Breast Cancer Clinical Trial
Official title:
Get REAL and HEEL Research Program
NCT number | NCT03760536 |
Other study ID # | LCCC 1630 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 20, 2017 |
Est. completion date | February 12, 2020 |
Verified date | September 2021 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | February 12, 2020 |
Est. primary completion date | March 9, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | North Carolina Cancer Hospital | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiopulmonary exercise test with NIRS and PWA (vascular function) | 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. | Pre-intervention (weeks 1-2), Post-intervention (weeks 17 or 18), 6 months post-intervention, 12-months post intervention | |
Secondary | Anthropometrics-Height | Measure Height | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | |
Secondary | Anthropometrics-Weight | Weight | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | |
Secondary | Anthropometrics-BMI | Measure BMI | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | |
Secondary | Anthropometrics-Blood Pressure | Measure blood pressure -- both systolic and diastolic | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | |
Secondary | Anthropometrics-Resting Heart Rate | Measure Resting Heart Rate | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention | |
Secondary | Body Composition | 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). | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post-intervention, 12 months post-intervention | |
Secondary | Measure of muscle composition -- proportion of body fat to lean muscle mass | 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. | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Vascular Function | XCEL Sphygmacor+USCOM | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Resting ECG | 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. | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Functional Tests | 6-minute walk | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Functional Tests | Timed Up and Go | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Cognitive Testing | Administer DKEFS | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Cognitive Testing | Administer Digit Span | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Cognitive Testing | Administer Sequencing | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Cognitive Testing | Administer HVLT-R | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Cognitive Testing | Administer TMT | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Cognitive Testing | Administer NeuroCom balance test | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Muscle Strength and Power | Isokinetic, isometric handgrip tests | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Blood Draw | 30 mL Blood draw for non-subset group | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Satisfaction with GR&H Questionnaire | Administer Satisfaction with GR&H Questionnaire | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention | |
Secondary | Acute exercise bout with blood draw for immune/inflammatory parameters (subset group only) | 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 | Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention |
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