A Randomized Standard-of-Care Controlled Trial of Xenogeneic Platelet-Rich Plasma Lotion to Reduce Acute Radiation Dermatitis in Breast Cancer Patients

Abstract

Breast cancer patients experience acute radiation dermatitis (ARD) during radiation therapy (RT). The Multinational Association for Supportive Cancer Care published clinical practice guidelines for the prevention and treatment of ARD in 2013, and mild bathing at the irradiated site is the standard health education. This study examined the prophylactic effect of the newly developed xenogeneic platelet-rich plasma (PRP) lotion on acute radiation dermatitis (ARD) for breast cancer patients. Ductal carcinoma in situ and early-stage breast cancers were enrolled after breast conserving surgery. Hypo-fractionated whole breast irradiation (42.5 Gy in 16 fractions) followed by tumor bed boost (10 Gy in 5 fractions) was used. Patients were randomly assigned to the Standard of Care (SOC) group (n = 48) or the PRP lotion group (n = 52). In both groups, patients were educated with standard health education on topical skin care. In the PRP lotion group, patients were instructed to apply the provided lotion twice a day, starting from the first day of RT: the first application within 1 hour after the daily RT session, the second at bedtime, and continue during the weekends. Patients were instructed not to apply the lotion within 6 hours before daily RT. We recorded the following skin reaction every week during RT and two weeks after RT: ARD was graded following the RTOG definition by two radiation oncologists; Dermatology Life Quality Index (DLQI) and Visual Analogue Scale for Pain (VAS Pain) were subjectively scored by patients to present patient-reported outcomes. The statistical software was used for all statistical analyses. The patient characteristics in both groups were balanced except for a higher body mass index in the PRP lotion group. One patient did not complete RT in the SOC group due to pain intolerance. The severity of ARD grading in both groups is shown in Table. In comparison to the SOC group, the PRP lotion group demonstrated significantly reduced and delayed progression of ARD (p<0.01) and VAS Pain (p<0.01) during the whole RT course and two weeks after RT. The DLQI significantly improved at the 2nd week (p = 0.003), 3rd week (p = 0.01), 4th week (p<0.001), and the two weeks post-RT (p<0.001) period; however, this was not observed during the 1st week (p = 0.68). Similarly, the DLQI value progressively worsened two weeks after RT in the SOC group but not in the PRP lotion group. This is the first study to use xenogeneic PRP lotion to prevent ARD clinically. The outcome of this study validated the prophylactic effects of xenogeneic PRP lotion on ARD, subsequently leading to an improved quality of life across the RT course.