A prospective randomized, placebo-controlled skin care study in women diagnosed with breast cancer undergoing radiation therapy.

PURPOSE/
OBJECTIVES: To compare the effectiveness of three different skin care products versus a placebo in reducing the incidence of radiation therapy-induced skin reactions prophylactically.
DESIGN: Prospective randomized, double-blinded, placebo-controlled study.
SETTING: A radiation oncology department at a National Cancer Institute-designated comprehensive cancer center in the southeastern United States. SAMPLE: 208 women with breast cancer who were to receive whole breast radiation therapy.
METHODS: Patients were invited to participate after radiation therapy was documented as part of their treatment plan. Patients applied a skin care product starting on the first day of treatment and were assessed weekly by their radiation oncology nurse. MAIN RESEARCH VARIABLES: Skin reaction score and skin product.
FINDINGS: None of the products were statistically better than placebo in preventing skin reactions. Increases in skin reaction over time did not vary with treatment group for the linear (p = 0.16) and nonlinear (p = 0.94) effects of time and for both time components tested together (p = 0.41).
CONCLUSIONS: Ninety-five percent of women participating in this study experienced a radiation therapy-induced skin reaction. IMPLICATIONS FOR NURSING: The development of guidelines to support safe patient care is encouraged because patients prefer to take action rather than do nothing. However, the findings do not demonstrate improved clinical outcomes with the use of skin care products. Healthcare providers should proactively educate patients about acute skin reactions and self-care strategies to minimize skin breakdown.

RCT Entities:   Population Interventions Outcomes