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Get REAL and HEEL Research Program

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ClinicalTrials.gov Identifier: NCT03760536
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: 16-week Exercise Rehabilitation Program for Breast Cancer Survivors

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Get REAL and HEEL Research Program
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
16-week Exercise Program
Interested patients will attend a group meeting where they will be screened and consented to the study. During weeks 1 and 2 patients will complete pre-intervention baseline assessments and blood draws followed by a 16-week supervised exercise program at Get REEL and HEAL facility. Study participants will complete progressive aerobic and resistance exercise training. Post-intervention weeks 1 and 2 participants will complete assessments, questionnaires and blood draws. Participants will be followed up at 6 and 12 months post intervention with physical assessments, questionnaires and blood draws. Annual follow-up will occur at year 2,3,4 and 5 post intervention with questionnaires only.
Behavioral: 16-week Exercise Rehabilitation Program for Breast Cancer Survivors
Interested patients will attend a group meeting where they will be screened and consented to the study. During weeks 1 and 2 patients will complete pre-intervention baseline assessments and blood draws followed by a 16-week supervised exercise program at Get REEL and HEAL facility. Study participants will complete progressive aerobic and resistance exercise training. Post-intervention weeks 1 and 2 participants will complete assessments, questionnaires and blood draws. Participants will be followed up at 6 and 12 months post intervention with physical assessments, questionnaires and blood draws. Annual follow-up will occur at year 2,3,4 and 5 post intervention with questionnaires only.




Primary Outcome Measures :
  1. Cardiopulmonary exercise test with NIRS and PWA (vascular function) [ Time Frame: Pre-intervention (weeks 1-2), Post-intervention (weeks 17 or 18), 6 months post-intervention, 12-months post intervention ]
    The Cardiopulmonary Exercise Test (CPET) with NIRS and PWA will be used to measure peak oxygen content (VO2peak), tissue oxygen saturation and pulse wave analysis during this symptom-limited exercise test.


Secondary Outcome Measures :
  1. Anthropometrics-Height [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention ]
    Measure Height

  2. Anthropometrics-Weight [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention ]
    Weight

  3. Anthropometrics-BMI [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention ]
    Measure BMI

  4. Anthropometrics-Blood Pressure [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention ]
    Measure blood pressure -- both systolic and diastolic

  5. Anthropometrics-Resting Heart Rate [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention ]
    Measure Resting Heart Rate

  6. Body Composition [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post-intervention, 12 months post-intervention ]
    DEXA -- Body Composition will be perfomed using a Hologic (Discovery W) Dual X-ray Absorptiometry (DEXA) located in the EORL. Total body weight-mass (BW) and compositional aspects of lean body mass (LBM), fat tissue mass (FM), and percentage body fat (% BF) will be examined using standard DEXA screening procedures. The BW will be measured using a high grade analytical balance-scale (accuracy ± 10 grams).

  7. Measure of muscle composition -- proportion of body fat to lean muscle mass [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Ultrasound -- LogicView™ software (General Electric Company, Milwaukee, WI, USA) will be used to generate real-time panoramic cross-sectional images of the VL. Three panoramic scans at a gain of 50dB and a depth of 5.0 cm. All image analyses will be completed using Image-J software (version 1.46r, National Institutes of Health, USA) with each image area individually scaled from pixels to centimeters via the straight-line function. The polygon function will be used to determine the CSA of the VL by selecting a region including mostly muscle and minimal surrounding fascia. Greater EI values represent greater fibrous (non-muscular) composition.

  8. Vascular Function [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    XCEL Sphygmacor+USCOM

  9. Resting ECG [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Resting electrocardiogram -- Individual wave/complex/intervals components and overall ECG tracings will be assessed using a 12-lead ECG. The study Cardiologist will review each report individually at baseline prior to the Cardiopulmonary Exercise Test for evidence of overt cardiac dysfunction and will deem the potential study participant appropriate/not appropriate for exercise testing.

  10. Functional Tests [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    6-minute walk

  11. Functional Tests [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Timed Up and Go

  12. Cognitive Testing [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Administer DKEFS

  13. Cognitive Testing [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Administer Digit Span

  14. Cognitive Testing [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Administer Sequencing

  15. Cognitive Testing [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Administer HVLT-R

  16. Cognitive Testing [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Administer TMT

  17. Cognitive Testing [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Administer NeuroCom balance test

  18. Muscle Strength and Power [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Isokinetic, isometric handgrip tests

  19. Blood Draw [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    30 mL Blood draw for non-subset group

  20. Satisfaction with GR&H Questionnaire [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Administer Satisfaction with GR&H Questionnaire

  21. Acute exercise bout with blood draw for immune/inflammatory parameters (subset group only) [ Time Frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention ]
    Cannulated, 3 blood draws over course of 45 minute visit. 50 mL total collected pre-intervention and post intervention; 30 mL total collected at 6 months and 12 months post-intervention


Biospecimen Retention:   Samples With DNA
Blood draw for p16 analysis and immune/inflammatory parameters


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

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): NCT03760536


Contacts
Contact: Kirsten Nyrop, PhD 9199625139 kirsten_nyrop@med.unc.edu
Contact: Amy Garrett, MA 9199660695 amy_garrett@med.unc.edu

Locations
United States, North Carolina
North Carolina Cancer Hospital Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Claudio Battaglini, PhD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Claudio L Battaglini, PhD UNC Lineberger Comprehensive Cancer Center
Study Director: Kirsten Nyrop UNC Lineberger Comprehensive Cancer Center

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03760536     History of Changes
Other Study ID Numbers: LCCC 1630
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No