Muscle Loss and Fatigue as a Consequence of Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 主要终点
- Changes in self-reported fatigue using the validated questionnaire "Brief Fatigue Inventory"
研究概览
简要总结
This study examines the extent of systemic muscle loss and the degree of fatigue experienced by breast cancer patients undergoing radiotherapy. This study seeks to identify whether muscle loss occurs outside the radiation fields and if muscle loss is correlated with the degree of fatigue.
详细描述
This study uses a patient reported survey to assess fatigue prior to radiotherapy for breast cancer. Fatigue is measured again at the completion of radiation treatments and at one and three months following completion of radiation.
Muscle measurements are made outside the treatment area using ct scans prior to radiation treatment, at the completion of radiation treatment and at one and three months after radiation treatment. The degree of fatigue and changes in muscle will be assessed. Changes will be correlated to determine if muscle loss contributes to fatigue.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women Age ≥ 18 years
- •Non-metastatic breast cancer for which post-operative radiation treatment has been recommended as standard of care
- •Able to provide informed consent
- •Able to complete the Brief Fatigue Inventory questionnaire -
排除标准
- •Inability to meet eligibility requirements -
结局指标
主要结局
Changes in self-reported fatigue using the validated questionnaire "Brief Fatigue Inventory"
时间窗: 5 months
Subjects will complete the Brief Fatigue Inventory questionnaire on the first day of radiation treatment, the last day of radiation treatment and one month and three months after the last radiation treatment. All dates are +/- one week. The length of radiation treatment will be determined by the treating physician as standard of care, typically four to six weeks depending on disease characteristics.
Changes in muscle area outside the radiation treatment area determined on cross sectional anatomy from CT scan images
时间窗: 5 months
Subjects will undergo ct scan imaging on the first day of radiation treatment, the last day of radiation treatment and one month and three months after the last radiation treatment. All dates are +/- one week. The length of radiation treatment will be determined by the treating physician as standard of care, typically four to six weeks depending on disease and patient characteristics. Muscle area will be determined on specified anatomic levels using automated image analysis of CT images.
Correlation between muscle area and fatigue
时间窗: 5 months
Changes in cross-sectional muscle area during and after radiotherapy will be compared with changes in self reported fatigue to determine if correlations exist between changes in fatigue and cross sectional muscle area.
次要结局
- Changes in cross-sectional muscle area within the radiation treatment area measured on ct scans(5 months)