To determine the optimal single-dose radiotherapy schedule for pain related to bone metastases

Patients were randomly assigned to receive a single dose of 8 Gy, a single dose of 4 Gy, or 12 Gy in four fractions given over two consecutive days. Additional treatment with 8 Gy was given if moderate or severe pain persisted. Analgesic use was documented at baseline and at each follow-up. Patients were assessed at baseline and at four, eight, 12, 24, and 52 weeks.

• N = 545 at week 4  
• MEDIAN AGE = 57 years (range = 25–88 years)
• MALES: Not provided, FEMALES: Not provided
• KEY DISEASE CHARACTERISTICS: Multiple tumor types; metastasis sites were spine, pelvis, hip, femur, humerus, and other sites
• OTHER KEY SAMPLE CHARACTERISTICS: About 21% of patients were not receiving any analgesics at baseline, and 34% were receiving strong opioids.

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

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

Randomized trial

• 10 cm Visual Analog Scale (VAS) for pain
• Four-point scale for pain (0 = none, and 4 = severe)
• Complete response (CR) was defined as no pain and a score of 0 on the VAS. Partial response (PR) was defined as a reduction of one point on the four-point scale or a VAS reduction of at least 10 mm.

Across all follow-up time points, the proportion of those with CR and PR was higher with radiotherapy at 8 Gy although the difference between the groups was only significant at eight weeks. More treatments were needed with 4 Gy radiotherapy (p = 0.01). The response rate with 8 Gy was 70%–80% at four weeks compared to 82% with 4 Gy.

A single dose of 8 Gy radiotherapy was associated with higher CR rates, and a dosage of 4 Gy was effective in a substantial number of patients.

• Risk of bias (no blinding)
• Measurement/methods not well described 
• Other limitations/explanation: How pain data was collected was not stated. No information was provided on any changes in analgesics or the use of bone modifying agents.

Both single-dose 4 Gy and 8 Gy radiotherapy were effective in reducing pain in the majority of patients. An 8 Gy dosing was beneficial in a higher proportion of patients, and fewer patients at this dose required additional treatment. Individual patient variables need to be considered in determining dosages based on tolerance and concerns about toxicity.

To compare a single, intravenous infusion of ibandronate with single-dose radiotherapy for metastatic bone pain

Patients referred for pain management were randomized to receive 6 mg ibandronate or a single dose of 8 Gy radiotherapy. Patients whose pain failed to respond to the treatment at four weeks were allowed to cross over to the opposite treatment within four to eight weeks. Assessments were done at baseline and at four, eight, 12, 26, and 52 weeks.

• N = 470
• MEDIAN AGE = 72.5 years (range = 47–97 years)
• MALES: 100%
• KEY DISEASE CHARACTERISTICS: All had prostate cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients who had previous treatment with radiotherapy or bisphosphonates within the last six months were excluded. Overall, 90% were receiving hormone therapy. The baseline median pain score was 7.

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

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

Randomized noninferiority trial

• World Health Organization (WHO) criteria for analgesia
• Morphine equivalents for analgesia use
• Brief Pain Inventory (BPI)
• Effective Analgesic Score (EAS)
• Functional Assessment of Chronic Illness Therapy (FACIT) for quality of life
• Complete response was defined as a pain score of 0 with stable or reduced analgesic use.
• Partial response was defined as a two-point reduction in pain scores or a 25% reduction in analgesia with a stable pain score.

Overall, 31% of participants who began with ibandronate were crossed over, and 24% who began with radiotherapy were crossed over. There was no difference in WHO worst pain response between the groups at any study assessment period. There were no differences between the groups in worst pain response. At four weeks, those receiving radiotherapy had better responses (p = 0.04), but there was no difference at 12 weeks. There were no differences in quality of life between groups. Twice as many patients in the radiotherapy group had diarrhea (p = 0.014), and more had nausea (p = 0.058).

Single-dose radiotherapy and a single infusion of ibandronate had similar results on pain caused by bone metastases in men with prostate cancer. Radiotherapy was associated with more short-term adverse effects.

• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Other limitations/explanation: No information was provided regarding analgesics used, and data regarding any changes in analgesia were not provided.

This study showed similar results for pain reduction with single-dose radiotherapy and a single infusion of ibandronate. Ibandronate is a newer bone modifying agent, so it is not clear if all bone modifying agents would provide equivalent results in comparison to radiotherapy. Bone modifying agents may have fewer side effects, which can be of importance depending upon the site of radiotherapy.

