The study sought to assess the efficacy of relaxation training in reducing the incidence of hot flashes in women with primary breast cancer.

The intervention group received a single relaxation training session and was instructed to use practice tapes on a daily basis at home for one month; the control group received no intervention.

The study enrolled150 women from three breast cancer centers in England.

• Inclusion criteria: Postmenopausal women diagnosed with primary breast cancer and suffering from menopausal hot flashes. Any level of severity was accepted for inclusion in the trial as long as the women found the flashes to be troublesome. Postmenopausal was defined as six months without menstruation.

The study was a randomized controlled trial.

The incidence of flashes was measured using a diary, kept by the women, of every flash as it occurred over the period of one week. The women also gave a measure of the severity of each flash using four predefined categories: (a) length of flash, (b) physical manifestation, (c) emotional response, and (d) behavioral response. For each of these domains, four levels of severity (graded 1–4) were assigned, using the Hunter Menopause Scale.

Of 150 women recruited to the trial, 104 women completed it to the primary endpoint at one month, and 97 completed all three months. The incidence and severity of hot flashes, as recorded by diaries, significantly declined over one month (p < 0.001 and p < 0.01, respectively), compared with the control group. Distress caused by flashes also significantly declined in the treatment group over one month (p < 0.01), compared with the contro.l No significant differences between the treatment group and the control group at three months and no changes in anxiety or QOL were reported.

A large amount of attrition marred the trial.

To evaluate of the use of Biafine or Lipiderm to prevent radiodermatitis

Participants were randomized to one of three trial arms: Biafine, Lipiderm, or control (no prophylactic treatment). Study preparations were applied twice daily, starting 10 days prior to the beginning of radiation therapy and continuing until 10 days after treatment. Skin treatment was upgraded if necessary to steroids (grade 3 reaction), antibiotics (grade 4 reaction) or pause in therapy (grade 5 reaction).

• The study sample (N = 74) was comprised of female patients with breast cancer.
• Mean age was 69 years, with a range of 42–85 years.
• Of patients in the study, 63% were receiving concomitant tamoxifen.

The study took place at a single site.

The study used a randomized controlled trial design.

• The Radiation Therapy Oncology Group and European Organisation for the Research and Treatment of Cancer skin toxicity scale was used
• Overall treatment success was determined by maximal treatment grade, total number of radiation treatment gaps needed, the patients’ weekly impression, the radiotherapists clinical impression, and the study nurses’ impression.
• Impressions were measured by an evaluation questionnaire using the same criteria. Relevant data were reported as a grade of reaction.
• Pearson correlation, Chi-square or Fisher’s exact tests were used to analyze relationships among the three study arms.

• No objective data revealed an advantage in the Biafine or Lipiderm arm.
• The maximum skin treatment level was lower in the two intervention arms, but was not significant.
• Patients in both intervention arms reported a high level of satisfaction (Biafine 86% and Lipiderm 85%).

The study does not refute or support use of these products for an existing skin reaction and did not show a radioprotective effect.

• The study groups were too small to demonstrate any differences among study arms.
• Rubbing effects may have cause tissue damage.
• Radiation therapists, nurses, and patients were all responsible for granding, which affects the reliability of data.
• There was no mention of whether addition treatments were used as allowed.

To evaluate the use of Biafine or Lipiderm to prevent radiodermatitis.

Participants were randomized to one of three trial arms:  (a) Biafine, (b) Lipiderm, or the (c) control (no prophylactic treatment).

Study preparations were applied twice daily, staring 10 days prior to the beginning of radiation therapy (RT) and continuing until 10 days after treatment. Skin treatment was upgraded if necessary to steroids for grade 3 reaction antibiotics for grade 4 reactions or pause in therapy for grade 5 reactions.

• The sample was comprised of 74 women.
• Mean age was 69 years (range 42–85).
• Patients had T1-T2N0M0 breast cancer.
• Of the patients, 63% received concomitant tamoxifen.
• Patients with a complicated surgical wound or history of skin conditions were excluded.

Single site

The study was a randomized, controlled trial.

