of 1,324 patients.
• Seven trials measuring QOL were identified, yielding a sample of 623 patients.
• Less than half of the trials included were considered to be of high methodological quality.
• Patients’ ages ranged from 25 to 73 years, and approximately 70% were married or in a committed relationship.
• Studies were conducted in the United States, Canada, England, Italy, Australia, Japan, and China.

Anxiety

• Overall effect size (ES) was -0.40 (95% CI, -0.72 to -0.08) in favor of the treatment condition in comparison to the control.
• Sensitivity analyses exploring the impact of methodological quality on overall ES found a reduction in ES associated with higher quality studies, -0.26 (95% CI, -0.42 to -0.10).
• Trials using patients with high morbidity (metastatic breast cancer) yielded a statistically significant overall ES of -0.40.
• Trials whose treatment extended beyond 20 hours had a statistically significant overall ES of -0.30 in favor of treatment.
• Treatment orientation showed differential impact on overall ES with cognitive behavioral therapy (CBT), yielding an ES of -0.11, as well as ESs of -0.40 for guided imagery and relaxation, -0.43 for supportive-expressive therapy, and 0.02 for educational interventions.

Depression

• Overall ES for depression was -1.01 (95% CI, -1.48 to -0.54) in favor of treatment.
• Trials with higher methodological grade were associated with an overall ES of -0.24 in favor of treatment, while lower quality studies had an overall ES of -1.99.
• Studies in which patients had lower morbidity yielded an overall ES of -0.45, whereas those with patients with more advanced disease yielded an overall ES of -1.20.
• Couples and group therapy reached statistical significance with an ES of -1.02 and -1.35, respectively.
• Treatment orientation showed ESs of -0.85 for CBT, -0.55 for guided imagery, -1.80 for supportive expressive therapy, and -0.45 for educational interventions. With the exception of educational interventions, the other subgroup analyses reached statistical significance.

Quality of Life

• Overall ES was 0.74 (95% CI, 0.12 to -1.37) in favor of the treatment group, but this was not statistically significant. When lower quality studies were removed, statistical significance was achieved, but ES was reduced (0.35, p=0.04).

Overall ES trends among the three outcomes show that more reliable studies were associated with smaller gains. Interventions targeted to patients with clinically important levels of anxiety or depression tended to reap the most benefit, compared to patients who undergo treatment on a prophylactic basis. Group psychotherapy appears to be superior to individual therapy in the treatment of both anxiety and depression. However, a direct impact of group therapy on QOL was not supported in this analysis. CBT interventions appeared to be equally as effective as supportive-experiential therapies. Interventions need not span beyond 20 hours to produce statistically significant ES.

The quality of most studies was not high.

Future trials in psychosocial oncology should incorporate methodological features to enhance internal validity. Evaluation of statistically significant findings on psychometric testing may not reflect clinically significant findings and vice versa. This underscores the need for incorporating qualitative analysis in future studies. There is an absence of studies examining the efficacy of short-term interventions on QOL in advanced breast cancer and should be addressed in future research. Short-term, group interventions may provide the best utilization of scarce resources for the most effect; however, they should be targeted to those patients experiencing clinically important levels of distress. Findings point to the need for higher quality research design and reporting in this field.

To evaluate the efficacy of nefopam on acute and chronic postoperative pain from breast surgery

Women were randomized to either nefopam or normal saline placebo control. All patients received 0.05mg/kg of midazolam preoperatively, and all patients received the same anesthetic regimen. At the end of surgery, 30 mg of IV ketorolac was given and, postoperatively, patients were given 0.5 mcg fentanyl if pain rating was 5 or higher. After discharge from PACU, ketorolac was given according to pain ratings, and meloxicam daily was begun as soon as patients started eating. Pain was assessed at 6 and 24 hours postop and at 10 days and at three months.

• N = 83   
• MEAN AGE = 53.2 years
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: All had breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: All were scheduled to undergo lumpectomy.

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: Republic of Korea

• PHASE OF CARE: Active antitumor treatment

• Double-blind, randomized, controlled trial

• Numeric rating scale for pain

Pain scores were significantly lower in the nefopam group immediately after surgery, and at 6 and 24 hours postoperatively (p < 0.01). No differences existed in pain rating at 10 days and three months. Analgesic consumption during the initial postoperative period was also lower in the nefopam group (p = 0.03). Some differences in pain were seen between groups when stratified according to postoperative radiation or nonradiation.

