Clinical trial NCT03523195: Exercise Intervention After Cancer Treatment for Improving Health in Stage II-III Breast Cancer Survivors
Official title: Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Adherence
timeFrame: Up to 26 weeks
measure: Differential micro ribonucleic acid expression
timeFrame: At baseline, 13, and 26 weeks
Secondary outcomes:
measure: 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
timeFrame: Up to 26 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Karen Syrjala
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Julie Gralow
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Marie-Laure Crouch
role: PRINCIPAL_INVESTIGATOR
References: