To evaluate the efficacy of low-level laser therapy (LLLT) to decrease severe oral mucositis and reduce radiation therapy (RT) interruptions

 Patients received either gallium aluminum arsenide LLLT 2.5 J/cm² or placebo laser before each radiation fraction.

• The study reported on 75 patients with a median age of 55 years.
• The sample was 76% male and 24% female. 
• Patients had head and neck cancer, which was primarily squamous cell carcinoma.
• All patients underwent conventionally fractionated RT s-GY daily fractions, five times per week.

This was a single-site, outpatient study conducted in Brazil.

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blind, phase III study.

• The National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2, was used.
• A visual analog scale was used.

• Appearance of grade 3 mucositis was delayed in the patients treated with LLLT.
• Unplanned RT interruptions because of severe mucositis were necessary for six patients in the placebo arm and none in the LLLT arm.
• Pain scores and analgesic medication use were similar in the two arms.
• No significant differences were found between groups.

LLLT benefit was limited to fewer interruptions in RT.

• The sample size was small with fewer than 100 patients.
• Another dosage or a specific type of LLLT may be more effective.

LLLT dosage, schedule, specific laser type, and availability all need to be addressed.

STUDY PURPOSE: To determine if nystatin prophylaxis or treatment for fungal infection decreases morbidity and mortality in immunocompromised patients

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 14
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,569
• KEY SAMPLE CHARACTERISTICS: Twelve of the 14 trials studied nystatin prophylaxis, and two studied nystatin treatment. Eleven trials included patients with acute leukemia, solid cancer, or bone marrow transplantation. One trial involved patients with liver transplantation, one trial involved patients who were critically ill from surgery and/or trauma, and one trial involved patients with AIDS.

PHASE OF CARE: Active antitumor treatment

Nystatin cannot be recommended for prophylaxis or the treatment of Candida infections in immunodepressed patients.

Nystatin is no more effective than placebo for the prevention or treatment of fungal infections in immunocompromised patients.

To evaluate the efficacy and acceptance of acupuncture as an additive antiemetic treatment during highly emetogenic chemotherapy (HEC) in pediatric patients with cancer

Patients receiving chemotherapy were randomized to receive antiemetic medication plus acupuncture or antiemetic medication alone.

• Group 1 participants received acupuncture before chemotherapy, were offered acupuncture daily during chemotherapy, and received no acupuncture in their subsequent chemotherapy.
• Group 2 received treatments in the opposite order.

Acupuncture points were based on the acupuncturists’ decision, until the patient reported a “de Qi” sensation.

Antiemetic rescue medication, number of retching and vomiting episodes, and a short essay of the acupuncture experience were recorded.

• The sample consisted of 23 participants.
• The patients' ages ranged from 6-18 years with a mean of 13.6 years and standard deviation of 2.9 years.
• The sample was 56.5% female and 43.5% male.
• Diagnoses were Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, undifferentiated sarcoma, and synovial sarcoma.
• Patients who had full control of chemotherapy-induced nausea and vomiting (CINV) without need for antiemetic rescue medication during the first chemotherapy course were excluded from the study.

This study was conducted in multiple inpatient settings in five German cancer centers.

This was a prospective, randomized, crossover clinical trial pilot study.

An open-form essay was used to document the subjective experience of acupuncture.

In evaluating chemotherapy courses, overall, no significant differences were found in retching or vomiting episodes. In evaluating differences between group 1 and group 2, no significant effect was found with dexamethasone (p = 0.145); however, the acupuncture group was associated with lower phenothiazine medication use (p = 0.001) and less retching and vomiting episodes (p = 0.01).

Acupuncture with baseline antiemetic medication was associated with less phenothiazine use and less retching and vomiting among children receiving HEC.

• The sample was small.
• The number of times that the children received acupuncture depended on individual patient requests and was not recorded.
• Acupuncture sessions did not follow a standard procedure of needle placement, and differences among acupuncturists may provide differing results.
• The methods for recording retching and vomiting episodes were not documented.
• Although one of the study aims was to evaluate acceptance of acupuncture, the authors did not specify how this was measured.
• The title suggests that the study evaluated nausea, but this was not discussed.

Acupuncture may provide some relief of retching or vomiting episodes associated with HEC, but the intervention should be used in combination with standard antiemetic treatment.

