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

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dennis Bregner Zetner
• Treatments: Dimethyl Sulfoxide; Melatonin

Criteria

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