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

NCT ID: NCT03716583

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2021-01-31

Brief 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.

Detailed Description

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. The study will be performed in the Department of Oncology, Rigshospitalet, Denmark.

Eligible patients with early breast cancer receive adjuvant radiation therapy over 15 to 30 daily fractions (5 fractions per week) of ionizing megavoltage photon radiation to a total of 40 - 60 Gy within 3-5 weeks according to the guidelines of the Danish Breast Cancer Cooperative Group. In this study, the patients will administer approximately 1 g of cream containing melatonin (25 mg/g) and dimethyl sulfoxide (DMSO) (150 mg/g) or a placebo cream topically twice daily on the irradiated skin area. The patients are scheduled to do this every day from the first to the last fraction of radiation therapy, including the days where they do not receive radiation therapy. The investigators have chosen placebo as the comparator due to it being safe and the most reasonable method of evaluating any effects of the intervention. On days where the patients receive radiation, the melatonin/DMSO or placebo cream will be applied no less than 2 hours prior to radiation. Throughout the study, the patients will meet with an investigator once weekly who will monitor compliance and assess outcomes.

Conditions

Radiation Dermatitis; Radiation Dermatitis Acute; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Melatonin/DMSO

25 mg melatonin in 1 g cream twice daily for the duration of the radiation therapy

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DRUG

25 mg

Dimethyl Sulfoxide

Intervention Type: DRUG

150 mg

Placebo

1 g of cream once daily

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

1 g

Interventions

Melatonin

25 mg

Intervention Type: DRUG

Dimethyl Sulfoxide

150 mg

Intervention Type: DRUG

Placebos

1 g

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dennis Bregner Zetner

OTHER

Sponsor Role: lead

Responsible Party

Dennis Bregner Zetner

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dennis B Zetner, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Perioperativ Optimization

Locations

Rigshospitalet

Copenhagen, Capital Region, Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018-001705-91

Identifier Type: -

Identifier Source: org_study_id