Clareo Health | Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer
Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer
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Lead
Ohio State University Comprehensive Cancer Center
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.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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