• The Radiation Therapy Oncology Group (RTOG) skin toxicity scale was used.
• Impressions were measured by an evaluation questionnaire using the same criteria. Relevant data were reported as a grade of reaction.
• Overall treatment success was determined by maximal treatment grade, total number of RT gaps needed, the patients’ weekly impressions, the radiotherapists' clinical impressions, and the study nurses’ impressions.
• Pearson correlation, chi-square, or Fisher exact tests were used to analyze the relationships between the three study arms.

• No objective data revealed an advantage in the Biafine or Lipiderm arms.
• Maximum skin treatment level was lower in the two intervention arms but was not significant.
• Patients in both intervention arms reported high levels of satisfaction (Biafine 86%, Lipiderm 85%).

The study neither refutes nor supports use of these products for existing reactions. These products did not show radioprotective effects.

• The study groups were too small to demonstrate any differences among study arms.
• Rubbing effects may have caused tissue damage.
• There were several responsible graders:  radiation therapist, nurses, and patients. Interrater reliability of the measurements was not addressed.

To study the effect of acupuncture on depression and insomnia in patients with malignant tumors. 

One time per day for 20 to 30 minutes, over a course of 30 days, patients in the intervention group received acupuncture on these acupoints:  Fenglon (ST-40), Yinlingquan (SP-9), Xuehai (SP-10), Sanyinjiao (SP-6), Yintant (EX-HN3), Baihui (DU-20), Sishencong (EX-HN1), Neiguan (PC-6), and Shenmen (TF-4). Patients in the control group received fluoxetine, 20 mg/day. Depression scores and sleep ratings were collected before and after the three-day treatment.

• The sample was comprised of 80 patients (66% male, 34% female) with malignant tumors:  40 patients were in the treatment group, which received acupuncture, and 40 were in the control group, which received 20 mg of fluoxetine daily.
• Mean age was 63.8 years (standard deviation [SD] = 5.47 years; range 18–75 years).
• All patients had a malignant tumor. Seven types of cancer were represented in the sample:  lung, gastric, breast, colorectal, lymphoma, cervical, and ovarian cancer. 
• Depression was assessed according to the Chinese Classification of Mental Disorders, third edition (CCMD-3).
• Patients with a functional disorder of the heart, liver, kidney, or spinal cord were excluded, as were those currently taking antidepressant medications.

• Single site
• Beijing, China

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial with intervention and control groups.

• Zung Self-Rating Depression Scale (SDS)    
• Hamilton Rating Scale for Depression (HRSD)
• Pittsburgh Sleep Quality Index (PSQI)

Pretreatment SDS scores of the treatment and control groups were 64.12 (SD = 5.34) and 64.24 (SD = 4.98), respectively, with no significant difference (p > 0.05). After treatment, SDS scores of the treatment and control groups were 43.64 (SD = 5.28) and 50.76 (SD = 5.42), which showed significant difference (p < 0.05). HRSD scores of both groups showed no significant difference before treatment (p > 0.05); however, after-treatment scores were 9.88 (SD = 1.27) in the treatment group and 13.72 (SD = 2.05) in the control group (p < 0.05). These results indicate that both acupuncture and fluoxetine were effective in reducing depression scores in these patients, with acupuncture showing greater effectiveness. PSQI scores of the treatment group, before and after treatment, were 14.48 (SD = 1.71) and 7.92 (SD = 1.22), respectively, with a significant difference (p < 0.001). The control group's PSQI scores, 13.92 (SD = 2.59) and 11.44 (SD = 1.89), did not reach significance (p > 0.05). Results indicate that acupuncture improved sleep quality in more patients than did fluoxetine.

Both acupuncture and fluoxetine were associated with reduced depression scores and some improvement in sleep. Due to the lack of a real control group and no control over cancer type and treatment phase, drawing a conclusion about the effectiveness of the intervention is difficult.

• The study had a small sample size, with less than 100 patients.
• The age range was small.
• The study was conducted at a single site, and the measurement tools were self-report instruments.
• Fluoxetine may take more than 30 days to reach therapeutic effectiveness.
• The study compared a fluoxetine-using group to an acupuncture-using group; the study included no real control group.
• The sample included diverse cancer types, and patients were at different phases of treatment. These factors may confound the findings.
• The authors did not analyze the differences between groups in regard to posttreatment PSQI scores. 
• The study did not include an attentional control or consider the possible placebo effect of acupuncture.
   

