Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 184
- 主要终点
- Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.
研究概览
简要总结
RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis.
PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of mometasone furoate vs placebo, in terms of decreased maximal severity of radiation dermatitis, in patients undergoing primary or adjuvant radiotherapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.
Secondary
- Compare the incidence of severe (grade ≥ 3) radiation dermatitis in patients treated with these drugs.
- Compare the time to onset and duration of severe radiation dermatitis in these patients.
- Assess skin toxicity and quality of life of these patients.
- Assess the adverse event profile of mometasone furoate in these patients.
- Compare skin toxicity data, in terms of provider-completed and patient-reported assessments, of patients treated with these drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mometasone
Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
干预措施: mometasone furoate (Drug)
Placebo
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.
干预措施: placebo (Other)
结局指标
主要结局
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.
时间窗: During Radiation Treatment, up to a maximum of 9 weeks.
Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).
次要结局
- Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)(During Radiation Treatment, up to a maximum of 11 weeks.)
- QOL Domains as Measured by LASA(During Radiation Treatment, up to a maximum of 11 weeks.)
- Adverse Events Assessed Clinically by NCI CTCAE v3.0(During Radiation Treatment, up to a maximum of 9 weeks.)
- Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).(During Radiation Treatment, up to a maximum of 11 weeks.)
- Incidence of Severe ( Grade >=3) Radiation Dermatitis(During Radiation Treatment, up to a maximum of 9 weeks.)
- Skin Toxicity as Measured by the Skin Toxicity Assessment Tool(During Radiation Treatment, up to a maximum of 9 weeks.)
- Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).(During Radiation Treatment, up to a maximum of 11 weeks.)
- Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.(During Radiation Treatment, up to a maximum of 9 weeks.)