Clinical trial 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
Official 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 4
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot)
timeFrame: Up to 1 year
measure: Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II)
timeFrame: At 1 year
Secondary outcomes:
measure: Arm lymphedema as measured by arm circumference
timeFrame: Baseline up to 1 year
measure: Arm range of motion as measured by goniometry
timeFrame: Baseline up to 1 year
measure: Change in weight and BMI
timeFrame: Baseline up to 1 year
measure: Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs
timeFrame: Baseline up to 1 year
measure: Percent increase in arm strength as measured by one repetition maximum
timeFrame: Baseline up to 1 year
measure: Quality of life as measured by FACT-B+4
timeFrame: Baseline up to 1 year
measure: Subjective arm health as measured by FACT-B+4
timeFrame: Baseline up to 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Sasha Beyer, MD
role: PRINCIPAL_INVESTIGATOR
References: