Quality‐of‐life outcomes following topical melatonin application against acute radiation dermatitis in patients with early breast cancer: A double‐blind, randomized, placebo‐controlled trial

Abstract

The aim of this double-blind, placebo-controlled, randomized study was to investigate whether topical melatonin administered during radiation therapy could increase the quality of life in patients with primary breast cancer.Patients were followed from the first radiation fraction until 3 weeks after the last. The patients applied 1 g of cream to the irradiated area of the skin twice daily, consisting of either 25 mg/g melatonin and 150 mg/g dimethyl sulfoxide, or a placebo cream. Outcomes were the European Organisation for Research and Treatment of Cancer's quality-of-life questionnaires for breast cancer (QLQ-C30 and QLQ-BR23) on the last day of radiation therapy. As a secondary outcome, we evaluated the breast symptom (BS) scores over the entire duration of the trial in a repeated measures linear model. We included 65 patients and had 17 drop-outs, thus totaling 26 and 22 patients in the melatonin and placebo groups, respectively. BS scores on the last day of radiation did not differ between groups (p = .333). However, the linear model analyzing BS for the entire duration showed that melatonin significantly decreased the symptoms (p = .001). There was no difference in the BS score on the last day of radiation, however, we found that the patients in the melatonin group had significantly lower BS scores over the entire duration of the trial.

Therapeutic Potential of Melatonin Counteracting Chemotherapy-Induced Toxicity in Breast Cancer Patients: A Systematic Review

“…In view of the functional biology of melatonin in breast cancer, the PRISMA methodology allowed the selection of RCTs that addressed this issue and evaluated the protective effects of oral melatonin in breast cancer patients treated with chemotherapy. Additionally, some promising evidence has been reported, such as the finding that topical melatonin counteracts the effects of radiotherapy in breast cancer patients [ 42 ]. To date, only eight RCTs have studied melatonin in this regard [ 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 ].…”

“…Indeed, melatonin has aroused increasing expectations in recent years as an adjuvant in breast cancer therapy, reducing side effects and enhancing the efficacy of chemotherapy [ 39 , 40 , 41 ]. However, despite promising results from preclinical studies, the use of melatonin as an adjuvant in the treatment of breast cancer is still in the early stages of study, with some results suggesting potential benefits [ 42 ] and others not finding any effects [ 43 ]. Factors that may contribute to the variability in preliminary clinical results include differences in patient cohorts, dosing regimens, or study design.…”

Clinical Studies Using Topical Melatonin

“…Recently, Zetner et al reported the results of a randomized, double-blind, placebocontrolled trial in which melatonin was employed to reduce the side effects caused by radiotherapy in subjects receiving a total of either 40.5 Gy or 50 Gy of radiation [63]. There were 65 women who were enrolled in this study but 17 dropped out, thus leading to 26 and 22 patients in the melatonin and placebo groups, respectively.…”

Multifunctional Nanoplatform-Mediated Chemo-Photothermal Therapy Combines Immunogenic Cell Death with Checkpoint Blockade to Combat Triple-Negative Breast Cancer and Distant Metastasis

“…[2][3][4] Current mainstream treatments include surgery removal, radiotherapy, chemotherapy, and endocrine therapy. [5][6][7][8][9][10] However, the inhibitory effects of monotherapy on TNBC are limited. 11 Among emerging therapeutic modalities, photothermal therapy (PTT), as a minimally invasive therapeutic strategy, has been extensively explored to treat breast cancer, which presented fairly high effectiveness.…”