TY - JOUR

T1 - Effect of melatonin cream on acute radiation dermatitis in patients with primary breast cancer

T2 - A double-blind, randomized, placebo-controlled trial

AU - Zetner, Dennis

AU - Kamby, Claus

AU - Christophersen, Camilla

AU - Gülen, Sengül

AU - Paulsen, Cecilie B.

AU - Piga, Emily

AU - Hoffmeyer, Bodil

AU - Mahmood, Faisal

AU - Rosenberg, Jacob

N1 - Funding Information: The study was registered at clinicaltrials.gov (NCT03716583), and the protocol was published previously. The study was funded by RepoCeuticals A/S. Both the melatonin and placebo treatments used in the trial have been donated by RepoCeuticals A/S, who had no influence on the design, interpretation, or publication of data. 13 Publisher Copyright: © 2023 The Authors. Journal of Pineal Research published by John Wiley & Sons Ltd.

PY - 2023

Y1 - 2023

N2 - Aim: This was a double-blind, placebo-controlled randomized study investigating whether melatonin can protect against radiation dermatitis in women receiving radiation therapy for primary breast cancer. Methods: Patients were included before radiation therapy and followed once weekly throughout treatment with a 3-week follow-up. Patients applied 1 g of cream to the irradiated skin twice daily, consisting of either 25 mg/g melatonin and 150 mg/g dimethyl sulfoxide, or placebo. Our outcomes were the Radiation Therapy Oncology Group's (RTOG) acute radiation morbidity scoring criteria for skin, a pixel analysis of erythema in clinical photographs, and patients’ use of corticosteroid cream. Outcomes were evaluated once weekly throughout the trial. The primary outcomes were RTOG-score and pixel analysis at 2 weeks follow-up. Secondary outcomes were the use of corticosteroid cream and analyses of RTOG-scores and pixel analyses throughout the trial. Results: Sixty-five patients were included, 17 dropped out, totaling 26 and 22 patients randomized to melatonin and placebo, respectively. RTOG-scores and pixel analyses at 2 weeks follow-up showed no difference p =.441 and p =.890, respectively). There was no difference in the use of corticosteroid cream (p =.055). Using logistic regression, the melatonin group had a higher likelihood of having a low RTOG-score (p =.0016). The logistic regression showed no difference between the groups for the pixel analyses. Conclusion: Our primary outcome showed no difference in RTOG-scores at 2 weeks follow-up, however, the RTOG-score over the entire duration of the study demonstrated a protective effect of melatonin. Further studies are warranted investigating higher doses of melatonin, and whether corticosteroids may influence the effect of melatonin cream against radiation dermatitis.

AB - Aim: This was a double-blind, placebo-controlled randomized study investigating whether melatonin can protect against radiation dermatitis in women receiving radiation therapy for primary breast cancer. Methods: Patients were included before radiation therapy and followed once weekly throughout treatment with a 3-week follow-up. Patients applied 1 g of cream to the irradiated skin twice daily, consisting of either 25 mg/g melatonin and 150 mg/g dimethyl sulfoxide, or placebo. Our outcomes were the Radiation Therapy Oncology Group's (RTOG) acute radiation morbidity scoring criteria for skin, a pixel analysis of erythema in clinical photographs, and patients’ use of corticosteroid cream. Outcomes were evaluated once weekly throughout the trial. The primary outcomes were RTOG-score and pixel analysis at 2 weeks follow-up. Secondary outcomes were the use of corticosteroid cream and analyses of RTOG-scores and pixel analyses throughout the trial. Results: Sixty-five patients were included, 17 dropped out, totaling 26 and 22 patients randomized to melatonin and placebo, respectively. RTOG-scores and pixel analyses at 2 weeks follow-up showed no difference p =.441 and p =.890, respectively). There was no difference in the use of corticosteroid cream (p =.055). Using logistic regression, the melatonin group had a higher likelihood of having a low RTOG-score (p =.0016). The logistic regression showed no difference between the groups for the pixel analyses. Conclusion: Our primary outcome showed no difference in RTOG-scores at 2 weeks follow-up, however, the RTOG-score over the entire duration of the study demonstrated a protective effect of melatonin. Further studies are warranted investigating higher doses of melatonin, and whether corticosteroids may influence the effect of melatonin cream against radiation dermatitis.

KW - breast cancer

KW - melatonin

KW - oncology

KW - radiation dermatitis

KW - radiation therapy

KW - randomized clinical trial

KW - RTOG

U2 - 10.1111/jpi.12873

DO - 10.1111/jpi.12873

M3 - Journal article

C2 - 37055944

AN - SCOPUS:85153628315

VL - 75

JO - Journal of Pineal Research (Print)

JF - Journal of Pineal Research (Print)

SN - 0742-3098

IS - 1

M1 - e12873

ER -