Exercise Intervention After Cancer Treatment for Improving Health in Stage II-III Breast Cancer Survivors

NCT ID: NCT03523195

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2019-07-15

Brief Summary

This pilot trial studies how well exercise intervention after cancer treatment works in improving physical activity in stage II-III breast cancer survivors. An exercise intervention may promote regular physical activity.

Detailed Description

PRIMARY OBJECTIVES:

I. Estimate the adherence rate of the experimental exercise program, and deem as feasible if at least 80% of participants complete 80% or more of a 12-week, 180 minute aerobic+resistance training program that combines structured, individualized onsite exercise at the Fred Hutch Prevention Center with at-home exercise.

II. Identify up to 5 circulating micro ribonucleic acid (c-miRNA) biomarkers that show the largest differential change from baseline when comparing levels in the exercise program to those in the Fitbit-activity control condition.

SECONDARY OBJECTIVES:

I. Explore associations between changes in miRNAs and serum biomarkers (IL-6, lipids, adiponectin and leptin, C-reactive protein [CRP]) and physiological outcomes (resting heart rate, blood pressure, 1 repetition max, 6 minute walk, timed up and go test) of the exercise program.

II. Explore changes in the patient-reported outcomes (PRO) in response to the exercise intervention relative to the control group, and finalize measures to use in the design of the phase III clinical trial based on descriptive changes from baseline to follow-ups in the intervention versus (vs.) control groups.

OUTLINE: Participants are randomized into 1 of 2 arms.

ARM 0: Participants wear Fitbit and receive written information on healthy exercise and diet recommendations.

ARM 1: Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week.

Conditions

Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Cancer Survivor; Estrogen Receptor Positive; HER2/Neu Negative; Progesterone Receptor Positive; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Sedentary Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Arm 0 (written information)

Participants wear Fitbit and receive written information on healthy exercise and diet recommendations.

Group Type: ACTIVE_COMPARATOR

Informational Intervention

Intervention Type: OTHER

Receive written information on healthy exercise and diet recommendations

Laboratory Biomarker Analysis

Intervention Type: OTHER

Blood tests

Monitoring Device

Intervention Type: DEVICE

Wear Fitbit

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Physical Performance Testing

Intervention Type: OTHER

Performance of physical tests

Arm I (exercise program)

Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: BEHAVIORAL

Complete exercise program

Laboratory Biomarker Analysis

Intervention Type: OTHER

Blood tests

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Physical Performance Testing

Intervention Type: OTHER

Performance of physical tests

Interventions

Exercise Intervention

Complete exercise program

Intervention Type: BEHAVIORAL

Informational Intervention

Receive written information on healthy exercise and diet recommendations

Intervention Type: OTHER

Laboratory Biomarker Analysis

Blood tests

Intervention Type: OTHER

Monitoring Device

Wear Fitbit

Intervention Type: DEVICE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Physical Performance Testing

Performance of physical tests

Intervention Type: OTHER

Other Intervention Names

Monitor; Physical Function Testing

Eligibility Criteria

Inclusion Criteria

• Single malignancy with diagnosis of breast cancer diagnosis of stage II-III, estrogen and progesterone positive, HER-2neu negative, and on stable dose of aromatase inhibitor (AI) for past 3 months, with AI expected to be stable for the study duration
• No evidence of disease
• 1-5 years post active treatment for malignancy
• Body mass index 19 to 35
• Sedentary (< 100 minutes of moderate intensity exercise per week)
• English adequate to complete assessments and follow exercise instructions
• Able to independently use transportation to attend 2-day a week onsite exercise training
• Access to a computer or smartphone

Exclusion Criteria

• Current tobacco use or electronic cigarette smoker
• Pregnant
• Diabetes requiring insulin injection
• Lymphedema that restricts range of motion or with worsening symptoms in the past month, or without compression garment
• Weight change of more than 10 pounds in previous 3 months will exclude from study participation at baseline
• Medical or other issue impacting exercise ability or safety, or ability to comply with study procedures (e.g. significant vision or cognitive impairment, major illness, in hospital or other institution), and specifically:

• Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g. myocardial infarction, target-vessel revascularization, coronary bypass surgery, stroke or blood clot) or other major medical condition (as determined by an investigator) that may put the subject at risk because of his/her participation in the study;
• Have an implanted cardiac pacemaker or other implanted cardiac device;
• Have chronic, uncontrolled hypertension as judged by the investigator;
• Have a creatinine clearance < 45 mL/min as calculated by the Cockcroft-Gault equation;
• Subject's hand or legs have mobility impairment from fractures, arthritis, surgery, muscle disease or other injury that may interfere with any study procedure or ability to exercise

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Syrjala

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Julie Gralow

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Marie-Laure Crouch

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2018-00544

Identifier Type: REGISTRY

Identifier Source: secondary_id

9988

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9988

Identifier Type: -

Identifier Source: org_study_id