DOI Link: doi: 10.1002/(SICI)1097-0142(19970715)80:2<250::AID-CNCR13>3.0.CO;2-T

The study was conducted to determine

• Whether patients with brain tumors could benefit from rehabilitative interventions already shown to be effective for patients with traumatic brain injury (TBI)
• Whether the resources expended on the rehabilitation of patients with brain tumors compare favorably with those expended on patients with head trauma
• Whether the benefits gained would suggest that the availability of such services on a broader scale should be encouraged.

Interventions were individualized after initial evaluation of each participant’s cognitive, behavioral, affective, and social functioning. This initial evaluation included an interview with the participant and at least one significant other. In some cases, home visits or observations of the participant in a community setting (e.g., work site) were performed.

Interventions were provided by various professionals (e.g., psychologists, speech pathologists, occupational therapists, and vocational specialists). Therapy was conducted in both individual and group settings, with a typical therapy day lasting five hours. Participants and their significant others received concurrent education and counseling services.

Measures were taken upon admission to the program, at discharge, and at follow-up (an average of eight months after discharge).

• The number of participants was 13.
• All participants had a primary malignant brain tumor. 
• All participants underwent surgical resection and radiation therapy; 12 also received chemotherapy.
• There were 8 male and 5 female participants.
• The average participant age was 34.3 ± 10 years.
• The average years of education per participant was 15.1 ± 1.7 years.
• The average time from diagnosis to admission to program was 75.4 ± 87.9 months.
• Participants were selected retrospectively based on diagnosis and availability of adequate medical records to characterize their tumors and courses of therapy.

The study took place at the Institute for Rehabilitation and Research Challenge Program in Houston, TX. 

This was a retrospective study. 

A neuropsychological test battery was conducted, with tests for the following domains: intellectual, verbal memory, visual memory, executive functions, language, visual perception, motor, and mood. The measurement instruments were unnamed.

Independence and productivity status rating scales were completed on admission, discharge, and follow-up to the program. Rating scales were shown to be sensitive to patient improvement in previous studies of patients with TBI. Specifics include:

1. An independence rating scale ranging from maximal independence, selected monitoring, and frequent monitoring to attendant care
2. A productivity status rating scale ranging from competitive employment, a modified job, educational or vocational training, homemaker role, and avocational pursuits to non-productive status.

Improved independence for six patients and improved productivity status for eight patients was demonstrated from baseline measurements. The average cost of treatment was $5,471.19 ± $3,200.73. The average number of treatment days was 20 ± 12.85.

 

 

The study provides preliminary support for the use of treatment approaches originally designed for patients with TBI.

• The study had a small sample size, with substantial variability in participants' diseases and treatment.
• The sample may not be representative of other groups of patients with brain tumors.
• The sample was based on a referral method.
• There was a short average time from treatment to follow-up.
• Participants had varied days of treatment and treatment duration.
• Ratings of independence and productivity status were potentially subject to bias.
• The study did not evaluate the means by which the rehabilitation program improved patient functioning.

DOI Link: doi: 10.1016/j.jpainsymman.2006.05.018

The intervention was cognitive behavioral therapy (CBT) offered as telepsychology. A clinical psychologist provided one-hour brief CBT to rural patients with cancer in Australia via videoconferencing. These brief CBT sessions were held weekly or biweekly for one to six sessions, depending on the patient’s Distress Thermometer rating and clinical judgment of oncology staff caring for the patient. After formal assessment, a treatment plan was individualized to include cognitive behavioral techniques, such as problem solving, activity scheduling, and controlled breathing. Each patient came to the rural clinic for the intervention. A staff member was in attendance with the patient throughout the videoconference session. Questionnaires were offered at pretreatment, post-treatment, and one month follow-up. The pretreatment questionnaire included demographic information, previous treatment by a psychologist, current use of psychotropic medications, time of initial diagnosis, and current cancer treatment prescribed.

