Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer
NCT ID: NCT03102866
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2017-08-30
2019-04-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (usual care)
Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
Best Practice
Receive usual care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (aerobic and strength training exercise)
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.
Exercise Intervention
Undergo aerobic and strength training exercise
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive usual care
Exercise Intervention
Undergo aerobic and strength training exercise
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Physical handicap that would prevent participation in program
* Patients with metastatic breast cancer
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Sasha Beyer
Principal Investigator
Principal Investigators
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Sasha Beyer, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2017-00318
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-16125
Identifier Type: -
Identifier Source: org_study_id