Prophylactic use of nefopam was associated with reduced pain in the first three days postoperatively among women undergoing surgery for breast cancer.

• Small sample (< 100)

Nefopam is a strong central-acting nonopioid analgesic that was shown to be of benefit for management of acute pain. This medication is more commonly used in European countries, and may be a useful alternative to opioids in patients with cancer. Further research is needed to explore its utility for management of various types of cancer-related pain and comparative effectiveness with other common approaches for pain management.

To examine the evidence related to intraspinal analgesia and outline resources required to support patients with cancer-related pain

Databases searched were MEDLINE (1950-2008), EMBASE (1980-2008), CINAHL (1982-2008), and the Cochrane Database. A Google internet search was also performed.

Search keywords were intraspinal, epidural, intrathecal injections, pain, cancer, and study design terms for randomized controlled trials and systematic reviews.

Studies were included in the review if they

• Used a randomized controlled trial (RCT) study design, were systematic reviews of RCTs, or were clinical practice guidelines.
• Involved patients of any age and gender experiencing cancer-related pain.
• Compared intraspinal techniques alone or in combination with different intraspinal techniques or other pain management interventions, compared external versus internal pumps, or evaluated timing of intraspinal techniques.
• Measured pain outcomes with a validated scale.

Studies and reviews were excluded if they

• Used intraspinal techniques for procedure-related pain.
• Were not in the English language.
• Were case reports, letters, comments, or news only.

Three systematic reviews, three consensus conferences, and 12 RCTs met the inclusion criteria for evidence of effectiveness. The Appraisal of Guidelines for Research and Evaluation instrument was used to evaluate guidelines. Indicators to evaluate the quality of the other references were publication status (full versus abstract), statement of statistical power or sample size calculation, intention-to-treat analysis, and statement of sponsorship or funding. The final collection of references were eight practice guidelines (which included four local, internal-use, clinical care algorithms or policy and procedure documents and one practice standard), two systematic reviews, and 12 RCTs. Specific information was provided for two systematic reviews, one consensus statement, and 12 RCTs.

• The studies involved a total of 617 patients with samples ranging from 10–102.
• Ages ranged from 22–82 years.
• Follow-up in RCTs ranged from 18 hours to 169 days.
• Most patients included in RCTs had refractory pain.

• Three studies compared intraspinal pain management to other interventions. Of these, two had small sample sizes and showed no differences. The other study, which involved 202 patients, showed reduced pain on a visual analog scale (p = 0.055) and significant reduction in fatigue and depressed consciousness with intrathecal pain management (p < 0.05). Crossover analysis showed greater clinical success with combined therapy.
• Seven RCTs compared different types of drugs or compared drugs with placebos. Most of these studies had small samples and demonstrated mixed results.
• Two small RCTs compared different intraspinal techniques, including epidural infusion by internal pump, intermittent bolus via porta catheter, and epidural administration of morphine in the thoracic versus cervical regions. No differences in pain outcomes were found. The thoracic route was associated with a greater rate of adverse effects.
• Five documents addressed contraindications for intraspinal analgesia, such as anticoagulation, active systemic or local infection, and neurologic conditions such as unstable central nervous system (CNS) disorders and spinal canal pathology. Unmotivated and noncompliant patients also were identified as contraindicated to this approach.
• Documents addressing care needs discussed equipment types, aftercare, monitoring, hospital discharge, follow-up, interprofessional roles, professional education and competencies, patient and family education, and patient safety. The need to prevent infection and to monitor catheter malposition, vital signs, and complications were emphasized. Recommendations included certification of staff who administer intraspinal analgesia, patient protection from infection, appropriate patient monitoring, and comprehensive discharge planning to support this therapy.
• Indications that were supported across all consensus documents for this therapy were intractable pain that could not be controlled by other methods and side effects from conventional routes that prevented dose escalation.
• The most clinically relevant findings were with the use of nonopioids.

Intraspinal analgesia for cancer pain has been shown to provide adequate pain control and fewer side effects than conventional therapy. Because this is an infrequent intervention, high-quality evidence evaluating effectiveness is limited; however, effectiveness has been demonstrated in carefully selected patient groups with intractable pain. Nonopioid effectiveness suggests that use may be most beneficial in situations of opioid refractory pain.

