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

Ohio State University Comprehensive Cancer Center4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: At 1 year

Secondary Outcomes

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