title: Melatonin for Prevention of Breast Radiation Dermatitis: A Phase II, Prospective, Double-Blind Randomized Trial.
abstract: BACKGROUND
  Radiation-induced dermatitis is commonly seen during radiotherapy for breast cancer. Melatonin-based creams have shown a protective effect against ultraviolet-induced erythema and a radioprotective effect in rats.
  
  
  OBJECTIVE
  To evaluate the efficacy of melatonin-containing cream in minimizing acute radiation dermatitis.
  
  
  METHODS
  In this phase II, prospective, randomized, placebo-controlled double-blind study, patients who underwent breast-conserving 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.
authors.forename: Merav A
authors.initials: MA
authors.lastname: Ben-David
authors.forename: Ruth
authors.initials: R
authors.lastname: Elkayam
authors.forename: Ilana
authors.initials: I
authors.lastname: Gelernter
authors.forename: Raphael M
authors.initials: RM
authors.lastname: Pfeffer
mesh_terms: D000975:Antioxidants / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000532:radiotherapy / Q000601:surgery; D004311:Double-Blind Method; D004655:Emulsions; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental / Q000379:methods*; D008550:Melatonin / Q000008:administration & dosage*; D008875:Middle Aged; D059351:Organ Sparing Treatments / Q000379:methods; D011855:Radiodermatitis / Q000209:etiology / Q000517:prevention & control; D011878:Radiotherapy / Q000009:adverse effects* / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; D004655:Emulsions; D008550:Melatonin