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.

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.

Effect of melatonin cream on acute radiation dermatitis in patients with primary breast cancer: A double-blind, randomized, placebo-controlled trial.

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.

Most Cochrane reviews have not been updated for more than 5 years.

AIM: Cochrane reviews are internationally recognized for their high quality, but to reduce the risk of transmitting misleading information, they must be kept up to date. The aim of this study was to quantify the number of reviews in the Cochrane Database of Systematic Reviews (CDSR) that have not been updated for more than five years and to characterize them. METHOD: This study was reported closely adapted to the STROBE guidelines. Information about all reviews in the CDSR was extracted in August 2020. Based on a previous study, we defined inactive reviews as reviews with no update in "What's New" or no publication of a new version of the review within the last 5.5 years. The inactive reviews were quantified and characterized and results were visualized through tables and charts. RESULTS: The study included 7931 reviews from the CDSR. The median age of all reviews in the CDSR was 5.3 years. Fifty-five percent were published for the first time between 1996 and February 2015 and 88% of these had been inactive for 5.5 years or more. Among these, 89% were first publication of the review that had never been updated afterward. CONCLUSION: More than half of the Cochrane reviews in CDSR were first published before 2015 and only 12% of these were still active. In order to retain their validity, it would be preferable if Cochrane reviews were kept up to date by the authors either by an update in "What's New" or by publishing a new version of the review.