• The sample included 25 patients with cancer living in rural Australia who scored 7+/10 on a Distress Thermometer tool or who were clinically identified by staff.
• All patients in the study received the intervention.

Rural Australia

A longitudinal pilot study design was used.

• Hospital Anxiety and Depression Scale (HADS): To assess anxiety and depression
• Functional Assessment of Cancer Therapy–General (FACT-G): To assess quality of life
• Patient satisfaction: 17 questions to assess patients’ attitudes toward their telepsychology experience postintervention

• The study needed 165 participants to make power levels: analyses of effect size was done with reported p values (p = 0.01).
• Patient anxiety levels over the intervention period decreased significantly, with large effect size sustained over one month.
• Anxiety scores (part of HADS) were F = 5.55, p = 0.01, and eta² = partial squared (magnitude of association) = 0.33.

The traditional “standard“ dose” of CBT is six to eight weeks (9–12 hrs) of therapy in a group setting. Even with this study’s “inadequate” dose of therapy, the individual, brief CBT made a significant decrease in patients’ anxiety levels.

• Lack of control group and limited sample size were significant flaws of the study.
• The study was a small pilot with numerous confounding variables (e.g., type of psychotropic medication taken, type and stage of cancer, time since diagnosis of cancer).
• Presence of a staff member during videoconference, which may have inhibited patient responses to therapy, was a minor flaw.

The intervention was CBT offered as telepsychology. A clinical psychologist provided one-hour brief CBT to rural oncology patients in Australia via videoconferencing. These brief CBT sessions were held weekly or bi-weekly for one to six sessions, depending on the patient’s ―Distress Thermometer‖ rating and clinical judgment of oncology staff caring for the patient.

After formal assessment, a treatment plan was individualized to include cognitive-behavioral techniques, such as problem solving, activity scheduling, and controlled breathing. Each patient came to the rural clinic for the intervention. A staff member was in attendance with patient throughout the videoconference session.

Longitudinal pilot study. 24 Australian rural oncology patients scoring 7+/10 on distress thermometer tool or clinical identification by staff caring for the patient received the intervention.

All patients in this study received intervention. Questionnaires offered at: pretreatment, post-treatment, and one month follow up.

Pre-treatment questionnaire included: demographic information, previous treatment by a psychologist, current use of psychotropic medications, time of initial diagnosis, and current cancer treatment prescribed.

HADS FACT-G (QOL)

Pt satisfaction asking about pt attitude toward telepsychology experience

Needed 165 participants to make power levels: analyses of effect size done with reported p values p=0.01. Patient anxiety levels over intervention period decreased significantly with large effect size sustained over 1 month. Anxiety scores (part of HADS) F=5.55, p+0.01 and n2=partial squared (magnitude of association) = 0.33.

The traditional ―standard ―dose‖ of CBT is group therapy setting of 6- 8 weeks (9-12 hrs) of therapy. Even with this study’s ―inadequate‖ dose of therapy, the individual, brief CBT made a significant decrease in anxiety levels.

A significant flaw of this study is lack of control group and limited sample size. This is a small pilot study with numerous confounding variables (type of psychotropic medication taken, type and stage of cancer, time since diagnosis of cancer).

A minor flaw was the presence of staff member during videoconference as this may have inhibited patient responses to therapy.

DOI Link: doi: 10.5414/CP201880

To compare the efficacy and safety of posaconazole and fluconazole in the prevention of invasive fungal infection (IFI) in Chinese patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) receiving chemotherapy

Patients in China with MDS or AML with persistent chemotherapy-induced neutropenia (expected to last longer than seven days) were enrolled. Posaconazole or fluconazole was administered for a maximum of 12 weeks, or until recovery from neutropenia and complete remission or until IFI was diagnosed. The endpoint was incidence of proven, probable, or possible IFI during treatment.

