CompletedPhase 2

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

Denmark48 participantsStarted 2019-04-30

Plain-language summary

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.

Who can participate

Age range

50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Use of bolus for radiation therapy (A bolus is a material which has dose absorption properties equivalent to tissue. It is placed on the irradiated area to alter dosing or target of the radiation therapy) * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiation Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin

Timeframe: Once weekly for 8 weeks

Erythema evaluated through pixel analysis of clinical photographs

Timeframe: Once weekly for 8 weeks

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23)

Timeframe: Once weekly for 8 weeks

Trial details

NCT IDNCT03716583

SponsorDennis Bregner Zetner

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-31

View on ClinicalTrials.gov More Radiation Dermatitis trials

Who can participate

Age range

50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Radiation Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin

Timeframe: Once weekly for 8 weeks

Erythema evaluated through pixel analysis of clinical photographs

Timeframe: Once weekly for 8 weeks

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23)

Timeframe: Once weekly for 8 weeks