Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer

What Was Tested

In this phase 2 trial, researchers set out to test DMSO (dimethyl sulfoxide, non-peptide solvent).

The aim of the present randomized double-blinded placebo-controlled clinical trial is to investigate if melatonin can protect against acute radiation dermatitis in patients with early breast cancer receiving radiation therapy, and whether this has an impact on the patients' quality of life.

It had two arms (groups): Melatonin/DMSO (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The study will be a randomized, placebo-controlled, double-blinded clinical pivotal trial.

Patients will be allocated in a ratio of 1:1 to the melatonin or placebo group.

Patients will be stratified according to the type of surgery (lumpectomy or mastectomy).

Randomization will be performed in blocks of randomized sizes.

Who Took Part

48 actual participants took part.

It was open to women only aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosed with early breast cancer. Over 49 years old. Have had radical tumor resection surgery. Follows treatment regimens and follow-up at Rigshospitalet. Written informed consent after written and verbal information.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: inability to understand danish, written or spoken; mental illness (defined as having a diagnosis and being in medical treatment, or if anticipated poor compliance); previous therapy with ionizing radiation in the thoracic or neck area.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got DMSO (dimethyl sulfoxide, non-peptide solvent) and who got the comparison, which limits bias.

The DMSO (dimethyl sulfoxide, non-peptide solvent) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on DMSO (dimethyl sulfoxide, non-peptide solvent), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-04-30 with completion listed for 2021-01-31.

It ran at 1 site in Denmark.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Radiation Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin (time frame: Once weekly for 8 weeks). Erythema evaluated through pixel analysis of clinical photographs (time frame: Once weekly for 8 weeks). European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23) (time frame: Once weekly for 8 weeks).

It also tracked 3 secondary outcomes, for example European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core module (QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23) and Patient reported steroid cream usage.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent) in 48 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the DMSO (dimethyl sulfoxide, non-peptide solvent) compound page, all human trials.