• N = 244  
• AGE = 18–70 years; median in posaconazole group was 40 years (range: 17–61 years), median in fluconazole was 40 years (range: 15–68 years)
• MALES: Posaconazole, 55%; fluconazole, 52%  
• FEMALES: Posaconazole, 62%; fluconazole, 65%
• KEY DISEASE CHARACTERISTICS: De novo AML (posaconazole, 56%; fluconazole, 60%; relapsed AML (posaconazole, 46%; fluconazole, 45%); MDS (posaconazole, 15%; fluconazole, 12%)
• OTHER KEY SAMPLE CHARACTERISTICS: Duration of neutropenia in posaconazole (less than two weeks, 52%; more than two weeks, 65%); in fluconazole (less than two weeks, 55%; more than two weeks, 62%)

• SITE: Multi-site   
• SETTING TYPE: Outpatient   
• LOCATION: China

• PHASE OF CARE: Active antitumor treatment

• Prospective, randomized study

• Fisher’s method was used for analyzing between-group comparison. 
• A Kaplan-Meier analysis was used to calculate time-related parameters, including the time to first onset of proven, probable, or possible IFI, and time to first use of empirical antifungal therapy (from day of randomization).
• Log-rank tests were used for comparison between groups.

Two hundred forty-five patients entered safety analysis (124 in posaconazole and 121 in fluconazole). After exclusions, 117 patients were included in each set. Incidence of IFI was 9.4% and 22.2% in the posaconazole and fluconazole groups, respectively. There was a difference in rates of -12.8% in favor of posaconazole. There was an incidence of 3.42% when only proven and probable diagnoses were considered. Noninferiority of posaconazole compared with fluconazole was established with a difference in incidence rate of -5.98%. The 100-day time to first onset of proven, probable, or possible IFI was 13.8 (SD = 3.5%) in the posaconazole group and 29.2 (SD = 4.6%) in the fluconazole/itraconazole group.

Antifungal prophylaxis has been shown to be a successful strategy in patients at high risk for IFI. Posaconazole showed significant advantage compared with fluconazole in reducing the incidence of IFI. The advantage of posaconazole in decreasing the incidence may translate into reduced need for systemic antifungal treatment.

The study raises awareness of the potential for use of posaconazole as a reasonable prophylactic medication for IFI. There is some evidence that second-generation azoles may be more effective for prophylaxis in high-risk patients.

DOI Link: doi: 10.1001/jama.284.21.2755

To compare the effectiveness of electroacupuncture, minimal needling and mock electrical stimulation, or antiemetic medications alone in controlling emesis among patients undergoing highly emetogenic chemotherapy

Participants were randomly assigned to one of three groups.

• Low-frequency electroacupuncture at classic antiemetic acupuncture points once daily for five days
• Minimal needling at control points with mock electrostimulation once daily for five days
• No adjunct needling

• The study consisted of 104 patients.
• The mean age was 46 years with a range of 18–62 years.
• All participants were women with histologically proven resected breast cancer undergoing myeloablative chemotherapy, Karnofsky scores of 80 or more (on a 0–100 scale), and life expectancy of at least six months. All participants were appropriate candidates for bone marrow transplantation.
• Patients were excluded from the study if they had brain metastases, cardiac pacemakers, life-threatening concurrent nonmalignant conditions, or active skin infections over the proposed treatment area.

Participants were from an inpatient unit at a tertiary hospital with a comprehensive cancer center. Patients were recruited from oncology clinics.

The study design was random, without stratification.

Investigators recorded the total number of emetic episodes during the five-day study period and the proportion of emesis-free days across the treatment groups.

• The electroacupuncture group had significantly fewer emesis episodes than the minimal needling group or the pharmacotherapy group alone (p < 0.001).
• The minimal needling group had significantly fewer episodes of emesis than the pharmacotherapy group alone (p = 0.01).
• The electroacupuncture group had a greater proportion of emesis-free days than the other groups (p < 0.001).
• No significant difference existed between the groups over days 6–14.

