MELADERM-trial: Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer: a Pivotal Phase 2, Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Radiation Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Melatonin/DMSO
25 mg melatonin in 1 g cream twice daily for the duration of the radiation therapy
干预措施: Melatonin (Drug)
Melatonin/DMSO
25 mg melatonin in 1 g cream twice daily for the duration of the radiation therapy
干预措施: Dimethyl Sulfoxide (Drug)
Placebo
1 g of cream once daily
干预措施: Placebos (Drug)
结局指标
主要结局
Radiation Therapy Oncology Group's acute radiation morbidity scoring criteria of the skin
时间窗: Once weekly for 8 weeks
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
Erythema evaluated through pixel analysis of clinical photographs
时间窗: 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).
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast symptoms (QLQ-BR23)
时间窗: 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: 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.
次要结局
- 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)
研究者
Dennis Bregner Zetner
Principal Investigator
Herlev Hospital