Can Aerobic and Strength Training Exercise Initiated During and Continued After Radiation Therapy for Breast Cancer Improve Fitness and Arm Health 1 Year Later?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot)
研究概览
简要总结
This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. (Pilot) II. To determine the percent increase in fitness as measured by the 6 minute walk test in women receiving radiation therapy for breast cancer randomized to an exercise program at 1 year. (Phase II)
SECONDARY OBJECTIVES:
I. Percent adherence to exercise at 1 year as measured by the International Physical Activity Questionnaire and exercise logs.
II. Subjective arm health at 1 year as measured by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4).
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage II-III breast cancer
- •Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection
- •Prior chemotherapy in the neoadjuvant or adjuvant setting
- •Radiation plan consisting of regional nodal radiation
- •Must be suitable for an exercise program
排除标准
- •Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician
- •Physical handicap that would prevent participation in program
- •Patients with metastatic breast cancer
结局指标
主要结局
Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot)
时间窗: Up to 1 year
determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program.
Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II)
时间窗: At 1 year
Will be compared to usual care group.
次要结局
- Arm lymphedema as measured by arm circumference(Baseline up to 1 year)
- Change in weight and BMI(Baseline up to 1 year)
- Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs(Baseline up to 1 year)
- Subjective arm health as measured by FACT-B+4(Baseline up to 1 year)
- Arm range of motion as measured by goniometry(Baseline up to 1 year)
- Percent increase in arm strength as measured by one repetition maximum(Baseline up to 1 year)
- Quality of life as measured by FACT-B+4(Baseline up to 1 year)
研究者
Sasha Beyer
Principal Investigator
Ohio State University Comprehensive Cancer Center