The intraspinal route should be considered as part of a comprehensive pain management strategy. To ensure patient safety, this approach requires appropriate resources and staff guidance via policy and procedures.

To assess the efficacy of Octenidol^®, Glandomed^®, and chlorhexidine mouthwash in the prevention of mucositis and the reduction of the oropharyngeal flora

An oral rinse of 100 ml with 50 cc of chlorhexidine or Octenidol was applied to buccal, pharyngeal, gingival, and tooth surfaces for 30 seconds four times per day in the strata 1 group. The strata 2 group used a Glandomed solution 100 ml rinse with 500 cc of Glandomed or Octenidol applied to pharyngeal, gingival, and tooth surfaces for 30 seconds four times a day. Oral swab samples were taken and incubated for 36–48 hours.

• N = 93  
• MEAN AGE RANGE = 41.4–65.2 years
• MALES: 70.7% (strata 1); 84% (strata 2), FEMALES: 31% (strata 1); 52.2% (strata 2)
• KEY DISEASE CHARACTERISTICS: Strata 1 included patients who were ventilated for ≥ 24 hours independently of a specific diagnosis. Patients randomized to strata 2 received myeloablative, allogeneic, or autologous hematopoietic stem cell transplantation after receiving high-dose chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: All patients were aged 18 years or greater and were admitted inpatients. 

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: University Hospital Marburg in Germany

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care and palliative care 

Prospective, double-blinded, randomized, controlled study dividing patients into two strata

• The Oral Mucositis Assessment Scale (OMAS) and World Health Organization (WHO) mucositis scoring systems were used to determine levels of mucositis.
• A statistic analysis was performed using the SPSS package.

Both strata showed low OMAS and WHO scores, which did not differ significantly between the groups. Overall oropharyngeal flora was significantly reduced in the Octenidol group compared to the chlorhexidine and Glandomed groups.

All solutions resulted in low grades of mucositis according to the OMAS and WHO scoring systems. Octenidol reduced oropharyngeal flora more than chlorhexidine and Glandomed.

• Small sample (< 100)
• Risk of bias (no control group)

In this study, Octenidol proved to be superior to chlorhexidine and Glandomed in reducing oropharyngeal flora. This could potentially reduce the occurrence of hospital-acquired infections and ventilator-associated pneumonia.

To see the preventive effect of a sage tea–thyme–peppermint hydrosol oral rinse used in combination with oral care

This study aimed at discovering the preventive effect of sage tea–thyme–peppermint hydrosol oral rinse four times a day in addition to oral care (saline rinse and teeth brushing) in patients receiving chemotherapy regimens using 5-fluorouracil (5-FU). The study collected data through a patient questionnaire, the World Health Organization (WHO) Oral Toxicity Scale, oral cavity photos, and compliance checklists. The study completed assessments at 5 and 14 days after the completion of chemotherapy.

• N = 60, 30 in control group and 30 in intervention   
• MEAN AGE = intervention group: 52.6 years (SD = 8.2 years), control group: 48.7 years (SD = 10 years)
• MALES: 40%, FEMALES: 60%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Colon cancer (majority), solid tumor 
• OTHER KEY SAMPLE CHARACTERISTICS: Denture use varied in the control and intervention groups.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Ankara, Turkey

PHASE OF CARE: Active antitumor treatment

Patients receiving bolus or infusion of 5-FU chemotherapy were randomly assigned to the intervention or control group.

Measurement tools used included a patient questionnaire, the WHO Oral Toxicity Scale, oral cavity photos, and compliance checklists (self-reported by the patients).

Using kappa analysis, the kappa coefficient on day 5 was 0.98 and on day 14 was 0.85 in the intervention group. Oral mucositis in the invention group occurred in 30% of patients compared to 60% of patients in the intervention group. Grade 1 mucositis was statistically lower in the intervention group (10%) versus the control group (53.3%) on day 5 (p < 0.001). Grade 2 mucositis occurred more in the intervention group (20%) versus the control group (6.7%); on day 5, there was no statistical significance. On day 14, 93% of patients in the intervention group did not have mucositis and 96% in the control group did not have mucositis. No grade 3 or 4 mucositis occurred during this study.

