Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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). III. Arm lymphedema at 1 year as measured by arm circumference. IV. Arm range of motion at 1 year as measured by goniometry. V. Quality of life at 1 year as measured by FACT-B+4. VI. Percent increase in arm strength as measured by one repetition maximum at 1 year. VII. Change in weight and body mass index (BMI) 1 year after completion of radiation. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. ARM II: Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. After completion of study, patients are followed up at 1 year.

Official Title
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Can Aerobic and Strength Training Exercise Initiated During and Continued After Radiation Therapy for Breast Cancer Improve Fitness and Arm Health 1 Year Later?

Conditions
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Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Intervention / Treatment
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* Other: Best Practice
* Behavioral: Exercise Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (usual care)<br>Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (aerobic and strength training exercise)<br>Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. | Behavioral: Exercise Intervention<br>* Undergo aerobic and strength training exercise<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot) | 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. | Up to 1 year | 
| Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II) | Will be compared to usual care group. | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm lymphedema as measured by arm circumference | Lymphedema will be classified into 3 stages. Stage I edema is reversible and characterized by pitting edema, increase in arm girth, and heaviness. Stage II is characterized by a spongy consistency of the arm without pitting edema. Stage III is the most advanced stage, lymphostatic elephantiasis | Baseline up to 1 year | 
| Arm range of motion as measured by goniometry | Shoulder flexion, external and internal rotation, and abduction will be measured. | Baseline up to 1 year | 
| Change in weight and BMI | BMI will be measured to evaluate body composition using the metric formula weight (kg)/ height 2 (m2). | Baseline up to 1 year | 
| Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs | Duration of exercise will be calculated based on questionnaire and exercise log. Percentage of exercise adherence at 1-year follow-up will be compared between two groups. Generalized linear models will be utilized to model follow-up as a function of baseline and group. | Baseline up to 1 year | 
| Percent increase in arm strength as measured by one repetition maximum | Change in strength from baseline to post-intervention and follow-up will be obtained. | Baseline up to 1 year | 
| Quality of life as measured by FACT-B+4 | The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales (0 - 4) for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms. | Baseline up to 1 year | 
| Subjective arm health as measured by FACT-B+4 | The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales (0 - 4) for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms. | Baseline up to 1 year |