• Homogeneity of sample (standard chemotherapy and supportive care) helped to increase the precision in measurement; however, generalizability is limited.
• The study did not include 5-HT₃ antagonists or corticosteroids.
• Training is required for electroacupuncture and minimal needling. The two investigators administered the procedure (training completed with 3–20 years of experience).
• Time commitment was 30 minutes a day for five days.
• This was a grant-funded project. 

• The beneficial effect of electroacupuncture may be related to attention and clinician-patient interaction.
• Minimal needling led to a reduction in emesis, which could have been a placebo effect.
• Electroacupuncture has been thought to modulate serotonin, substance P, and endogenous opioids (similar to drugs that are available now).

DOI Link: doi: 10.1002/cncr.28973

To examine the effects of electrostimulation at the K1 acupoint located on the sole of the foot on chemotherapy-induced nausea and vomiting (CINV)

After institutional review board approval, 103 patients with metastatic liver cancer undergoing transcatheter arterial infusions (TAIs) of cisplatin or oxaliplatin were recruited and randomized to group A (tropisetron and electroacustimulation at the K1 acupoint) or B (tropisetron and electrostimulation at a placebo point on the heel). The treatment in both groups lasted for 20 minutes one to two hours before TAI on day 1 and then daily (7 am–9 am) for the subsequent five days. The baseline rate, intensity, and duration of CINV were collected for five days after TAI. Quality of life was assessed daily.

• N = 103 (51 in group A and 52 in group B)
• MEAN AGE = 53.4 years (range = 20–73 years)
• MALES: 80 (77.7%), FEMALES: 23 (22.3%)
• KEY DISEASE CHARACTERISTICS: Liver cancer (primary and metastatic)
• OTHER KEY SAMPLE CHARACTERISTICS: Participants aged 18–75 years scheduled to receive cisplatin or oxaliplatin via TAI for the first time; negative pregnancy test for fertile female patients; no local skin infections near the acupoints; no cerebrovascular accidents; no intestinal obstructions; no vomiting or 5HT3 receptor antagonist or other antiemetic use within 24 hours before TAI; no cardiac pacemaker; not currently using acupuncture; and no mental incapacity or psychiatric disorder

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Fudan University Shanghai Cancer Center in Shanghai, China

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

Double-blinded, randomized, placebo-controlled, longitudinal clinical trial

• Daily diaries recording episodes of emesis, the time when each episode occurred, the degree of emesis, and a rating for nausea duration and severity in the previous 24 hours
• Visual Analog Scale (VAS) on 0–10 scale used to record nausea intensity
• Medications record 
• Quality of life was assessed daily using the MD Anderson Symptom Inventory (MASI) and the EuroQoL scale (24 hours)

No differences were found between groups A and B in regard to the incidence and degree of nausea or vomiting at any time point. Patients in group A had better EuroQoL scores than patients in group B (72.83 versus 65.94, p = 5.04) on day 4 but not other days. No group differences were noted at any time point for MASI scores.

Noninvasive electrostimulation of the K1 point combined with tropisetron had no effect on cisplatin-induced or oxaliplatin-induced nausea or vomiting.

• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Needed acupuncturist to locate the site of stimulation; did not follow antiemetic guidelines and did not give dexamethasone with tropisetron; gave extra antiemetics for patients who experienced CINV; opioid use was not assessed; and frequency of electrostimulation administration was not sufficient

Patients receiving chemotherapy experience CINV frequently with highly emetogenic regimens. Complementary therapies might be helpful in reducing this side effect. Instructing patients to refer to their physicians before trying a new intervention is advisable.