To assess the effectiveness of hyperbaric oxygen (HBO) therapy on reducing arm lymphedema in patients with early-stage breast cancer

Participants were divided into the control and the experimental group at a ratio of 1 to 2, respectively. The experimental group received HBO therapy and breathed 100% oxygen at 2.4 atmospheres absolute for 100 minutes with two five-minute air breaks. The sessions were conducted 30 times in a six-week period or five times a week. Both the control and experimental groups received patient education on standard care for lymphedema and hosiery when appropriate.

• The study sample was comprised of 58 patients.
• Mean age of the control group was 62.1 years and the experimental group was 63.2 years.
• All patients had breast cancer and most (97%) had diagnosed lymphedema.
• Two patients had Hodgkin lymphoma with radiotherapy.
• Patients had finished adjuvant radiotherapy.
• Patients had a minimum of 15% increase in limb volume.

The study took place in multiple hospitals in the United Kingdom.

Patients were undergoing active lymphedema treatment.

The study used a randomized phase II study design.

• A Perometer measured limb volume.
• An 8% reduction was maintained as a clinically significant reduction in arm volume.
• Lymphoscintigraphy was performed to measure the fractional removal rate of the radioisotopic tracer at baseline and 12 months.
• Acquisitions were performed at 20, 60, 90, 120, and 180 minutes.
• The removal rate was calculated by the computer using a regression slope.
• Extracellular water content was measured at baseline and 12 months using dielectric constant measurements.
• Two measurements were taken: one third the distance from the antecubital crease to the forearm and one half the distance from the antecubital crease to the upper arm.
• Quality of life was assessed using the United Kingdom SF-36, completed before randomization into groups, at baseline, and at 3, 6, 9, and 12 months.

There was not a statistically significant change in limb volume between the control group (p = 0.64) and the experimental group (p = 0.50) at 12 months after baseline. The investigators define a positive response as an 8% reduction in arm volume. Thirty percent of the experimental group versus 18.8% of the control group responded to meet these criteria but was also statistically insignificant (p = 0.50). Lymphatic clearance rates were similar among groups and were not significant findings. Quality of life findings were similar among both groups and were not significant.
 

The study suggests that HBO therapy when added to best standard treatment of lymphedema in patients with breast cancer is not effective. The study does not confirm earlier reports of a therapeutic effect of HBO.

• The sample size was small, with less than 100 participants.
• The sample size for the control and experimental group were different, which could have affected the statistical analysis comparison and leaves room for imbalances.
• The study had a risk of bias because it had no blinding and the sample characteristics.
• The findings are not generalizable.
• The average time from radiotherapy treatment post-operatively to participation in the study was 12 years, which may also effect the results of remodeling of fibrotic tissues from HBO.

The study suggests that HBO therapy is an ineffective therapy for treating lymphedema in patients with breast cancer. The therapy should not be enacted into practice. Nursing researchers should analyze the randomized trial and non-randomized trials of this treatment program to identify confounding variables that may have made the non-randomized trial results significant and the randomized trial results not significant. If the study is repeated a larger sample size should be used.

To examine hyperbaric oxygen in the treatment of chronic arm lymphedema after radiotherapy

Patients received treatment with hyperbaric oxygen, compressed to 2.4 atmospheres absolute (ATA) in a multiplace category 1 hyperbaric chamber at Royal Hospital. Patients received 100% oxygen at pressure via a transparent hood. Total time at 2.4 ATA was 100 minutes, including two five-minute air breaks. Each participant received a total of 30 pressure exposures, treating five days per week for six weeks. The primary endpoint was an absolute change of greater than 20% in relative volume of the ipsilateral arm versus contralateral arm. The secondary endpoints were lymphoscintigraphy, patient self-assessments, and physician assessments. An unplanned endpoint was patient comments about arm softening and mobility as part of one relative change in arm volume. 

• The study sample was comprised of 20 female patients and 1 male patient.
• Patients were included if they had greater than or equal to 30% increase in arm volume, were free from cancer recurrence, physical and psychologic fitness for hyperbaric oxygen, and availability for follow-up and informed consent.
• All patients had axillary or supraclavicular radiotherapy.

The study took place at Royal Marsden Hospital based on observation from a previous study at the same institution evaluating hyperbaric oxygen in radiation-induced brachial plexopathy. In that study, two of the six patients with chronic lymphedema experienced major and persistent improvement in lymphedema.

