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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00318 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (usual care) | Active Comparator | Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. |
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| Arm II (aerobic and strength training exercise) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sasha Beyer, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Exercise Intervention | Behavioral | Undergo aerobic and strength training exercise |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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