EXERT-BCN: An Exercise and Nutrition Regimen to Designed to Improve Body Composition After Treatment for Breast Cancer (EXERT-BCN)

July 31, 2023 updated by: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

An EXErcise Regimen Designed to Improve Body Composition, Functional Capacity, and Strength After Treatment for Breast Cancer With Nutrition Optimization

This protocol seeks to analyze patient outcomes of the standard of care, monitored group exercise regimen of high-load resistance training and functional exercises with compound movements in conjunction with a nutrition regimen focused on food quality under close supervision on women who have been treated for breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Excess adipose tissue is a risk factor for the diagnosis of breast cancer and is also associated with an increased risk of disease recurrence.1 Additionally weight gain during and after treatment for breast cancer is associated with a higher risk of recurrence, distant metastases, and death.2 More specifically, low muscle mass and increased adipose tissue is associated with poorer outcomes after the treatment of breast cancer.3 Yet, most women gain significant weight during and after breast cancer treatment, potentially compromising outcomes.

Effective methods to promote weight loss and improve metabolic and hormonal dysregulation, inflammation, and body composition in the breast cancer setting are urgently needed. In the noncancer setting, the promotion of high-quality diets that avoided processed food and simple carbohydrates in the DIETFITS study promoted weight loss4. However, this dietary strategy and others were utilized to result in weight loss, but do not necessarily consider maximizing body composition, i.e., muscle mass preservation or increase, and adipose tissue loss.

The major, and some would consider only, non-pharmacological method to increase muscle mass is via resistance training with an adequate stimulus and quantity to elicit and promote hypertrophy.5 Our group has already shown that profound muscle hypertrophy is attainable in a population of women undergoing treatment for breast cancer, particularly when the dose threshold of load and repetitions is met. At interim analysis, this program revealed a 2 lb. increase in muscle mass and a 6 lb. decrease in adipose tissue after a 3 month program utilizing linear progression.

Based on the DIEFITS protocol which has been described as a "healthy low-carbohydrate" diet, participants will be advised to eat nutrient dense food sources high in vitamins, minerals, and nutrients. Participants will be told to limit processed foods, sugar, bread, pasta, and other simple carbohydrates. Participants will be advised to eat plenty of colorful and nonstarchy vegetables. Finally, participants will be told to avoid snacking between meals, cook most/all meals, eat with family and friends, avoid eating food in the car or on the run, and focus on whole foods that require preparation. This protocol resulted in significant weight loss at one year. Additionally, the lack of calculations and quantification of calories leaves this as a more user-friendly option for participants.

The exercise regimen from EXERT-BC has yet to be combined with a dietary intervention. Thus, the following protocol will assess our resistance training regimen in conjunction with a nutrition intervention similar to the DIETFITS Protocol. This will allow adequate assessment of whether we can optimize body composition in these individuals with both exercise and dietary changes.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15202
        • Recruiting
        • AHN CI Exercise Oncology and Resiliency
        • Contact:
        • Principal Investigator:
          • Colin E Champ, MD, CSCS
        • Sub-Investigator:
          • Christopher L Peluso, MS, CSCS
        • Sub-Investigator:
          • Christie Hilton, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 20-89 years
  2. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast.
  3. Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Treatment with targeted agents and immunotherapy is allowed.

Exclusion Criteria:

  1. Any current treatment with chemotherapy for breast cancer
  2. Inability to get and down off the ground or squat body weight
  3. Inability to safely engage in group sessions
  4. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance training with high quality low-carbohydrate nutrition regimen
The regimen will consist of an intense resistance training program with linear progression and the goal of increase strength, mobility, muscle mass, and functional capacity. The nutrition program will avoid calorie counting, and instead focus on quality, while maximizing protein and limiting carbohydrates.
Other: Nutrition and resistance training exercise intervention

3 month 2-3 times/week, 60 min exercise regimen utilizes compound movements to focus on body composition, strength, and mobility. Classes are run by certified strength and conditioning specialists and adjusted for linear progression and safety, progressing from compound to isolated movements to maximize safety.

The nutrition intervention focuses on dietary quality by following a "healthy low-carbohydrate" diet, focusing on nutrient dense foods high and avoiding processed foods and simple carbohydrates to keep totals under 100g/day. Participants will be advised to eat vegetables, avoid snacking, cook all meals with family and friends, avoid eating on the run, and focus on whole foods that require preparation. Calculations and quantification of calories will be avoided, while protein consumption goals are 1.3-1.8 g/kg per. Dietary strategy will be continuously discussed during exercise sessions and the PI will have twice monthly meetings with participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis
Time Frame: 3 months
Measurement on bioimpedance analysis machine (Inbody 970)
3 months
Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via ultrasound
Time Frame: 3 months
Measurement via ultrasound and calculation with Jackson-Pollack calculations
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine changes in bone mineral concentration in pounds from before to after the nutrition and exercise regimen
Time Frame: 3 months
Measurement on bioimpedance analysis machine (Inbody 970)
3 months
Determine changes in GAD7 anxiety score from before to after the nutrition and exercise regimen
Time Frame: 3 months
GAD7 asks 8 questions rated from 0 to 3
3 months
Determine changes in PHQ9 depression score from before to after the nutrition and exercise regimen
Time Frame: 3 months
PHQ9 asks 10 questions rated from 0 to 3
3 months
Determine changes in EQ-5D responses 1-5 and overall score from before to after the nutrition and exercise regimen
Time Frame: 3 months
EQ-5D asks 5 questions rates from 1-5 and an overall rating of health
3 months
Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen
Time Frame: 3 months
Load is calculated by multiplying sets by repetitions by weight lifted for a specific exercise
3 months
Determine changes in Y-balance score for each leg
Time Frame: 3 months
Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk.
3 months
Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen
Time Frame: 3 months
Functional movement screen (FMS) is a 7 movement test where an individual can score from 0 to 21
3 months
Determine changes in resting metabolic rate in kilocalories/day from before to after the nutrition and exercise regimen
Time Frame: 3 months
Measurement via VO2 Master indirect calorimeter
3 months
Determine changes in muscle mass in pounds from before to after the nutrition and exercise regimen
Time Frame: 3 months
Measurement on bioimpedance analysis machine (Inbody 970)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2023

Primary Completion (Estimated)

May 20, 2024

Study Completion (Estimated)

August 20, 2024

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-131-SG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Undecided at this point

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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