Get REAL and HEEL Research Program

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03760536

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

35

Starts

2017-03-20

Expected to finish

2020-02-12

Last updated by the study team

2021-09-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• North Carolina Cancer Hospital — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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