NCT03523195

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

Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Intervention	Complete exercise program
OTHER	Informational Intervention	Receive written information on healthy exercise and diet recommendations
OTHER	Laboratory Biomarker Analysis	Blood tests
DEVICE	Monitoring Device	Wear Fitbit
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Physical Performance Testing	Performance of physical tests

Timeline

• Start date: 2018-04-18
• Primary completion: 2019-07-15
• Completion: 2019-07-15
• First posted: 2018-05-14
• Last updated: 2019-07-22

Locations

1 site across 1 country: United States