• Magnetic resonance imaging of the supraclavicular fossa, axilla, and brachial plexus was done prior to treatment to exclude recurrence.
• Subcutaneous induration within the radiotherapy volume was clinically assessed.
• Arm volume was measured using a Perometer.
• Quantitative lymphoscintigraphy was used.
• Clinical photographs were taken.
• Patient completed self-assessments using EORTC QOL (QLQ-C30 and BR23)
• Clinical assessment and Perometer measurements were taken within one week of completing 6 weeks of treatment and at 6 and 12 months after start of therapy.
• Self-assessments occurred at the same intervals as clinical assessments plus three and nine months after start of treatment.
• Lymphoscintigraphy and clinical photos repeated at 12 months only.

Compliance with treatment was 100%. All questionnaires were returned, and only two patients missed follow-up assessments (one patient was hospitalized and the other moved); as a result, 94% of patients had Perometer measures. Only 71% participated in lymphoscintigraphy because of logistics, 7% missed follow-up scan at 12 months, and one scan was erased accidentally. Three patients responded according to defined 20% or greater reduction in arm volume, 16 were nonresponders. Mean percentage reduction in arm volume was 7.68. Quality-of-life measures were not clinically significant post-treatment. Comments by participants indicated they may not have been appropriate measures. Lymphoscinitgraphy improvement showed statistically significant changes.

Patients had good compliance with the treatment plan despite rigorous treatment. Median time since completion of the treatment is 14 years, which is encouraging given improvement in lymphoscintigraphy measures and limb tissue softening (a subjective measure).

• The sample size was small.
• The study did not have a control group or comparison group.

The study has sufficient data to justify a randomized controlled trial. Careful screening of participants is needed.

To evaluate the effects a brief telephone intervention on women experiencing a recurrence of breast cancer

Women were randomly assigned to either a telephone-intervention group (TG) or a control group (CG). TG received 4–8 counseling/information sessions by telephone at weekly intervals. Session content reflected primary patient concerns and common domains from a quality-of-life (QOL) model. After the first session, patients received an information packet. The packet consisted primarily of National Cancer Institute pamphlets. Counselors were breast cancer recurrence survivors at least one year postrecurrence. Assessments were completed at baseline, three months, and six months.

The study was conducted by SWOG (formerly the Southwest Oncology Group)—an organization, supported by the National Cancer Institute, that conducts clinical trials relating to cancer in adults.

• The sample was composed of 305 women experiencing the first recurrence of breast cancer.
• Characteristics of participants in both groups were well balanced except that, in the TG group, more patients received chemotherapy; in the CG group, more patients received hormone therapy.

Multisite

• Cancer Rehabilitation Evaluation System-Short Form (CARES-SF), to measure emotional well-being
• Center for Epidemiological Studies Depression Scale (CESD), to measure depression

Secondary-outcome assessments:

• Four-item scale as proposed by Reynolds et al., to measure social support
• Life Orientation Test (LOT), to measure optimism and pessimism
• Three-point question, to measure surprise regarding recurrence
• Sense of Coherence Scale (Antonovsky), to measure sense of coherence.

Support services utilized and satisfaction with the telephone intervention were requested.

The telephone intervention was feasible and well accepted, but authors noted no benefits associated with the intervention, in regard to either emotional well-being or depressive symptoms. Patient distress started and remained very high in this sample. Statistically significant was the fact that more CG patients progressed during the six months of the study than did members of the TG group.

This is a well-designed RCT with adequate sample size; however, the study’s generalizability is unclear, given that the patients came from multiple institutions across the United States. The catchment cannot be precisely described, and characteristics of refusing patients were not reported. This sample included high levels of psychological and disease-related disability, and telephone calls from a nonprofessional may not have been an appropriate means of modifying patient distress. The study presents no significant findings.

To compare the effectiveness of three different products in reducing incidence of radiodermatitis

Women were randomly assigned to placebo (sterile water mist), Aquaphor, Biafine or RadiaCare gel. Patients were instructed to apply the product two times daily with the start of radiotherapy and until treatment was complete. Patients were not to use any other skin care product on the affected area. The radiation nurse assessed patients weekly and reminded them to complete home journals. The investigators conducted independent skin assessments on a random sample of 10% of patients to establish reliability of observations.

• The study sample was comprised of 208 female patients.
• Mean age ranged from 54–56 years.
• All patients had stage 1 or 2 breast cancer.
• Median dose was 200 cGy daily with a total dose of 6200 cGy most often. 
• The average number of treatments was 31.

The study took place in an outpatient setting at Duke University.

Patients were undergoing active antitumor treatment.

The study used a double-blind placebo-controlled randomized four-group trial design.

• Radiation Therapy Oncology Group skin toxicity scoring was used.
• Patients kept a journal of application, satisfaction, and ease of use.

