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NCT Number: NCT03102866

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

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.

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Key information

Conditions

Stage II Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stage IIA Breast Cancer Stage IIB Breast Cancer Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Exercise Intervention

Behavioral

Undergo aerobic and strength training exercise

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot)

    Time frame: 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.

  2. Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II)

    Time frame: At 1 year

    Will be compared to usual care group.

Secondary outcomes

  1. Arm lymphedema as measured by arm circumference

    Time frame: 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

  2. Arm range of motion as measured by goniometry

    Time frame: Baseline up to 1 year

    Shoulder flexion, external and internal rotation, and abduction will be measured.

  3. Change in weight and BMI

    Time frame: Baseline up to 1 year

    BMI will be measured to evaluate body composition using the metric formula weight (kg)/ height 2 (m2).

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

    Time frame: 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.

  5. Percent increase in arm strength as measured by one repetition maximum

    Time frame: Baseline up to 1 year

    Change in strength from baseline to post-intervention and follow-up will be obtained.

  6. Quality of life as measured by FACT-B+4

    Time frame: 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.

  7. Subjective arm health as measured by FACT-B+4

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2017
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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