Clinical trial NCT03760536: Get REAL and HEEL Research Program
Official title: Get REAL and HEEL Research Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential study participants with confirmed early-stage breast cancer will be screened through a review of daily clinic schedules for patients seen at the North Carolina Cancer Hospital. Patients must have recently completed their initial treatment (be within one year of completion).

Brief summary: The UNC Get REAL \& HEEL (GR\&H) program has provided after treatment support for women with a breast cancer diagnosis since 2006. The 16-week program includes an individualized training program and the opportunity to continue working out in the GR\&H facilities at the conclusion of the 16-week program. The purpose of this protocol is to implement a research agenda at GR\&H that will examine the efficacy of the program. The primary aim of this study is a pre-post test of the impact of the GR\&H program (standardized combination of aerobic and resistance training) on VO2peak1,2. The secondary aims of this study are to evaluate quality of life as well as cardiorespiratory function (vascular health), physical function (muscular strength, body composition), cognition, balance, and patient-reported outcomes (fatigue, depression, anxiety, quality of life). Exploratory aims are focused on evaluating the impact of exercise on biomarkers: (1) aging - p16INK4a, (2) immune cell function - total leukocyte count, T and natural killer cells, monocytes, and neutrophils count and activity, and (3) circulating pro- and anti-inflammatory cytokines.

Detailed description: Objectives:

Primary:

Evaluate the impact of the Get REAL and HEEL research program (standardized combination of aerobic and resistance training) on change in V02peak from pre to post 16-week intervention.

Secondary:

Evaluate the impact of the GR\&H program (standardized combination of aerobic and resistance training) on change in cardiorespiratory function, immunology, physical function parameters, cognition, balance, and patient-reported outcomes from pre to post 16-week intervention.

Evaluate changes in all measures annually over the 5 year follow-up period.

Report on enrollment, recruitment, and attrition.

Exploratory Objectives

The investigator's exploratory aims are focused on evaluating the impact of exercise on biomarkers: (1) aging - p16INK4a, (2) total leukocyte, lymphocyte (T cells and natural killer cells), monocyte and neutrophil counts and T cell proliferation assays, natural killer cytotoxicity assays, and cytokine production from stimulated neutrophils and monocytes, and (3) circulating pro- and anti-inflammatory cytokines.

OUTLINE:

Participants will complete pre-intervention assessments, questionnaires and blood draw at week 1 and 2 pre-intervention, followed by a 16-week aerobic and resistance training exercise program (intervention). Participants will complete assessments, questionnaires and blood draws at week 1 and 2 following the intervention and then again at 6 months and 12 months following intervention. Questionnaires only will be administered at year 2, 3,4 and 5 following intervention.

Eligibility criteria: Inclusion Criteria:

Patients will be eligible for this protocol if they have

* histologically confirmed early stage (non-metastatic) breast cancer
* and have recently (within 1 year) completed their initial treatment (they may continue to be on endocrine treatment).

No exclusions will be made based on ethnicity or race, although patients must be able to read and speak English.

Participants must provide IRB-approved signed written informed consent. The consent includes access to their medical records, including demographic and billing information, diagnoses, treatments, and laboratory results. Participants may also be asked to provide permission to contact their non-UNC doctors for additional medical record information, and may also require a medical release from various treating physicians.

Interested persons must agree to adhere to the 16-week GR\&H protocol and complete all blood draws, assessments and questionnaires to the best of their ability. The informed consent will also include annual follow-up assessments and questionnaires for up to 5 years after they have completed the 16-week program.

Patients who are approached about participating in LCCC1630 and decline to do so are able to join GR\&H as a supportive care program.

Exclusion Criteria:

Interested persons will be excluded from study participation if

* they do not have evidence of a cancer diagnosis or completion of surgery, radiation and/or chemotherapy treatment,
* or if they have previously completed the GR\&H exercise program. Entirely at the discretion of GR\&H investigators, physical function and other assessments conducted at baseline may also determine that a patient is not medically suitable for the GR\&H protocol. Consented patients who are determined to be medically not suited for the GR\&H protocol (unevaluable) will remain in the study for analyses comparing those who are evaluable with those who are not.

Primary outcomes:
measure: Cardiopulmonary exercise test with NIRS and PWA (vascular function)
timeFrame: Pre-intervention (weeks 1-2), Post-intervention (weeks 17 or 18), 6 months post-intervention, 12-months post intervention
Secondary outcomes:
measure: Anthropometrics-Height
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
measure: Anthropometrics-Weight
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
measure: Anthropometrics-BMI
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
measure: Anthropometrics-Blood Pressure
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
measure: Anthropometrics-Resting Heart Rate
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
measure: Body Composition
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post-intervention, 12 months post-intervention
measure: Measure of muscle composition -- proportion of body fat to lean muscle mass
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Vascular Function
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Resting ECG
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Functional Tests
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Functional Tests
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Cognitive Testing
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Cognitive Testing
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Cognitive Testing
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Cognitive Testing
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Cognitive Testing
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Cognitive Testing
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Muscle Strength and Power
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Blood Draw
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Satisfaction with GR&H Questionnaire
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
measure: Acute exercise bout with blood draw for immune/inflammatory parameters (subset group only)
timeFrame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Cancer Hospital
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Claudio L Battaglini, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Kirsten Nyrop
role: STUDY_DIRECTOR
References:
citation: Wagoner CW, Lee JT, Hanson ED, Kerr ZY, Nyrop KA, Muss HB, Battaglini CL. Baseline fatigue in early breast cancer survivors: understanding its prevalence in community-based exercise. Support Care Cancer. 2022 May;30(5):4407-4416. doi: 10.1007/s00520-021-06776-8. Epub 2022 Jan 31.
citation: Bartlett DB, Hanson ED, Lee JT, Wagoner CW, Harrell EP, Sullivan SA, Bates LC, Alzer MS, Amatuli DJ, Deal AM, Jensen BC, MacDonald G, Deal MA, Muss HB, Nyrop KA, Battaglini CL. The Effects of 16 Weeks of Exercise Training on Neutrophil Functions in Breast Cancer Survivors. Front Immunol. 2021 Oct 27;12:733101. doi: 10.3389/fimmu.2021.733101. eCollection 2021.
citation: Hanson ED, Bates LC, Harrell EP, Bartlett DB, Lee JT, Wagoner CW, Alzer MS, Amatuli DJ, Jensen BC, Deal AM, Muss HB, Nyrop KA, Battaglini CL. Exercise training partially rescues impaired mucosal associated invariant t-cell mobilization in breast cancer survivors compared to healthy older women. Exp Gerontol. 2021 Sep;152:111454. doi: 10.1016/j.exger.2021.111454. Epub 2021 Jun 16.