Acupuncture is a nonpharmacologic intervention that shows promise in reducing depression and improving sleep quality in patients with cancer and depression.

To study the efficacy of prophylactic antibiotics in pediatric patients with agranulocytosis and to investigate the efficacy and safety of different prophylactic protocols

Antibiotics included the combination of vancomycin and cefepime or single-use piperacillin/tazobactam. Control patients did not receive antibiotics prophylactically. Both groups were given oral voriconazole to prevent invasive fungal infections.

• N = 38  
• MEAN AGE: 8.3 years
• MALES: 63%, FEMALES: 37%
• KEY DISEASE CHARACTERISTICS: All had Acute myeloid leukemia (AML) and agranulocytosis after high-intensity chemotherapy

• SITE: Single-site    
• SETTING TYPE: Not specified    
• LOCATION: China

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Nonrandomized, observational trial

• Febrile events defined as a single-axillary temperature > 38.3° centigrade
• Cultures

There were no differences found between the two preventive protocols used. The prophylactic group had less frequent fever (p < .001), a longer interval to fever (p = .007), and an average of seven fewer hospital days (p < .001). Pulmonary and oral infection were most common. In the prophylactic group, three patients had diarrhea and one patient developed a rash. There were no other antibiotic-related side effects.

There were no differences found between the two preventive protocols used. The prophylactic group had less frequent fever (p < .001), a longer interval to fever (p = .007), and an average of seven fewer hospital days (p < .001). Pulmonary and oral infection were most common. In the prophylactic group, three patients had diarrhea and one patient developed a rash. There were no other antibiotic-related side effects.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Other limitations/explanation: The main outcome measure was a single episode of fever.

The findings showed that prophylactic antibiotics after high-intensity chemotherapy can be effective in children with minimal side effects. Findings should be considered with some caution given the study's limitations.

DATABASES USED: MEDLINE, CINAHL, British Nursing Index, EMBASE, AMED, PsycINFO, SIGLE, and CancerLit were searched, as well as Dissertation Abstracts International.

COMMENTS ON LITERATURE USED: From 1966–2002

FINAL NUMBER STUDIES INCLUDED = 8 RCTs, 10 reports

The most consistent effect was on anxiety. Only one reported an effect on depression.

Insufficient evidence

Databases searched were CENTRAL (Cochrane Library, Issue 1, 2002), MEDLINE (1966-May 2002), CINAHL (1982-April 2002), British Nursing Index (1994-April 2002), EMBASE (1980-week 25, 2002), AMED (1985-April, 2002), PsycINFO (1887-April, 2002), SIGLE (1980-March, 2002), CancerLit (1975-April, 2002), and Dissertation Abstracts International (1861-March, 2002). Reference lists of relevant articles were searched for additional studies.

Reviews were included if they

• Were randomized controlled trials (RCTs).
• Were controlled before-and-after studies or interrupted time-series studies.
• Studied aromatherapy or massage for patients with cancer.
• Measured changes in patient-reported levels of physical or psychological distress or quality of life (QOL) using reliable and valid tools.

• A total of 10 reports met inclusion criteria. Of these, 8 were RCTs, representing 357 patients.
• Most studies measured anxiety, depression, and pain; two demonstrated a reduction in nausea.

Two studies assessed the symptom of nausea. Both studies showed a reduction in nausea in hospitalized patients.

• Although the studies were RCTs, the sample sizes were small.
• Assessing the effect of aromatherapy was difficult because different essential oils were used.
• The degree to which variation in massage style affects outcomes is not known.

• Longer follow-up studies are needed with larger samples.
• No harm was involved, but evidence was mixed as to effect of aromatherapy enhancement to massage to a clinically significant level.

To evaluate the effectiveness of massage and aromatherapy for symptom relief in patients with cancer

The search used the following sources from 1966–2002: MEDLINE, CINAHL, British Nursing Index, EMBASE, AMED, PsycINFO, and CancerLit.

• A total of 1,322 references were initially retrieved.
• Two reviewers independently assessed trials for inclusion in the review, assessing study quality and extracted data.

