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Completed

NCT Number: NCT03716583

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

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.

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Key information

Conditions

Radiation Dermatitis Breast Cancer Breast Diseases Breast Neoplasms Dermatitis Neoplasms Neoplasms by Site Radiation Dermatitis Acute Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

25 mg

Dimethyl Sulfoxide

Drug

150 mg

Placebos

Drug

1 g

Primary outcomes

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

    Time frame: Once weekly for 8 weeks

    This scale ranges from 0 to 4, being:

    0: No change over baseline

    • Follicular, faint or dull erythema/epilation/dry desquamation/decreased sweating
    • Tender or bright erythema, patchy moist desquamation/moderate edema
    • Confluent, moist desquamation other than skin folds, pitting edema
    • Ulceration, hemorrhage, necrosis

  2. Erythema evaluated through pixel analysis of clinical photographs

    Time frame: Once weekly for 8 weeks

    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).

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

    Time frame: Once weekly for 8 weeks

    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:

    • Not at all
    • A little
    • A lot
    • 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.

Secondary outcomes

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

    Time frame: Once weekly for 8 weeks

    The quality of life questionnaire determines patient-reported quality of life through a series of questions. 28 of 30 questions in the C30-module (Core questionnaire) are answered on a scale of 1-4, meaning:

    • Not at all
    • A little
    • A lot
    • Very much The questions vary between symptoms, feelings and activities of daily living.

    The remaining two questions are answered on a scale of 1 (Very bad) to 7 (Very well).

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

    Time frame: Once weekly for 8 weeks

    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:

    • Not at all
    • A little
    • A lot
    • Very much The questions vary between symptoms, feelings and activities of daily living.

    Item 1-19 are defined as a secondary outcomes outcome.

  3. Patient reported steroid cream usage

    Time frame: Once weekly for 8 weeks

    Patients will be questioned once weekly about usage of steroid cream. The questions will be:

    Have you used any steroid cream throughout your radiation therapy? (Yes/No) If yes, when did you begin using steroid cream? (Date) If yes, how many days have you used steroid cream? (Number of days)

Sponsors and collaborators

Lead sponsor

Dennis Bregner Zetner

Other

Registry information

Official study title

MELADERM-trial: Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer: a Pivotal Phase 2, Double-blind, Randomized, Placebo-controlled Trial

Acronym: MELADERM

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2018
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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