Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Proportion of participants with a greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery
研究概览
简要总结
This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.
A Perometer and Sozo devise will be used to measure volume changes
详细描述
This study will compare patients' relative arm volume changes and symptoms data from before drug therapy throughout drug treatment and for up to six months after treatment has finished.
A Perometer and Sozo device will be used to measure volume changes
All participants will be accrued at Massachusetts General Hospital for a target accrual of 166 participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF/HCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.
- •Subjects that will be eligible for the study include:
- •Females between 18 and 80 years of age
- •With a history of breast cancer
- •4 weeks or more post-surgery
- •With or without edema
- •Undergoing treatment with targeted therapy for early or metastatic disease.
排除标准
- •- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).
研究组 & 干预措施
Target Therapy Drug-Stand Care
Screening procedures confirm participation in the research study.
- Participants limb volume is measured prior to treatment start date.
- Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card.
- Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication
干预措施: Perometer (Device)
Target Therapy Drug-Stand Care
Screening procedures confirm participation in the research study.
- Participants limb volume is measured prior to treatment start date.
- Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card.
- Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication
干预措施: SOZO device (Device)
Target Therapy-Early or Metastatic Breast Cancer
Screening procedures confirm participation in the research study.
- Participants limb volume is measured prior to treatment start date.
- Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card.
- Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication
干预措施: Perometer (Device)
Target Therapy-Early or Metastatic Breast Cancer
Screening procedures confirm participation in the research study.
- Participants limb volume is measured prior to treatment start date.
- Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card.
- Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication
干预措施: SOZO device (Device)
结局指标
主要结局
Proportion of participants with a greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery
时间窗: At least three months post surgery up to 5 years, assessed every 3 months
Greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery
次要结局
- To assess the time course to lymphedema onset(5 Years)
- To asses the correlation of different targeted therapies with lymphedema onset(5 Years)
研究者
Alphonse Taghian
Principal Investigator
Massachusetts General Hospital