To evaluate the effect of epoetin alfa on local disease-free survival (DFS) (primary endpoint), overall survival, and cancer treatment-related anemia and fatigue (secondary endpoint).

Patients were randomized to one of the following three groups:

• Radiation and epoetin alfa 10,0000 units subcutaneously (subq) if hemoglobin (Hgb) was less than 15 g/dL
• Radiation and epoetin alfa 4,000 units subq if Hgb was less than 12.5 g/dL
• Radiation alone.

• The study included 300 patients (232 men, 68 women); 111 completed the study.
• Age ranged from 35 to 88 years.
• Patients were diagnosed with squamous cell head and neck cancer, stages I to III.
• Patients had a Hgb level less than 15 g/dL.

• Multisite
• United Kingdom

The study was a phase III, randomized, controlled trial.

• Functional Assessment of Cancer Therapy-Anemia (FACT-An)
• FACT-Head and Neck

Hgb increased from baseline with epoetin alfa. Median duration of local DFS (primary endpoint) was not statistically significant (hazard ratio = 1.04). The groups did not differ significantly in terms of DFS, overall survival, tumor outcomes, or cancer-related anemia or fatigue.

The addition of epoetin alfa did not affect survival, tumor outcomes, anemia, or fatigue positively or negatively in the head and neck cancer population.

• The study had low accrual.
• The degree of diagnostic severity, combined with the effects of radiation, may have minimized the potential benefit of epoetin alfa.

Epoetin alfa cannot be recommended for the treatment of cancer-related fatigue in the head and neck cancer population.

The overall purpose of the study was to examine sudden improvements in the symptoms of depressed patients with cancer who were receiving brief (nine-session) behavioral activation therapy (BAT). Specificially, the study examined the the frequency of sudden gains, the relation of sudden gains to the intervention components, the association of sudden gains to clinical and demographic variables, and the relation of sudden gains to treatment response and maintenance at three-month follow-up.  

Authors recruited study participants by means of medical clinic screenings at the University of Tennessee Medical Center Cancer Institute. Participants provided informed consent and were included if they scored 9 or higher on the Harvard Department of Psychiatry National Depression Screening (HANDS) scale and met inclusion criteria following completion of a pretreatment diagnostic assessment battery (see instruments below). Inclusion criteria consisted of being diagnosed with cancer at age 18 or older, having a primary diagnosis of major depression with moderate to severe symptoms, and not being psychotic or cognitively impaired. After developing rapport with each particpant, the therapy provider assessed the function of depressed behavior and introduced the treatment rationale. Rationale included to reduce reinforcement of depressed behavior, increase healthy behavior, or increase exposure to reinforcement of healthy behavior. Provider and patient discussed a behavioral checklist form each week, in the one-hour psychoeducation session. The provider presented the treatment rationale and facilitated activity and goal selection and behavioral activation. Examples of activities and goals included engaging in weekly self-monitoring of daily activities, providing baseline measurement, and identifying potential activities to target during BAT. Patients prioritized activities and values, and they set goals from easy to difficult, with the aim of working upward in this hierarchy: family, peer, intimate relationships, education, employment, career, hobbies, recreation, volunteer work, charity, physical, health issues, and spirituality.

• The sample was composed of 26 patients. In the group with sudden gains, mean age was 54.5 years. Mean age in the group without sudden gains was 51.2 years.
• Males: 8%; females: 92%.
• Of the 26 participants, 10 had coexistent diagnoses of generalized anxiety disorder, social phobia, panic disorder, post-traumatic stress disorder, or specific phobia. Cancer types were breast, lung, stomach, colon, prostate, and pancreatic. Average time since diagnosis was two years.

• Single site
• Outpatient
• University of Tennessee Medical Center Cancer Institute medical clinics
   

• Phase of care: active treatment
• Clinical applications: late effects and survivorship

Pre/post-test time-series measurements

• Anxiety Disorders Interview Schedule (ADIS-IV)    
• Beck Depression Inventory-II (BDI-II)
• Hamilton Rating Scale for Depression-24 (HRSD)
• Beck Anxiety Inventory-II (BAI-II)
• Medical Outcomes Study 36-item Short-Form 36 Health Survey (SF-36)
• Multidimensional Scale of Perceived Social Support (MSPSS)
   

