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

NCT03716583 | Completed Phase 2 DMC

• 1 other identifier: 2018-001705-91
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis; Radiation Dermatitis Acute; Breast Cancer

Keywords

melatonin

Outcome Measures

Primary Outcomes (3)

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

  This scale ranges from 0 to 4, being: 0: No change over baseline 1. Follicular, faint or dull erythema/epilation/dry desquamation/decreased sweating 2. Tender or bright erythema, patchy moist desquamation/moderate edema 3. Confluent, moist desquamation other than skin folds, pitting edema 4. Ulceration, hemorrhage, necrosis

  Once weekly for 8 weeks

• Erythema evaluated through pixel analysis of clinical photographs

  Erythema has previously been evaluated by a validated method using software analysis (Image J, version 1.45S, National Institute of health, USA) of digital photos \[32\]. A "color space converter" function will be used to convert the clinical photos into grayscale in the software analysis. Erythema will be quantified by pixel color analyses where all white colored pixels represent erythema. An a\*-value will represent degree of erythema (high a\*-values represent a high degree of erythema).

  Once weekly for 8 weeks

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

  The quality of life questionnaire determines patient-reported quality of life through a series of questions. All questions in the BR23-module (Breast cancer module) are answered on a scale of 1-4, meaning: 1. Not at all 2. A little 3. A lot 4. Very much The questions vary between symptoms, feelings and activities of daily living. Only item 20-23 (specifically questions about the breast area) are defined as a primary outcome. All other outcomes in the questionnaire are considered secondary outcomes.

  Once weekly for 8 weeks

Secondary Outcomes (3)

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core module (QLQ-C30)

  Once weekly for 8 weeks

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

  Once weekly for 8 weeks

• Patient reported steroid cream usage

  Once weekly for 8 weeks

Study Arms (2)

Melatonin/DMSO

EXPERIMENTAL

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

Drug: Melatonin; Drug: Dimethyl Sulfoxide

Placebo

PLACEBO COMPARATOR

1 g of cream once daily

Drug: Placebos

Interventions

Melatonin DRUG

25 mg

Melatonin/DMSO

Dimethyl Sulfoxide DRUG

150 mg

Melatonin/DMSO

Placebos DRUG

1 g

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dennis Bregner Zetner: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Interventions

Melatonin; Dimethyl Sulfoxide

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sulfoxides; Sulfur Compounds; Organic Chemicals

Study Officials

• Dennis B Zetner, MD

  Center for Perioperativ Optimization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 23, 2018
• Study Start: April 30, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

DK (1)