Oral mucositis occurred in only 30% of the intervention group compared to 60% of the control group. The sage tea–thyme–peppermint hydrosol rinses are cost-effective, well tolerated, safe, and noninvasive. This intervention may be effective, but more randomized, controlled clinical trials of different types of treatment, as well as larger sample sizes, are needed.

• Small sample (< 100)
• Risk of bias (no blinding)
• Lack of follow-up
• Some patient-reported data

This intervention is a low-cost, effective, and well tolerated intervention. One downside is that this hydrosol needs refrigerated, and the solution needs to be analyzed in the pharmacy for consistency. Nurses need to educate patients and reinforce the importance of oral hygiene and adherence to the schedule of oral rinsing with this solution four times a day. This intervention may be effective but needs more research and data to show its effectiveness.

To determine the effectiveness of a standardized yoga intervention compared to usual care for improving sleep quality among cancer survivors

Patients were stratified by sex and baseline sleep disturbance and randomized to yoga or usual care groups. Patients in the yoga group participated in a program of gentle Hatha yoga and restorative yoga for four weeks. Sessions were provided in community-based sites (e.g., community centers, yoga studios) in groups of 10–15 patients. Study measures were obtained at baseline and at the end of the four-week sessions.

• N = 221
• MEAN AGE = 54.1 years
• MALES: 4%, FEMALES: 96%
• KEY DISEASE CHARACTERISTICS: 75% had breast cancer; 91% had previous surgery; 71% had chemotherapy; 66% had radiation therapy; 51% were on current hormone therapy; the average time since cancer treatment was 16.3 months.
• OTHER KEY SAMPLE CHARACTERISTICS: 48% were not exercising at baseline; 72% were married or in a long-term relationship; all reported at least a level 3 of sleep disturbance on a 10-point numeric scale.

• SITE: Multi-site  
• SETTING TYPE: Outpatient  
• LOCATION: United States

• PHASE OF CARE: Transition phase after active treatment

• RCT
  • Single-blind

• Pittsburgh Sleep Quality Index
• Actigraphy

Those assigned to the yoga intervention attended an average of 6.5 of 8 prescribed sessions. Compared to patients in the control group, participants in the yoga program showed greater improvement in global sleep quality (OR 10.79, p = .009), less daytime dysfunction (OR 0.381, p < .001), less sleep medication use (OR 0.561, p = .046), and improvement in subjective sleep quality (OR 0.631, p =.047). Global sleep quality, sleep disturbance, sleep efficiency, and subjective sleep quality also improved in patients in the control group. No significant differences were seen between groups in actigraphy findings.

Participation in group yoga sessions had a positive impact on self-reported sleep quality among cancer survivors.

• Baseline sample/group differences of import
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals of 10% or greater
• Other limitations/explanation: At baseline, global sleep quality was higher in the intervention group; however, no analysis was provided of the significant of this difference. Use of other interventions for sleep are not discussed, other than sleep medication use, which is not defined. Sessions were done in groups, so to what extent effects seen were because of the yoga exercises versus the group activity and relationships is unclear. The dropout rate was almost 50% in both study groups.

Findings suggest that participation in group yoga sessions may be effective in improving self-reported sleep quality among cancer survivors. This type of activity may not be acceptable to all patients, given the dropout rates seen in this study. However, for those who are interested in this type of intervention, nurses can let patients know that it can be of benefit.

To examine the efficacy of polarity therapy (PT) for reducing cancer-related fatigue and improving health-related quality of life (HRQOL) in women receiving radiation treatments for breast cancer.

Patients were treated with one of three arms: standard clinical care, standard clinical care plus three modified massages, or standard clinical care plus 3 PT treatments. Patients were asked to lie on their back and stomach, and treatments lasted about 75 minutes. For the PT treatments, the therapist used hand positions to examine energy flow, discover trigger points, and restore homeostatic energy flow. For the modified massage treatments, therapists used a modified Swedish massage applied over the clothing, and areas to be massaged were left to the discretion of the patients. Information was collected through daily diaries and weekly questionnaires completed by the patients. Participants were recruited by a clinical research coordinator with a referral from their treating oncologist.

• Final sample size used for the analysis was 43 female participants.
• Mean age was 52.9 years. 
• All participants were diagnosed with breast cancer (stage 0–IV).
• Thirty-eight of 43 patients were Caucasian.

This was a randomized, controlled trial.

• The Brief Fatigue Inventory (BFI) was used for the primary outcome measure. 
• Daily fatigue diaries were used to assess fatigue at its worst during the day and were completed at bedtime.
• HRQOL was assessed using the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue.

The baseline BFI showed a significant difference in baseline fatigue scores. The standard care group had a mean of 1.8, the massage mean was 3.0, and the PT mean was 3.7.  BFI scores, fatigue diaries, and HRQOL measures across the three intervention weeks showed no significant differences between the three groups.

This study did not show a significant improvement in fatigue scores between the groups. The interventions were well received by participants, and no adverse effects were reported, suggesting that this intervention could be further studied with a larger sample size.

• The study had a control group that received less attention due to a lack of therapeutic interventions compared to the other two groups, but the massage arm seemed to suggest an effective method to control for attention.
• The study group was comprised of one diagnosis and gender.

To determine the efficacy of palonosetron combined with dexamethasone in prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving multiple-day chemotherapy and the efficacy of a second dose of palonosetron in treating breakthrough emesis

An historic control group was used. Group O received ondansetron (8 mg IV) as a single dose on day one, along with dexamethasone each day of the regimen. Breakthrough emesis was treated with metoclopramide in the control group (but only after 72 hours following the first dose).

• The study consisted of 91 participants, which included 45 historic cases.
• The median age in the study group (P) was 51 years with a range of 15–80. The median age in the control group (O) was 50 years with a range of 20–77.
• The study sample was 37% female and 63% male; the control sample was 40% female and 60% male.
• Diagnoses were non-Hodgkin lymphoma, Hodgkin lymphoma, and acute myeloid leukemia.
• Patients in both the control and study groups received similar chemotherapy regimens with a total of 180 total cycles of chemotherapy administered in the study group and 173 cycles administered in the control group.

This study was conducted at a single inpatient setting in Palermo, Italy.

All patients were in active treatment.

This was a prospective trial with historic control comparison.

The number of vomiting episodes, grade of nausea (grading scale included), and need for rescue therapy were recorded in patient diaries.

• Nausea and vomiting were absent in 80% of patients of the study (P) group and 60% in the control (O) group (p < 0.05).
• In the study (P) group, 67% of patients who experienced CINV were successfully rescued by a second dose of palonosetron, whereas in the ondansetron group, 22% were successfully rescued after treatment with metoclopramide (p = 0.04).

Palonosetron was effective for prophylaxis of CINV and for treatment of breakthrough emesis in the setting of multiple-day chemotherapy.

• No concurrent control or random patient assignment was used.
• Use of retrospective comparison to ondansetron is based on the premise that repeat dosing of ondansetron in multiple-day regimens is not effective and uses a different type of medication for breakthrough emesis, thus decreasing the utility of this as an effective control group.

Palonosetron demonstrates effective prevention of acute CINV in the setting of multiple-day chemotherapy regimens and treatment of breakthrough emesis when repeated 72 hours after the initial dose.

Patients with malignant melanoma received paroxetine or a placebo two weeks prior to initiation of interferon alfa, continuing for the first 12 weeks of therapy. Study tablets contained 10 mg paroxetine; both groups took one tablet daily for a week, followed by 2 tablets daily for a week. Two weeks after the initiation of interferon alfa (four weeks after beginning paroxetine or placebo), the dosage of the study medication could be increased up to four tablets per day at the discretion of the study psychiatrist. The average number of tablets at the maximal dose for each group was 3.1. Patients were evaluated at baseline and at regularly scheduled intervals for the first 12 weeks of therapy.

40 adult patients with malignant melanoma that had been resected but was estimated to have a greater than 50% chance of recurrence

Single site

Randomized, double-blind study

• Hamilton Rating Scale for Depression
• Carroll Rating Scale for Depression
• Hamilton Rating Scale for Anxiety
• Neurotoxicity Scale

• Major depression symptoms developed in 2 of 18 patients (11%) in the paroxetine group  and 9 of 20 (45%) in the placebo group.
• Paroxetine treatment significantly decreased the likelihood that interferon alfa therapy would have to be discontinued because of severe depression.

The sample size was small. One disease group and one site were involved in the study.