During the treatment 50% of participants experienced sudden gains as measured by an average of 11.8 BDI-II points. None experienced more than one sudden gain. Four participants exhibited reversals following sudden gains; all four returned to within 50% of their sudden gain in the post-treatment assessment. The initial scores of participants who experienced sudden gains had less-severe depression as measured by the pretreatment ADIS-IV. Those who made sudden gains in measures related to emotional problems, as measured by the SF-36 subscales, reported greater physical functioning, less bodily pain, and fewer problems with work and daily activities. Authors found no between-group differences regarding demographic and cancer-related variables. Compared to those without sudden gains, patients with sudden gains had significantly lower HRSD post-treatment scores. However, “as a follow-up to the finding that decreased depression severity was associated with sudden gains, the relationship of depression severity and sudden gains in treatment responders was evaluated. ... [D]epression severity did not differ as a function of sudden gain status at post-treatment but was marginally significant at 3-month follow-up . . . with those experiencing sudden gains exhibiting a trend for lower pre-treatment depression severity ratings relative” to responders who did not report sudden gains.

Authors noted that 50% of depressed patients with cancer who had received BAT experienced a sudden gain. Findings suggest that, in regard to depression treatment in patients with cancer, a streamlined and parsimonious behavioral activation approach is as adequate as a more comprehensive cognitive-behavioral approach.

• The study had a small sample size, with fewer than 30 participants.
• The study included no ethnic diversity, and participants consisted primarily of breast cancer patients. These factors may affect generalizability.

Nurses treating depressed patients with cancer are advised to consider the role of increased pain and physical functioning in preventing sudden gains and other desirable treatment responses.  Nurses who assimilate this knowledge into treatment plans may provide better care to depressed patients with cancer than do nurses who do not.

To examine efficacy of eight weeks of behavioral activation and problem-solving therapies toward reducing depression and suicidal ideation

Patients who had breast cancer and met the Harvard National Depression scale criteria for symptoms of major depression were randomized to behavioral activation or problem-solving psychotherapy interventions. Sessions were provided by clinical psychology doctoral students who were skilled in both interventions. All sessions were one on one and audiotaped, and 15% of tapes were randomly selected for review of competence and adherence by an independent therapist.

• N = 80 in ITT analysis, 65 completed treatment  
• MEAN AGE: 55.4 years (SD = 11.9 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; average time since diagnosis was 3.2 years
• OTHER KEY SAMPLE CHARACTERISTICS: 43% had prior psychotherapy and, on average, had moderate level depression and mild to moderate suicidal ideation at baseline; 93% were Caucasian; and research included people taking antidepressants, but the number of those on antidepressants was not reported.

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: New York, NY

PHASE OF CARE: Transition phase after active treatment

• Randomized trial

• Hamilton Rating Scale for Depression (HRSD) 
• Beck Depression Inventory (BDI)
• Center for Epidemiological Studies Depression scale (CES-D)

For all measures, there was a significant main effect for time (p < 0.05), showing decline in depression; but there were no differences between groups. There was a significant linear reduction in suicidal ideation and an increase in hopefulness at post-treatment and at the 12-month follow-up.

Both types of psychotherapy examined here were associated with reduced depression and suicidal ideation.

• Small sample (less than 100)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Subject withdrawals of 10% or greater 
• Proportion of the sample on antidepressants is not described, and there is no subgroup analysis of outcomes between those on or not on antidepressants

Psychotherapy can be helpful for patients with cancer who also suffer from depression and may have suicidal ideation. This study adds to the body of evidence on efficacy of psychotherapy for these patients. Psychotherapy should be considered as part of treatment options for individuals who have clinically relevant depression or a major depressive disorder.

To test the efficacy of behavioral activation for depression therapy (BADT) compared to problem-solving therapy (PST) in depressed breast cancer patients

Patients were randomly assigned to either BADT or PST. Each therapy was delivered in individual sessions over eight weeks. In the BADT group, patients engaged in self-monitoring exercises and identified the level of reward or pleasure for behaviors and activities. Then researchers emphasized identifying values and goals within multiple life areas and targeting behaviors for attention. The patient and therapist collaboratively set goals and activities each week, and patients progressed through activities, from easiest to hardest, aimed at reducing aversive experiences. Sessions included muscle relaxation, assertiveness training, and graduated exposure to anxiety-producing stimuli. PST involved therapy to increase patients' understanding of the connection between current depression and anxiety symptoms with everyday problems, to help patients define current problems, and to teach patients a specific problem-solving method. Therapists were experienced in providing the intervention they delivered. Sessions were recorded, and a 15% sample was independently evaluated to assess fidelity of the intervention. The principal investigator supervised all therapists weekly and individually.

