Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer
NCT03716583 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2021-09-10
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.
Conditions
- Radiation Dermatitis
- Radiation Dermatitis Acute
- Breast Cancer
Interventions
- DRUG
-
Melatonin
25 mg
- DRUG
-
Dimethyl Sulfoxide
150 mg
- DRUG
-
Placebos
1 g
Sponsors & Collaborators
-
Dennis Bregner Zetner
lead OTHER
Principal Investigators
-
Dennis B Zetner, MD · Center for Perioperativ Optimization
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-30
- Primary Completion
- 2021-01-31
- Completion
- 2021-01-31
Countries
- Denmark
Study Locations
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