Fenton-Kerimian, M., Cartwright, F., Peat, E., Florentino, R., Maisonet, O., Budin, W., . . . Formenti, S. (2015). Optimal topical agent for radiation dermatitis during breast radiotherapy: A pilot study. Clinical Journal of Oncology Nursing, 19, 451–455. 

To assess which of the three topical emollients commonly used for the skin care of patients undergoing whole breast radiation therapy minimizes the grade of dermatitis and cost of product, and to evaluate their effect on quality of life.

A total of 30 patients were randomized to three groups of 10 patients each and received one of three different skin care products to apply during radiation therapy to the whole breast (Calendula cream twice daily, RadiaPlex (hydrogel cream) twice daily, or mometasone twice weekly during the first and second weeks of radiation and daily during week three, plus Aquaphor daily). Weekly skin evaluations were conducted by a medical doctor or a nurse practitioner and RN. Another skin assessment was conducted at one week, one month, and three months post radiation therapy. Life quality index forms were completed by the patients at during visits.

• N = 30   
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Women with stage I–II node-negative breast cancer. Post lumpectomy or partial mastectomy with negative margins. At least two weeks post breast surgery.
• OTHER KEY SAMPLE CHARACTERISTICS: Patients who were scheduled to receive 4256 cGy to the whole breast in 16 fractions. Patients were excluded if they were undergoing concomitant chemotherapy or were less than two weeks post chemotherapy. Other exclusion criteria included patients with connective tissue disorders, such as lupus or rheumatoid arthritis.

• SITE: Single site    
• SETTING TYPE: Not specified  
• LOCATION: New York University (NYU) Clinical Cancer Center

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial using three commonly used topical emollients

Weekly skin assessment by a medical doctor or a nurse practitioner and RN at one-week follow-up, one-month follow-up, and three-month follow-up visits. Completion of a Dermatology Life Quality Index (DLQI) (visual analog survey) or DLQI upon enrollment to study, during enrollment, and after radiation.

Skin assessment findings and quality of life index scores showed no significant difference based on the product used. All patients experienced grade 1–2 (maximum) dermatitis. Patients did not report a significant decline in their quality of life scores based on the amount of radiation dermatitis they experienced. The maximum grade of dermatitis occurred the first week after completing treatment. Time to maximum skin reaction and time to resolution of the skin reaction for each of the three study arms were equal. A difference in cost existed between the three products (the Calendula cream was the least expensive at approximately $11 per 6.7 oz tube, the mometasone was approximately $48 per unknown dose size, and the RadiaPlex was the most expensive agent at $59 per 6 oz tube).

In this small pilot study, no significant difference was observed between three commonly used topical emollients on the occurrence or severity of radiation dermatitis among patients undergoing whole breast radiation. A cost difference existed between the three products.

• Small sample (< 30)
• After equivocal findings regarding skin reaction and life quality measures, is it justifiable to recommend more costly topical agents instead of the most cost-effective one?

Future research involving multicenter trials and larger sample size could support standard of care recommendations for the most cost-effective product (Calendula cream). The findings show no significant difference in the effectiveness of the three tested agents in terms of severity of radiation dermatitis or decrease in quality of life.