• The sample was composed of 65 patients with breast cancer (100% female).
• Mean patient age was 55.4 years (SD = ±11.9 years).
• Average time since diagnosis was 3.1 years.
• Most patients had stage 0–II disease; 95% had had surgery, 74% had had chemotherapy, and 64% had had radiation therapy; 52% were currently taking antidepressants.
• Approximately 42% were working either full- or part-time.
• All patients had to meet screening criteria that demonstrate a diagnosis of major depression of at least moderate severity.

• Outpatient settings, specific sites unstated or unknown 
• Tennessee and Maryland

Late effects and survivorship

Randomized controlled trial design

• Beck Depression Inventory (BDI)
• Environmental Reward Observation Scale (EROS)
• Beck Anxiety Inventory (BAI)
• Quality of Life Inventory (QOLI)
• 36-item Short-Form Health Survey (SF-36)
• Multidimensional Scale of Perceived Social Support (MSPSS)
• Hamilton Rating Scale for Depression (HRSD)

BDI and HRSD sales demonstrated significant improvement in depression (p = 0.04). Mental health and general health scales on the SF-36 also improved (p = 0.02). Results revealed no significant difference between groups, and both interventions demonstrated a strong effect size.

Findings demonstrate that both the BADT and PST interventions were effective in reducing depression in the groups of patients studied.

• The study had a small sample size, with fewer than 100 participants.
• The study had risk of bias due to no blinding.
• Of all participants, 19% dropped out. Authors had determined sample size to accommodate this, given previous research.
• Findings relate to patients with major depression and may not relate to patients with symptoms of depression that is less severe than major depression.

Findings show that both of the interventions were effective in reducing the level of depression among patients with breast cancer with major depression. The drop-out rate over the eight-week study period suggests that participating in the target intervention may be difficult or impractical for many patients.

To assess, in a medical care setting, the effectiveness of a brief cognitive behavioral treatment for depression on depressed patients with cancer

• Patients were screened for depression; researchers administered the Anxiety Disorders Interview Schedule-IV (ADIS-IV) to eligible participants and considered all self-report measures.
• Participants completed nine-week one-on-one cognitive behavior therapy for depression. Sessions were weekly. The same clinical graduate student assessed and treated all patients.
• Variables were examined pretreatment, post-treatment, and at three months after the therapy.

• The study reported on a sample of 13 patients (11 females, 2 males).
• Mean patient age was 52.2 years (SD = 10.9 years).
• Tumor-type distribution was breast (n = 7), lung (n = 1), stomach (n = 1), colon (n = 1), prostate (n = 1), pancreatic (n = 1), and bone cancer (n = 1); all had stage I or II cancer.
• All participants were Caucasian. The average length of education was 14.8 years.
• Mean level of major depression was 5.7 (SD = 1.1), suggesting moderate clinical depression.
• Average time since diagnosis was 1.5 years; three participants were actively on treatment. Coexistent diagnoses included generalized anxiety disorder (n = 7), social phobia (n = 3), panic disorder (n = 1), obsessive compulsive disorder (n = 1), specific phobia (n = 1), and anxiety disorder not specified (n = 1).
• Participants were included if not on antidepressants or antianxiety medications or if stabilized for eight weeks on consistent dose prior to study assessment.

• Single site
• Outpatient setting
• Cancer institute in Tennessee

Patients were undergoing the active treatment and transition phases of care.

A pre/post-test, convenience sample design was used.

• Harvard Department of Psychiatry National Depression Screening (HANDS) scale
• 10-item Anxiety Disorders Interview Schedule–IV (ADIS-IV)
• Hamilton Rating Scale for Depression (HRSD), a 24-item semistructured interview designed to measure symptom severity
• Beck Depression Inventory–II (BDI-II)
• Center for Epidemiological Studies of Depression Scale (CESD), a 20-item self-report questionnaire regarding symptoms of depression
• Beck Anxiety Inventory (BAI), a 21-item questionnaire designed to distinguish cognitive and somatic symptoms of anxiety
• Quality of Life Inventory (QOLI), a 16-item self-report measuring life satisfaction across a range of domains
• Medical Outcomes Study Short Form–36 (SF-36)
• Multidimensional Scale of Perceived Social Support, a 12-item scale that assesses adequacy of social support
• Client satisfaction questionnaire

