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

Sedentary Lifestyle Clinical Trial

— PACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523195
• Other study ID #: 9988
• Secondary ID: NCI-2018-0054499
• Status: Completed
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: July 2019
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• 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
• Breast Neoplasms
• 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

Intervention

Behavioral:
• Exercise Intervention
Complete exercise program

Other:
• Informational Intervention
Receive written information on healthy exercise and diet recommendations
• Laboratory Biomarker Analysis
Blood tests

Device:
• Monitoring Device
Wear Fitbit

Other:
• Questionnaire Administration
Ancillary studies
• Physical Performance Testing
Performance of physical tests

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Will assess the percent of expected onsite sessions attended by participants as determined by Prevention Center attendance log.	Up to 26 weeks
Primary	Differential micro ribonucleic acid expression	Will compare between arms. Descriptive statistics will be provided. Will calculate the log-fold change between baseline measure and post-baseline measure, and the difference in the log-fold change will be calculated between the two arms.	At baseline, 13, and 26 weeks
Secondary	Percent of expected home exercise sessions completed as determined by the home exercise logs for those choosing to not come in for a third weekly session		Up to 26 weeks