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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523195
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Exercise Intervention Other: Informational Intervention Other: Laboratory Biomarker Analysis Device: Monitoring Device Other: Questionnaire Administration Other: Physical Performance Testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 0 (written information)
Participants wear Fitbit and receive written information on healthy exercise and diet recommendations.
Other: Informational Intervention
Receive written information on healthy exercise and diet recommendations

Other: Laboratory Biomarker Analysis
Blood tests

Device: Monitoring Device
Wear Fitbit
Other Name: Monitor

Other: Questionnaire Administration
Ancillary studies

Other: Physical Performance Testing
Performance of physical tests
Other Name: Physical Function Testing

Experimental: 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.
Behavioral: Exercise Intervention
Complete exercise program

Other: Laboratory Biomarker Analysis
Blood tests

Other: Questionnaire Administration
Ancillary studies

Other: Physical Performance Testing
Performance of physical tests
Other Name: Physical Function Testing




Primary Outcome Measures :
  1. Adherence [ Time Frame: Up to 26 weeks ]
    Will assess the percent of expected onsite sessions attended by participants as determined by Prevention Center attendance log.

  2. Differential micro ribonucleic acid expression [ Time Frame: At baseline, 13, and 26 weeks ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Up to 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523195


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Karen Syrjala Fred Hutch/University of Washington Cancer Consortium
Principal Investigator: Julie Gralow Fred Hutch/University of Washington Cancer Consortium
Principal Investigator: Marie-Laure Crouch Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03523195    
Other Study ID Numbers: 9988
NCI-2018-00544 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9988 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases