MELADERM-trial: Melatonin cream against acute radiation dermatitis in patients with breast cancer

Phase 1

• Conditions: Radiation dermatitis; MedDRA version: 20.0Level: LLTClassification code 10061103Term: Dermatitis radiationSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.1Level: PTClassification code 10063562Term: Radiation skin injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2018-001705-91-DK
• Lead Sponsor: Center for Perioperative Optimization, Department of Surgery, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-26
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 80

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Inability to understand Danish, written or spoken
Mental illness*
Previous therapy with ionizing radiation in the thoracic or neck area
Use of bolus for radiation therapy**

* Defined as having a diagnosis and being in medical treatment, or if anticipated poor compliance. ** 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if melatonin can protect against radiation injury in women receiving radiation therapy as part of their treatment of breast cancer.;Secondary Objective: To evaluate if melatonin can reduce the useage of steroid cream in the treatment of radiaiton dermatitis.;Primary end point(s): RTOG's acute radiation morbidity scoring criteria of the skin<br>Image analysis of clinical photographs after radiation exposure<br>EORTC's QLQ-BR23, specifically the breast symptoms;Timepoint(s) of evaluation of this end point: RTOG's acute radiation morbidity scoring criteria of the skin: Two weeks after last radiation fraction<br>Image analysis of clinical photographs after radiation exposure: Two weeks after last radiation fraction<br>EORTC's QLQ-BR23, specifically the breast symptoms: Last day of radiation therapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): RTOG's acute radiation morbidity scoring criteria of the skin<br>Image analysis of clinical photographs after radiation exposure<br>EORTC's QLQ-BR23<br>Useage of steroid cream throughout the trial;Timepoint(s) of evaluation of this end point: Once weekly during the radiation treatment, and once weekly for 3 weeks following the last radiation fraction