• Patients completed an average of 118.9 (SD = 49.8) assigned activities, resulting in an overall patient adherence score of 82%. Post hoc analysis showed significant pre- and post-treatment improvement on measures of depression, anxiety, quality of life, and medical outcomes; improvements were clinically significant as indicated by moderate-to-large effect sizes (R = 0.6 to 2.0).
• All treatment gains were maintained at three-month follow-up. Somatic anxiety did increase slightly at follow-up.
• Patients were strongly satisfied with cognitive behavior therapy for depression.
• All patients improved significantly on the RCI, and all but one patient (92% of total) improved on the BDI and HRSD.
• 54% of patients demonstrated statistically significant improvement in somatic anxiety, according to the BAI, and 62% reported increased quality of life as measured by the QOLI.
• The SF-36 showed significant clinical change as follows: physical functioning (62%), mental health (62%), role emotional (54%), role physical (54%), general health (62%), bodily pain (54%), vitality (69%), and social functioning (62%).

Behavioral therapy interventions, especially when paired with cognitive techniques, may represent a practical medical care treatment to improve psychological outcomes for and quality of life of patients with cancer.

• The study had a small sample size, with less than 30 participants.
• The study lacked randomization, had no control group, included one site, and provided no assessment of anxiety symptoms and disorders and their relation to outcome.
• The study lacked multiple-baseline design.
• Longer-term follow-up is needed.
• A clinical graduate student was used instead of an experienced therapist.
• A comprehensive protocol was not used for the interview.

Depression is a major concern for patients with cancer. To identify patients who need treatment, tools should be developed that are more nurse-friendly and easier to administer.

To review patient–family psychosocial interventions in cancer care on physical, psychological, social, and quality-of-life effects

To evaluate associated theoretical models and measured effects

• Databases used in the search were MEDLINE, EMBASE, PsycINFO, and CINAHL.
• Keywords were cancer, systematic, review, couple, family, psychosocial intervention, symptom, and quality of life.
• Inclusion criteria: English-language adults with cancer (18 years or older) from resource-rich countries; family/couples/partners (all gender combinations); relationship of caregiving between patient and other(s); illness-related (not long-term relationship) problems; studies with experimental design (e.g., randomized controlled trial [RCT], case control, systematic review); nonpharmacologic interventions; illness-related disruption in relationships and/or illness-related conflict; and evaluation of an outcome (e.g., satisfaction, distress, quality of life, pain)
• Exclusion criteria: Teenagers and children; people in residential care and other institutions where primary carers are professionals; pharmacologic interventions; intervention that cannot be delivered in a community setting (i.e., patient’s home); non-Western culture; intervention that is targeted at long-standing family dysfunction; intervention that is delivered over a long period of time (more than 2.5 months); intervention where the effect is not expected for longer than 2.5 months; study of past cause of family dysfunction; study of future prevention of family dysfunction; nonillness-related family problems; care/support/intervention for carer independent of patient (e.g., management of carer problem); care/support/intervention for patient independent of carer (e.g., management of patient problem); patient–healthcare professional relationships; carer–healthcare professional relationships; education or support for healthcare professionals; and organization/delivery of a service

• A total of 80 references were retrieved.
• One author performed a title and abstract scan on each retrieved study. The second author reviewed 10% of studies for reliability.
• Disagreements were resolved through discussion.

• A final number of 27 studies were included in the review.
• Sample range across studies was 14–480.
• Of the 27 studies (published between 1999 and 2009), 22 interventions focused on patients and family caregiver (dyad focus; too few studies focused on a multi-member family unit were found to include).
• Sample studies included patients with early-stage breast, gynecologic, and prostate cancers; all stage central nervous system tumors; and cancer-related pain; as well as patients undergoing chemotherapy.

• Active antitumor treatment phase   
• Elder care; palliative care

Dyad-focused nonpharmacologic interventions may improve coping and emotional support. High attrition related to the practical burdens associated with trial participation and care of a seriously ill patient impact the design and conduct of RCTs to test these interventions, but adverse events are few. Interventions that promote interactions within the dyad are more likely to have a measurable effect on emotional health outcomes than those targeted to a single member of the pair. Few studies are theory-based.

Dyadic interventions that promote interaction appear to be beneficial to impact anxiety, depression, and distress in patients with cancer and the family members who care for them.

The review was limited to English language studies.

High attrition rates in studies imply that it is important to match the intensity/complexity of an intervention with the dyad’s ability/willingness to participate fully, or risk drop out. Further theory development and testing are needed to guide design and conduct of future studies in this area.

To explore the current state of the science regarding acupuncture as a treatment modality for cancer pain

TYPE OF STUDY: Systematic review

Databases searched were PUBMED and CINAHL, in addition to websites from the National Cancer Institute, the National Institute of Health's Complementary and Alternative Medicine Program, and the American Cancer Society.

