Feasibility and Effects of Manual Lymphatic Drainage (MLD) Breast Massage in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of compliance of MLD breast massage sessions
研究概览
简要总结
This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate the feasibility of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.
SECONDARY OBJECTIVES:
I. Evaluate the tolerability of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.
II. Preliminarily assess the effect on acute and chronic breast edema, pain, functional status, quality of life, body image and radiation induced fibrosis (RIF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with native breasts and localized breast cancer who are status post-lumpectomy surgery, will receive whole breast radiation therapy with/without nodal irradiation, with standard fractionation or moderate hypofractionation
- •Age >= 18 years
- •Ability to understand and the willingness to sign a written informed consent in English or Spanish
排除标准
- •Underlying diagnosis of chronic inflammatory illness or collagen vascular disorder, e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions may significantly affect the likelihood and magnitude of radiation related toxicity
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Inability to provide written informed consent in English or Spanish
- •Patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded
研究组 & 干预措施
Supportive care (MLD breast massage)
Patients undergo MLD breast massage over 30-60 minutes BIW for the duration of SOC radiation therapy and for 1 month thereafter.
干预措施: Lymphedema Management (Other)
Supportive care (MLD breast massage)
Patients undergo MLD breast massage over 30-60 minutes BIW for the duration of SOC radiation therapy and for 1 month thereafter.
干预措施: Adjuvant breast radiation therapy (Radiation)
Supportive care (MLD breast massage)
Patients undergo MLD breast massage over 30-60 minutes BIW for the duration of SOC radiation therapy and for 1 month thereafter.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Rate of compliance of MLD breast massage sessions
时间窗: Up to 1 month after completion of radiation
The intervention compliance rate will be calculated as the percentage of completed treatment sessions over the total targeted treatment sessions.
次要结局
- Assess the effect of MLD breast massage breast edema(Up to 1 year)
- Assess the effect of MLD breast massage on pain(Up to 1 year)
- Assess the effect of MLD breast massage on functional status(From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months))
- Assess the effect of MLD breast massage on quality of life(From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months))
- Assess the effect of MLD breast massage on body image(From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months))