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

Can Aerobic and Strength Training Exercise Initiated During and Continued After Radiation Therapy for Breast Cancer Improve Fitness and Arm Health 1 Year Later?

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (usual care); Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy
Experimental: 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Behavioral: Exercise Intervention; Undergo aerobic and strength training exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Sasha Beyer, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): April 4, 2019
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OSU-16125; NCI-2017-00318 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No