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

Not Applicable

Completed

• Conditions: Stage IIB Breast Cancer; Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage II Breast Cancer; Stage IIIC Breast Cancer; Stage IIA Breast Cancer; Stage IIIB Breast Cancer
• Interventions: Other: Best Practice; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT03102866
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Study Start: 2017-08-30
• Primary Completion: 2019-04-04
• Study Completion: 2019-04-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (usual care)	Quality-of-Life Assessment	Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
Arm I (usual care)	Best Practice	Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
Arm I (usual care)	Questionnaire Administration	Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
Arm II (aerobic and strength training exercise)	Quality-of-Life Assessment	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.
Arm II (aerobic and strength training exercise)	Exercise Intervention	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.
Arm II (aerobic and strength training exercise)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot)	Up to 1 year	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.
Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II)	At 1 year	Will be compared to usual care group.

Secondary Outcome Measures

Name	Time	Method
Arm lymphedema as measured by arm circumference	Baseline up to 1 year	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
Change in weight and BMI	Baseline up to 1 year	BMI will be measured to evaluate body composition using the metric formula weight (kg)/ height 2 (m2).
Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs	Baseline up to 1 year	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.
Subjective arm health as measured by FACT-B+4	Baseline up to 1 year	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.
Arm range of motion as measured by goniometry	Baseline up to 1 year	Shoulder flexion, external and internal rotation, and abduction will be measured.
Percent increase in arm strength as measured by one repetition maximum	Baseline up to 1 year	Change in strength from baseline to post-intervention and follow-up will be obtained.
Quality of life as measured by FACT-B+4	Baseline up to 1 year	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States