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

NCT03102866 | Completed DMC

• 2 other identifiers: OSU-16125NCI-2017-00318
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Arm lymphedema as measured by arm circumference

  Baseline up to 1 year

• Arm range of motion as measured by goniometry

  Baseline up to 1 year

• Change in weight and BMI

  Baseline up to 1 year

• Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs

  Baseline up to 1 year

• Percent increase in arm strength as measured by one repetition maximum

  Baseline up to 1 year

Study Arms (2)

Arm I (usual care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (aerobic and strength training exercise)

EXPERIMENTAL

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.

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

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (usual care)

Exercise Intervention BEHAVIORAL

Undergo aerobic and strength training exercise

Arm II (aerobic and strength training exercise)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (usual care); Arm II (aerobic and strength training exercise)

Questionnaire Administration OTHER

Ancillary studies

Arm I (usual care); Arm II (aerobic and strength training exercise)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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
• Patients with metastatic breast cancer

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Sasha Beyer, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 6, 2017
• Study Start: August 30, 2017
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)