MELADERM-trial: Melatonin cream against acute radiation dermatitis in patients with early breast cancer

Zetner, Dennis; Kamby, Claus; Mahmood, Faisal; Rosenberg, Jacob

doi:10.32794/mr11250010

Cited by 5 publications

(17 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As a result, treating irradiated skin with mometasone ointment twice daily from the first day of RT to 14 days after completion is often recommended to reduce the severity of acute dermatitis ( Ho et al, 2018 ). Recent studies have also demonstrated that barrier creams and films, as well as melatonin-based creams, may decrease the incidence of radiation dermatitis and moist desquamation and delay the development of radiation dermatitis-associated pruritus ( Ben-David et al, 2016 , Laffin et al, 2015 , Shaw et al, 2015 , Zetner et al, 2019 ). In addition, glutamine supplementation, olive oil/calcium hydroxide emulsions, and many other agents have been shown to reduce the incidence and severity of radiation dermatitis in small studies ( Chitapanarux et al, 2019 , Eda et al, 2016 ).…”

Section: Radiation Dermatitismentioning

confidence: 99%

Dermatologic toxicities associated with radiation therapy in women with breast cancer

Ramseier

Ferreira

Leventhal

2020

International Journal of Women's Dermatology

View full text Add to dashboard Cite

Breast-conserving surgery with adjuvant radiation therapy has become the standard of care for women with early stage breast cancer, and as a result, a large number of patients are affected by the cutaneous sequelae of radiation therapy. These dermatologic toxicities may present during treatment or years later and can significantly impact patients’ quality of life. In this review, we discuss the clinical presentation, prevention, and management of radiation-induced cutaneous toxicities in women with breast cancer, including radiation dermatitis, radiation recall, radiation-induced morphea, radiation-induced fibrosis, and cutaneous malignancies in irradiated skin.

show abstract

Section: Radiation Dermatitismentioning

confidence: 99%

Dermatologic toxicities associated with radiation therapy in women with breast cancer

Ramseier

Ferreira

Leventhal

2020

International Journal of Women's Dermatology

View full text Add to dashboard Cite

show abstract

“…Correspondingly, safety evaluations are needed for the different administration routes, evaluating both local and systemic harms. Currently, an increasing clinical interest relates to the radioprotective [16,[35][36][37][38], antioxidant [39,40], and anticancer [41][42][43][44] properties of melatonin. Localized radiation therapy may be combined with local melatonin administration regimens, for example, administered transdermally, rectally, vaginally, or intravesically, thus increasing local tissue concentration gradients and potentially limiting drug-related systemic adverse effects.…”

Section: Discussion/conclusionmentioning

confidence: 99%

“…Melatonin was administered intravenously, intravesically, rectally, transdermally, and vaginally to all participants with a wash-out period of at least 7 days between each study session. A dose of 25 mg of melatonin was chosen since this was the dose to be used in another clinical trial [16]. This dose is in coherence with other studies investigating the protective effects of melatonin in cancer therapy [13][14][15]17].…”

Section: Methodsmentioning

confidence: 99%

“…With these indications, between 2 and 10 mg of melatonin is administered [12]. Currently, alternative indications are also being evaluated, such as the radioprotective effects in patients receiving radiotherapy as part of oncological treatments [13][14][15][16]. Interestingly, in oncological trials, increased doses up to 40 mg are administered [17].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetics and Safety of Intravenous, Intravesical, Rectal, Transdermal, and Vaginal Melatonin in Healthy Female Volunteers: A Cross-Over Study

et al. 2020

Self Cite

View full text Add to dashboard Cite

Introduction: We aimed to investigate the pharmacokinetic properties and safety of melatonin administered by alternative routes of administration. Methods: This study employed a cross-over design in healthy female volunteers. Twenty-five milligrams of melatonin was administered intravenously, intravesically, rectally, transdermally, and vaginally. Blood samples were collected at specified time points up to 24 h following intravenous, intravesical, rectal, and vaginal administration, and up to 48 h following transdermal administration. Plasma melatonin concentrations were determined by radioimmunoassay. Sedation was evaluated by a simple reactiontime test, and sleepiness was assessed by the Karolinska Sleepiness Scale. Adverse events were registered for each route of administration. Results: Ten participants were included. We documented a mean (SD) time to maximal concentration of 51 (29) min for intravesical, 24 (20) min for rectal, 21 (8) h for transdermal, and 147 (56) min for vaginal administration. The mean (SD) elimination half-life was 47 (6) min for intravenous, 58 (7) min for intravesical, 60 (18) min for rectal, 14.6 (11.1) h for transdermal, and 129 (17) min for vaginal administration. The mean (SD) bioavailability was 3.6 (1.9)% for intravesical, 36.0 (28.6)% for rectal, 10.0 (5.7)% for transdermal, and 97.8 (31.7)% for vaginal administration. No significant changes in reaction times were observed following administration of melatonin by any of the administration routes. Increased tiredness was documented following transdermal administration only. No serious adverse effects were documented. Conclusion: Rectally and vaginally administered melatonin may serve as relevant alternatives to standard oral melatonin therapy. Transdermal delivery of melatonin displayed an extended absorption and can be applied if prolonged effects are intended. Intravesical administration displayed, as expected, a very limited bioavailability. Melatonin administered by these routes of administration was safe.

show abstract

“…This was a randomized, double‐blind, controlled, clinical trial in women receiving radiation therapy due to primary breast cancer. We have previously published the study protocol 10 . The study was registered at https://Clinicaltrials.gov (NCT03716583), and the study was reported according to the CONSORT statement 11 .…”

Section: Methodsmentioning

confidence: 99%

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

Zetner

Kamby

Gülen

et al. 2022

Journal of Pineal Research

Self Cite

View full text Add to dashboard Cite

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.

show abstract

MELADERM-trial: Melatonin cream against acute radiation dermatitis in patients with early breast cancer

Cited by 5 publications

References 29 publications

Dermatologic toxicities associated with radiation therapy in women with breast cancer

Dermatologic toxicities associated with radiation therapy in women with breast cancer

Pharmacokinetics and Safety of Intravenous, Intravesical, Rectal, Transdermal, and Vaginal Melatonin in Healthy Female Volunteers: A Cross-Over Study

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

Contact Info

Product

Resources

About