TY - JOUR
T1 - Melatonin for prevention of breast radiation dermatitis
T2 - A phase II, prospective, double-blind randomized trial
AU - Ben-David, Merav A.
AU - Elkayam, Ruth
AU - Gelernter, Ilana
AU - Pfeffer, Raphael M.
N1 - Publisher Copyright:
© 2016, Israel Medical Association. All rights reserved.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - Background: Radiation-induced dermatitis is commonly seen during radiotherapy for breast cancer. Melatonin-based creams have shown a protective effect against ultravioletinduced erythema and a radioprotective effect in rats. Objectives: To evaluate the efficacy of melatonin-containing cream in minimizing acute radiation dermatitis. Methods: In this phase II, prospective, randomized, placebocontrolled double-blind study, patients who underwent breastconserving surgery for stage 0-2 breast cancer were randomly allocated to melatonin emulsion (26 women) or placebo (21 women) for twice daily use during radiation treatment and 2 weeks following the end of radiotherapy. All women received 50 Gy whole breast radiation therapy with 2 Gy/fx using computed tomography-based 3D planning. Patients were examined and completed a detailed questionnaire weekly and 2 weeks following the end of treatment. Results: The occurrence of grade 1/2 acute radiation dermatitis was significantly lower (59% vs. 90%, P = 0.038) in the melatonin group. Women older than 50 had significantly less dermatitis than younger patients (56% vs. 100%, P = 0.021). The maximal radiation dermatitis in the study group was grade 2 in 15% of the treated patients. Conclusions: Patients treated with melatonin-containing emulsion experienced significantly reduced radiation dermatitis compared to patients receiving placebo.
AB - Background: Radiation-induced dermatitis is commonly seen during radiotherapy for breast cancer. Melatonin-based creams have shown a protective effect against ultravioletinduced erythema and a radioprotective effect in rats. Objectives: To evaluate the efficacy of melatonin-containing cream in minimizing acute radiation dermatitis. Methods: In this phase II, prospective, randomized, placebocontrolled double-blind study, patients who underwent breastconserving surgery for stage 0-2 breast cancer were randomly allocated to melatonin emulsion (26 women) or placebo (21 women) for twice daily use during radiation treatment and 2 weeks following the end of radiotherapy. All women received 50 Gy whole breast radiation therapy with 2 Gy/fx using computed tomography-based 3D planning. Patients were examined and completed a detailed questionnaire weekly and 2 weeks following the end of treatment. Results: The occurrence of grade 1/2 acute radiation dermatitis was significantly lower (59% vs. 90%, P = 0.038) in the melatonin group. Women older than 50 had significantly less dermatitis than younger patients (56% vs. 100%, P = 0.021). The maximal radiation dermatitis in the study group was grade 2 in 15% of the treated patients. Conclusions: Patients treated with melatonin-containing emulsion experienced significantly reduced radiation dermatitis compared to patients receiving placebo.
KW - Breast radiation
KW - Breast-conserving therapy
KW - Melatonin
KW - Radiation dermatitis
KW - Radiation side effects
UR - http://www.scopus.com/inward/record.url?scp=84963756056&partnerID=8YFLogxK
M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???
C2 - 27228641
AN - SCOPUS:84963756056
SN - 1565-1088
VL - 18
SP - 188
EP - 192
JO - Israel Medical Association Journal
JF - Israel Medical Association Journal
IS - 3-4
ER -