DOI Link: doi: 10.1177/1099800416683801

To explore the effects of acupressure on chemotherapy-induced nausea and vomiting (CINV)

A convenience sample of patients was recruited, and patients were randomized to receive acupressure on two sites on both sides of the body or acupoint patches on a single site on both sides of the body. All patients were receiving standard triplet antiemetics. Study data were collected prior to and after the acupressure intervention and 48 hours after chemotherapy. Study data were collected three times—before chemotherapy, before dinner on the day of chemotherapy, and before breakfast on the following day. The acupressure group had pressure applied to the PC6 and SP4 points on both sides of the body, for three minutes on each point.

• N = 70   
• MEAN AGE = 58.6 years (SD = 0.2)
• MALES: 61.4%, FEMALES: 29.6%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had lung cancer and were receiving cisplatin-based chemotherapy.

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: Taiwan

PHASE OF CARE: Active antitumor treatment

Two group, randomized trial

• Morrow Assessment of Nausea and Emesis (MANE)
• Meridian Energy Analysis Device

The mean meridian energy was significantly higher in the group receiving acupressure after the intervention (p = 0.003) compared to those who had acupoint patches. Analysis showed an effect on study groups across all study measurement times, with lower nausea (p < 0.001) and vomiting (p = 0.023) severity in the acupressure group.

Acupressure on PC6 and SP4 acupoints prior to chemotherapy and meals was associated with a lower severity of nausea and vomiting.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable

The use of acupressure as an adjunct to standard antiemetic treatment may reduce the severity of CINV in patients receiving emetogenic chemotherapy. Nausea is still not well controlled in most individuals with maximal antiemetic use. Acupressure is a low-risk intervention that may be helpful for CINV control, specifically nausea control.

DOI Link: doi: 10.1016/j.jpainsymman.2007.05.008

To evaluate the effectiveness of educational interventions in reducing patients’ nausea expectations by dispelling misconceptions about chemotherapy-induced nausea and vomiting (CINV) and building confidence in antiemetic regimens

Patients were randomized one of two arms. Both arms received the same educational materials except that arm 2 patients received an additional handout emphasizing the benefits and effectiveness of ondansetron in the control of nausea and vomiting. Both arms received a standardized antiemetic regimen including ondansetron and dexamethasone on day one. Nausea and vomiting were measured in a patient-reported diary from day one to day four following chemotherapy treatment.

• The study consisted of 322 patients who were chemotherapy-naïve.
• The mean age in arm 1 (control group) was 57.8 years (SD = 13.4 years, n = 163). The mean age in arm 2 (intervention group) was 57.4 years (SD = 12.1 years, n = 59).
• The majority of the patients were female (73%).
• Diagnoses were not reported.
• In arm 1, 52.1% of patients were receiving adriamycin, 34.4% were receiving carboplatin, and 13.5% were receiving cisplatin. In arm 2, 52.8% of patients were receiving adriamycin, 31.4% were receiving carboplatin, and 15.7% were receiving cisplatin.

The study was conducted at 18 medical oncology practices (all Community Clinical Oncology Programs [CCOPs]) across the United States.

All patients were in active treatment.

This was a randomized, multicenter, clinical trial.

• Expectation of nausea was measured using a five-point Likert-type scale anchored at one end by “1” = I am certain I WILL NOT have nausea” and the other end “5” = I am certain I WILL have nausea.
• Patients measured nausea and emesis four times a day and recorded their experiences in report diaries.
• Assessments were documented from the treatment day until the fourth day following the chemotherapy treatment.
• Nausea severity was assessed on a 7-point rating scale.

• No significant difference was found between groups in frequency or severity of nausea.
• Approximately 76% reported no nausea, and approximately 25% experienced or average nausea.
• A significant reduction in nausea expectancy was seen in the intervention group as compared to the control group (p = 0.024).

Although the expectancy manipulation reduced patients’ reported expectations for the development of nausea, the occurrence of nausea was not reduced. Changing nausea expectancies did not affect the occurrence of nausea.

