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

The Ohio State University

Status: Completed

Conditions: Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIB Breast Cancer; Stage IIA Breast Cancer; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer

Treatments: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03102866

OSU-16125

NCI-2017-00318 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Arm I (usual care)

Active Comparator group

Description:

Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.

Treatment:

Other: Quality-of-Life Assessment

Other: Best Practice

Other: Questionnaire Administration

Arm II (aerobic and strength training exercise)

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Intervention

Other: Quality-of-Life Assessment

Other: Questionnaire Administration