Keywords were acupuncture for cancer pain and cancer pain management acupuncture.

Studies that focused on cancer pain and acupuncture using human participants, were English language, and described attitudes associated with acupuncture or complementary and alternative medicine were included in the search.

Studies that focused on postoperative pain and studies that combined acupuncture with other modalities, such as massage, were excluded from the search.

A total of 130 studies from  2000 to 2009 were retrieved.

• A final number of 11 studies were included in the review.
• The 11 studies included 3 randomized controlled trials, 1 pilot study, 1 meta-analysis, 1 case-control study, 1 prospective cohort study, and 4 expert reviews.

• Level I evidence: The administration of true acupuncture resulted in decreased pain when compared to the sham acupuncture and the control group (p < 0.05). No long-term difference in pain improvement was noted among groups.
• Level III evidence: The low statistical power of this study and the lack of attempts to control for confounding variables affected the external validity.
• Level V evidence: A decrease in pain was reported at one month for 16 of the 34 patients treated with acupuncture (p < 0.05) and at the six-month follow-up for 14 of the 34 patients treated with acupuncture (p < 0.05).

The use of acupuncture as a complementary treatment for the management of cancer pain may have the potential to improve the quality of life of patients with cancer. Benefits of the addition of acupuncture for cancer pain management must be supported by evidence of safety and effectiveness. A synthesis of the current evidence reveals a lack of level I and level II studies pertaining to acupuncture as an intervention for the management of cancer pain. The nonexperimental studies cannot adequately infer causality.

To test the hypothesis that the use of aloe would lead to a one-point reduction in radiation-induced skin rash (RISR) severity and a decrease in symptom severity compared to a traditional dry powder skin care regimen

Potentially eligible patients underwent a skin test to rule out allergic reactions. Informed consent was obtained, and patients were randomized to each arm (aloe, placebo cream, or control powder). The creams were dispensed in identically labeled containers to the patients with study protocol directions. Two radiation oncology nurses trained to identify RISR assessed acute skin reactions and completed scoring at weeks 1, 2, and 4. All patients were asked to either use no soap or mild soap and to apply baby powder or cornstarch to the treatment skin markings. Patients in the powder arm applied powder during treatment followed by one month of a moisturizing cream. Those in the cream arm applied it three times per day throughout treatment and for one month after completion. Additional treatment for moist desquamation and other skin reactions was administered according to individual physician preferences.

• N = 237
• AGE = > 18 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Nonmetastatic breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Previous mastectomy or segmented resection; agreement to comply with the study protocol; received either 45 Gy in 20 fractions or 50 Gy in 25 fractions; approximately 40% were current smokers

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: Canada

• PHASE OF CARE: Active antitumor treatment

Single-blinded, placebo-controlled, randomized trial

• Modified 10-point Catterall skin scoring profile

Patients were studied during a 21-month period. Ten withdrew before the start of the study, and one withdrew because of a selection error. Skin rashes occurred in all three arms with the greatest number of skin rashes noted in the aloe cream arm (31% compared to 15.6% with a placebo). Skin reaction scores were consistently higher with aloe than with the standard treatment of powder (p < 0.02). The study also showed that patients in the powder arm reported more dryness, pain, and itching (p = 0.0163). This study did not meet the endpoint of a change in the RISR severity of one point. Women with breast cup sizes C and greater experienced a significantly higher severity of skin reactions (p < 0.02). It also was noted that erythema and dry desquamation occurred more with powder, and moist desquamation (< 50%) occurred most with aloe cream and (> 50%) occurred most with powder.

The results of the study showed that known-quality aloe or placebo creams did not improve skin reactions or symptoms; they made them worse. The study also concluded that dry skin was better than moist treatment during radiation treatment.

• Baseline sample/group differences of import
• Measurement/methods not well described
• Other limitations/explanation: The treatment of moist desquamation was not standardized, so physicians could order whatever was deemed medically necessary. The study did not disclose whether any of the study patients fell into that category. A significantly higher proportion of patients in the aloe and placebo arms received chemotherapy as well. It appears that radiation therapy did not employ intensity-modulated radiation therapy. The use of powder on the skin is not common as a standard of practice.

Patient education is very important, and patients should be instructed to use only skin care products that will be effective in managing radiodermatitis. This study had some limitations, but it adds to the growing body of evidence that aloe can make radiation skin reactions worse. Patients should be instructed to not use aloe products on their skin.