Ten reports met the inclusion criteria; eight randomized controlled trials that included 357 patients were reviewed.

• The most consistently found effect of massage or aromatherapy massage was on anxiety.
• Four trials (207 patients total) detected a reduction in anxiety postintervention.
• There was no reported decrease in anxiety with the addition of aromatherapy.

While there is sufficient evidence to support the effectiveness of massage in decreasing anxiety in patients with cancer, there is insufficient evidence to draw conclusions about the effectiveness of aromatherapy massage for patients with cancer. Further research is needed.

To examine the effects of a palliative rehabilitation program on depression, and explore the impacts and interactions between depression, inflammation, exercise, and self-efficacy.

All patients received group physiotherapy twice a week; all patients also received as treatment plan based on assessment of individual functioning and goals that was implemented during the course of the study, including support, encouragement, feedback, and guidance to motivate patients and encourage positive change. The program was provided during an eight-week period. Study measures were obtained at baseline and at the completion of the program.

• N = 80
• AGE = Not provided
• MALES: 47.5%, FEMALES: 52.5%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types existed. Patients were in stage III or IV. Breast and hematological cancers were most common.
• OTHER KEY SAMPLE CHARACTERISTICS: ECOG status of 2 or better. 21.3% were taking antidepressants.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Ottawa, Canada

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care

• Quasi-experimental

• C-reactive protein (CRP) as a marker of inflammation
• Six-minute walk test (6MWT)
• General Self-Efficacy Scale
• Hospital Anxiety and Depression Scale (HADS)

Completion rate for sessions was 69%. There was no change in CRP. Performance on the 6MWT increased (p < 0.001). Self-efficacy scores increased from a mean of 27.86 to 31.23 (p <  0.01). Depression scores decreased on average from 7.14 to 5.95 (p = 0.002).  Analysis showed that exercise results and self-efficacy were significant predictors of change in depression scores. Changes in the 6MWT explained 3% of the change in depression and self-efficacy explained 11%.

The multicomponent rehabilitative intervention tested here was associated with reduced depression scores. Exercise and self-efficacy were shown to be significant predictors of depression scores.

• Small sample (less than 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Subject withdrawals of 10% or greater 
• Almost 50% who entered the study did not complete it; about half of these were due to disease progression.
• Authors state that use of antidepressants was not correlated with change in depression scores; however, it would not necessarily be expected that scores would decline further, and there was no subgroup analysis based on use of antidepressants.
• The measure used for exercise was a measure of stamina, not exercise intensity or regularity, so their conclusions that exercise may not be as effective for depression is not necessarily accurate.
• Mean depression score changes were not at a level that was clinically significant, and floor effects of the measure at baseline are possible.
• It is not known if participants were doing any other interventions for support.

Participation in exercise has been associated with improvement in depressive symptoms, and exercising in a group setting may enhance support and its effects on self-efficacy and mood. Findings of this study, however, showed statistically significant changes in depression, but the size of these changes on the measures used was not clinically significant. Research in this area should be aimed at individuals who have clinically relevant depressive symptoms.

STUDY PURPOSE: To assess the effect of low level laser therapy (LLLT) for oral mucositis

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 24
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,383
• SAMPLE RANGE ACROSS STUDIES: 1–221 patients
• KEY SAMPLE CHARACTERISTICS: Patients who have had hematopoietic cell transplantation (HCT), patients with head and neck cancer receiving chemotherapy and radiation therapy, patients with other tumor types receiving chemotherapy, and two studies including pediatric cases

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Pediatrics

Most evidence showed a positive effect of LLLT on oral mucositis in delayed time of onset, lower peak severity, and shortened duration. One study in children showed no benefit of LLLT when optimal dental and oral care were provided.

LLLT is beneficial for the management of oral mucositis; however, ideal wavelengths, timing, and frequency of treatment are unclear.

• Limited search
• No study quality evaluation

LLLT has been shown to be effective in reducing the symptoms of oral mucositis in patients undergoing transplantation and those receiving treatment for head and neck cancer. The specifics for optimal LLLT timing, duration, and so forth have not been determined. Further research on these aspects is needed.