Ninety-five percent of patients had a skin reaction, with most occurring by week 4. None of the products tested showed a significant difference to reduce the incidence of grade 2–4 skin toxicity compared to placebo.  Increases in the proportion with a skin reaction were greatest among those using Biafine. Increases in skin reaction were similar to each other in the other study groups. Patient adherence to use was greater than 80% during the study. Biafine was associated with the greatest increase in toxicity across groups.

None of the products tested here were better than placebo in reducing incidence of grade 2–4 radiodermatitis.

Findings suggest that none of these particular products are effective, although a systematic review and meta-analysis in this area suggest that using anything is more effective than using nothing. Further well-designed research in prevention and management of radiodermatitis is needed.

To compare the effectiveness of three products in reducing the incidence of radiodermatitis.

Women were randomly assigned to placebo (sterile water mist), Aquaphor, Biafine, or radiacare gel. Patients were instructed to apply the product two times daily with the start of radiation therapy (RT) and until treatment was complete.  Patients were not to use any other skin care product on the affected area. The radiation nurse assessed patients weekly and reminded them to complete their home journals. The investigators conducted independent skin assessments on a random sample of 10% of patients to establish reliability of the observations.

• The sample was comprised of 208 women. 
• Mean age across all groups ranged from 54 to 56 years.
• Patients had stage 1 and 2 breast cancer.
• Median dose was 200 cGy daily, and total dose was 6200 cGy most often.
• The average number of treatments was 31.

• Single site 
• Outpatient  
• Duke

Patients were undergoing the active antitumor treatment phase of care.

The study was a double-blind, placebo-controlled, randomized, four-group trial.

• Radiation Therapy Oncology Group (RTOG) skin toxicity scoring
• Patient journal of application, satisfaction, and ease of use

Of the patients, 95% had a skin reaction, with most occurring by week 4. No product tested showed a significant difference in reducing the incidence of grade 2 to 4 skin toxicity compared to placebo. Increases in the proportion with a skin reaction were greatest among those using Biafine. Increases in skin reactions were similar to each other in the other study groups. Patient adherence to use was greater than 80% during the study.

 No product tested was better than placebo in reducing the incidence of grade 2 to 4 radiodermatitis.

Biafine, Aquaphor, and radiacare gel were no more effective than placebo in reducing the incidence of clinically relevant skin toxicity with RT in patients with breast cancer. Biafine was associated with the greatest increase in toxicity across groups. Findings suggested that none of these products are effective, although a systematic review and meta-analysis in this area suggests that using anything is more effective than using nothing. Further well-designed research in prevention and management of radiodermatitis is needed.

• To perform a meta-analysis to obtain a current, comprehensive, and robust estimate of the effect of psychosocial interventions on cancer-related pain
• To determine  whether the effects of psychosocial interventions on pain in patients with cancer differ by intervention type (skills- versus education-based approach)
• To explore, in the study context, the relationship between intervention design and patient sociodemographics

• Databases searched were MEDLINE, PsycINFO, CINAHL, EMBASE, and the Cochrane Library.
• Search terms indicating pain (e.g., pain, nociceptors) and presence of cancer (e.g., neoplasm, cancer, leukemia) were combined with terms relating to psychosocial interventions (e.g., psychotherapy, hypno$, desensitis$, meditate$) and publication types (e.g., randomized controlled trial, controlled clinical trial).
• Studies were included if they
  • Were published in English on a date that fell in a period after the earliest date available in each database and before 2011.
  • Included adult subjects (those 18 years old or older) with a diagnosis of cancer or who were undergoing procedures for diagnosis of cancer.
  • Employed random assignment.
  • Assessed pain.
  • Included a usual-care or no-treatment control condition.
  • Employed a psychosocial intervention—that is, any approach involving cognitive behavioral techniques, stress management, relaxation training, education, hypnosis, or other experiential techniques. (Interventions could be provided in any of multiple formats, including individual, group, couples, telephone, or Internet-based modality.)
• Studies were excluded if they used alternative therapies as the primary treatment, as is the case with massage and Reiki therapy.
   

The search retrieved 1,681 studies published 1996–2010. Three pairs of raters independently reviewed 1,681 abstracts, using an online coding program designed for this project. Studies meeting the inclusion criteria were evaluated for quality according to a modified seven-item coding scheme based on the Physiotherapy Evidence Database. The project leader reviewed findings from rater pairs, resolved discrepancies, and produced a final list of studies for full-text examination. The list of studies was divided among the three pairs of raters.
 

