96915.pdf

Study Purpose

To evaluate a cream containing melatonin in terms of efficacy in reducing acute radiation dermatitis during and immediately after radiation therapy, and to examine patient-reported comfort during the study period

Intervention Characteristics/Basic Study Process

Patients were randomized to either the melatonin cream or placebo (same emulsion without melatonin) and instructed to apply the cream twice daily on the treated (irradiated) breast during five weeks of radiation treatment. Patients were instructed not to use any other products on the treated breast during radiation and to apply the cream up until two hours before receiving radiation. Both patients and physicians completed questionnaires when radiation began, weekly during the treatment, and at the two-week follow-up visit. Physician questionnaires involved grading the skin toxicity of the treated breast. Patient questionnaires addressed their ratings on pain, dryness, and itching of the treated breast.

Sample Characteristics

N = 47, 26 in melatonin group and 21 in placebo group
AGE = Older than age 18 years
MEDIAN AGE = 54–55 years
FEMALES: 100%
CURRENT TREATMENT: Radiation
KEY DISEASE CHARACTERISTICS: Stage 0–II breast cancer
OTHER KEY SAMPLE CHARACTERISTICS: Status postlumpectomy; no prior radiation to the chest or breast; most patients had fair skin and a body mass index of 24; total radiation dose, 50 Gy, was given as a daily fraction of 2 Gy; patients on 3-D treatment plans; the boost area was not evaluated (additional 10 Gy and 16 Gy); patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; smoker status

Setting

SITE: Single institution
SETTING TYPE: Not specified
LOCATION: Sheba Medical Center in Tel Aviv, Israel

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Phase II, prospective, double-blind, randomized

Measurement Instruments/Methods

Radiation Therapy Oncology Group (RTOG) toxicity score
Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, acute toxicity scoring criteria
Questionnaires
Likert-type scale

Results

The researchers reported no significant difference in skin toxicity for both groups for the first four weeks of radiation treatment. The authors reported findings of significance in terms of reduced radiation dermatitis in the melatonin group at week five to seven (p = 0.049). After radiation was complete, the authors reported significant findings at the two-week follow-up visit in terms of reduced dermatitis in the melatonin group (p = 0.03). The researchers found no difference in the melatonin group and placebo group patient questionnaire reports of symptoms during treatment (including pain, burning, itching). Other analysis showed that women in the melatonin group who were older and smoked showed less radiation dermatitis (significance values p = 0.021 and p = 0.007). Four patients in the melatonin group sustained an allergic reaction limited to the treated skin, which required treatment with a topical and/or oral steroid.

Conclusions

Women with early stage breast cancer (stage 0–II) who are status postlumpectomy and undergoing daily radiation treatment for five weeks may experience reduced skin toxicity from the twice daily application of a melatonin containing cream to the treatment area.

Limitations

Key sample group differences that could influence results
Authors identified that their patient sample was comprised of women with a body mass index of 24 and that other patients with higher body mass indexes (i.e., including obese patients) may influence the findings.
Intervention expensive, impractical, or training needs (was not able to find the cost of the product Praevoskin; unsure if Pharm-Olam, the company that supported/funded this study, is the manufacturer of this product or not; also unclear if other melatonin-containing products would be as useful in reducing the amount of radiation dermatitis)
Fairly small sample size with patient median age of 54–55 years
Unclear if results would vary with younger and older patients (e.g., younger than age 45 years or older than age 65 years)

Nursing Implications

As there is currently no consensus or evidence-based practice to follow for the treatment for radiation dermatitis, this study could be used to identify a treatment option and possibly specific product use in other institutions where radiation is delivered. Although this study was limited to women with breast cancer who had undergone lumpectomy, there could be utility in applying the melatonin cream to patients undergoing radiation therapy for other types of cancers (e.g., head and neck cancer).