A Randomized Controlled Trial on the Use of Heparinoid Moisturizer for Improving Quality of Life with Acute Radiation Skin Damage from Radiation Therapy after Breast-Conserving Surgery

Abstract

Heparinoid (HP) moisturizer application following radiation therapy increases water content in the stratum corneum and improves skin desquamation and dryness for radiation dermatitis caused by radiation therapy after breast-conserving surgery (BCT-RT). Improvement of dry skin by moisturizer application may also help to improve patient quality of life (QOL) in this setting. The aim of this study was to evaluate the effect of HP moisturizer use on quality of life in patients with acute radiation skin damage after BCT-RT. We performed a randomized controlled trial of a moisturizer group (Group P) and a no-moisturizer group (Group C) to examine whether HP application as moisturizer contributed to improvements in QOL among patients with radiation skin reaction due to BCT-RT. A total of 75 patients who received BCT-RT between October 2017 and September 2018 were randomly allocated in our hospital to Group P and Group C. Group P applied HP from the radiation start date, HP twice daily for 7 weeks. QOL was assessed using the Dermatology Life Quality Index (DLQI) at the radiation start date, and at Weeks 1, 2, 3, 4, 5 and 7 after the radiation start date. A higher DLQI score indicates a worse quality of life. The primary endpoint was mean total DLQI score at 4 weeks after the start date, with secondary endpoints of total DLQI score, DLQI subscores (Symptoms and feelings; Daily activities; Leisure; Work and school; Personal relationship; and Treatment score) at each time point. Radiation treatment was whole-breast irradiation (42.56 Gy in 16 fractions); with added tumor bed boost (10-15 Gy in 4-6 fractions) in 17 cases, according to our hospital protocol. Three cases dropped out, and 72 cases were analyzed (Group P, 35 cases; Group C, 37 cases). The mean (± standard deviation) DLQI total scores 4 weeks after the start date was 2.063±2.169 in Group P, and 2.233±2.161 in Group C. No significant difference between P and C groups was seen (Mann-Whitney U test, p=0.894). In both groups, the DLQI total score showed no significant change until 2 weeks after the start date, and significantly worsened from 3 weeks to 5 weeks after the start date. No significant difference was seen between groups at 7 weeks after the start date. In subscores, “Symptoms and feelings” showed changes similar to the total DLQI score, and no significant differences were seen between 7 weeks after the start date and start date only in the P group. DLQI scores were lower at all observation periods for “Daily activities,” “Leisure”, “Personal relationship,” and “Treatment.” In terms of DLQI total score, no significant improvement was obtained from moisturizer application 4 weeks after the start of radiation. Seven weeks after the start date, “Symptoms and feelings” were restored by moisturizer application to the baseline score at initiation. With hypofractionated irradiation, changes in QOL were minimal.