• The number of studies that met inclusion criteria was 42; 37 provided sufficient data for meta-analysis.
• The total sample was composed of 4,199 patients.
• Authors did not report the sample range.
• Of all patients, 66% were women. The sample was primarily white (72%). Most of the studies (65%) included cancer at various stages at baseline. At baseline, 54% of the sample was receiving chemotherapy. Of all patients, 71% were receiving outpatient care.

The weighted average effect size in 38 comparisons for pain severity (k = 38) was 0.34 (95% CI 0.23–0.46; p < 0.001). The weighted average effect size in four comparisons for pain interference was 0.40 (95% CI 0.21–0.60; p < 0.001). Among studies that measured pain severity, skills-based interventions yielded a higher but statistically nonsignificant effect size than did educational approaches (k = 18, g = 0.45 versus k = 19, g = –0.29, respectively; p = 0.22).

Psychosocial interventions decrease cancer-related pain severity and the extent to which pain interferes with activities. Both skills instruction and education approaches can improve the management of cancer pain.

To evaluate the tolerability, efficacy, and pharmacokinetics of aprepitant with a 5-HT₃ receptor antagonist and corticosteroid in adolescents with cancer

Patients were randomized to receive either a regimen of aprepitant plus dexamethasone and ondansetron or the control arm of ondansetron and dexamethasone. On the day of chemotherapy, aprepitant or placebo was administered 1 hour before and dexamethasone and ondansetron were given 30 minutes before chemotherapy. Rescue medication was permitted. Patient follow-up was done between days 6 and 8 and between days 19 and 29. Patients recorded episodes of vomiting in diaries for five days following chemotherapy. For the experimental arm, aprepitant was given at 125 mg day 1, 80 mg days 2 and 3, 4 mg day 4; 8 mg dexamethasone day 1, 4 mg days 2 and 3; and ondansetron at 0.15 mg/kg, three times per day on days 1 and 2. In the control arm, patients received 16 mg dexamethasone on day 1, 8 mg on days 2–4, and ondansetron at 0.15 mg/kg, three times per day on days 1 and 2.

• The study consisted of 40 participants.
• The mean age was 15 years old, with a range of 11–19 years.
• The sample was 29% female and 61% male.
• The most common diagnosis was bone sarcoma.
• Patients were scheduled to receive emetogenic chemotherapy or had previously intolerable therapy because of chemotherapy-induced nausea and vomiting (CINV).

The study was conducted at a single outpatient setting at Children’s Hospital, University of Colorado.

The patients were pediatric, in active treatment.

This was a randomized, double-blind, parallel group study.

• Complete response (CR) was defined as no episodes of vomiting and no use of rescue medication.
• Measurement instruments were patient diaries and Common Terminology for Adverse Events (CTAE).

• No serious, drug-related, adverse events were reported. Among those treated with aprepitant, the most common reported side effect was hiccups (15.6%).
• Comparison of response rates were, overall, 28.6% with aprepitant and 5.6% with controls.
• In the acute phase (0–24 hours), 60.7% with aprepitant had CR, compared to 38.9% in controls.
• In the delayed phase (24–120 hours), 35.7% with aprepitant had CR, compared to 5.6% in the control group.
• Analysis showed that the treatment difference in favor of the aprepitant triple therapy began at about 15 hours after chemotherapy administration.
• Pharmacokinetic analysis was compared to that previously done in adults and showed more variability in adolescents.

More patients in the aprepitant group achieved CR for CINV control in the acute and delayed phases, as well as in the overall study period. The addition of aprepitant to the antiemetic regimen appeared to be well tolerated in adolescents, with an overall adverse event profile similar to that seen in adults.

• The study had a small sample of less than 100 participants.
• The study was likely underpowered to demonstrate statistically significant results.
• The chemotherapeutic regimens were not described, so the emetogenicity was not clear and cannot be compared to other groups.
• The study was for a short period of only five days.
• The measure of CR was apparently based on patient diary results. Description of actual vomiting episodes was not provided, and compliance with diary recording was not described, although this is a method that is well known to be potentially problematic.
• Efficacy in terms of nausea was not discussed, as CR was defined only in terms of actual vomiting and use of rescue medication. No additional objective measure of the severity of nausea or vomiting was included.
• Statistical significance was not reported; only confidence intervals for findings were given.

Findings suggest that aprepitant in addition to standard antiemetic treatment is tolerable and may be helpful in patients between the ages of 11 and 19. Further study of the efficacy of antiemetic regimens in the pediatric and adolescent populations is warranted.