• The expectancy manipulation in this study may not have been strong enough. The educational intervention was a one-page handout with basic statements.
• Use of a reliability and validity expectancy measurement tool was not documented.
• Past experiences of nausea and vomiting (motion or morning sickness) or the influence of past exposures to family or friends undergoing chemotherapy, which may have influenced chemotherapy-related nausea, was not considered.

Educational interventions to increase awareness of nausea prior to first chemotherapy administration may reduce patients’ expectations for subsequent CINV. However, these interventions may not reduce actual nausea severity or occurrence.

DOI Link: doi: 10.1111/ajco.12288

To assess the efficacy of prophylactic benzydamine in an oral solution for reducing the signs and symptoms of oral mucositis in patients receiving radiation therapy (RT) with or without chemotherapy for head and neck cancers

A 0.15% benzydamine or placebo oral rinse of 15 ml was used for two minutes four to eight times daily starting the day before RT and continuing till two weeks RT completion.

• N = 51  
• MEAN AGE = 52.65 years
• MALES: 60.8%, FEMALES: 39.2%
• KEY DISEASE CHARACTERISTICS: Head and neck cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Adults receiving at least 5,000 cGy RT via megavoltage treatment with either cobalt 60 or a linear accelerator to at least two oral mucosal sites with a Karnofsky Performance Status (KPS) > 60

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Jorjani Cancer Center at the Shahid Beheshti University of Medical Sciences in Tehran, Iran (2009–2012)

• PHASE OF CARE: Active antitumor treatment

Randomized, double-blinded, placebo-controlled trial stratified according to KPS and treatment schedule (once- or twice-daily fraction) and then randomized

• The oral cavity was divided into 14 anatomical sites.  
• A complete oral examination was done weekly after the initiation of treatment, and a four-point scale was used to score each oral site.  
• At each weekly visit, an overall mean score was calculated based on at-risk areas.

No difference in the severity of mucositis was found during weeks 1–3. By week 4, the placebo arm had significantly more mucositis than the treatment arm (p = 0.01), and this trend continued until the end of treatment. The difference in the mean score at one and two weeks after treatment continued to show lower scores in the treatment group, but this was nonsignificant.

An oral rinse of benzydamine 0.15% was safe and well-tolerated with no noticeable side effects reported by patients. It reduced the incidence and severity of radiation-induced oral mucositis.

• Small sample (< 100)
• Risk of bias(sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: Single site; unable to analyze data regarding analgesic consumption because of noncompliance; unclear who did the oral examination and training to ensure interrater reliability

Benzydamine was well-tolerated, easy to administer, and may be an appropriate prophylactic treatment for oral mucositis in patients receiving RT for head and neck cancer.

To evaluate the safety and efficacy of single-dose palifermin in reducing oral mucositis incidence in patients with hematologic malignancies undergoing peripheral blood progenitor cell transplant receiving total-body irradiation and high-dose chemotherapy 

Patients were randomized to receive 60 mcg/kg palifermin once daily for three days before the start of fractionated total-body irradiation (TBI) (Arm A), 180 mcg/kg once only on day -1 (Arm B), day -2 (Arm C), or day -3 (Arm D) before starting fractionated TBI and stratified by etoposide use and number of days of TBI.  All patients received 60 mcg/kg for three days post-transplantation.

The study reported on 47 patients receiving high-dose chemotherapy with an age range of 18–74 years. Patients had multiple cancer diagnoses.

The World Health Organization (WHO) Oral Toxicity Scale was used.

• All arms had similar adverse effects.
• Overall incidence of severe mucositis was 61% with a mean of 4.3 days.
  • Arm A: 82% (70% actual)
  • Arm B: 60% (73% actual)
  • Arm C: 31% (38% actual)
  • Arm D: 75% (67% actual)

• The four study arm sample sizes were small.
• The total sample was small with only 47 patients total.
• The authors collapsed Arms B, C, and D for severe mucositis.
• A large percentage (n = 20) of patients had significant protocol deviations.
• The study was stopped early; participant accrual was difficult.
• The report did not include a discussion of costs.