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

NCT05978960 | Completed DMC

• 1 other identifier: 2023-131-SG
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer; nutrition; body composition

Outcome Measures

Primary Outcomes (2)

• Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis

  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

  Measurement via ultrasound and calculation with Jackson-Pollack calculations

  3 months

Secondary Outcomes (9)

• Determine changes in bone mineral concentration in pounds from before to after the nutrition and exercise regimen

  3 months

• Determine changes in General Anxiety Disorder-7 (GAD7) anxiety score from before to after the nutrition and exercise regimen

  3 months

• Determine changes in Patient Health Questionnaire-9 (PHQ9) depression score from before to after the nutrition and exercise regimen

  3 months

• Determine changes in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) responses 1-5 and overall score from before to after the nutrition and exercise regimen

  3 months

• Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen

  3 months

Study Arms (1)

Resistance training with high quality low-carbohydrate nutrition regimen

EXPERIMENTAL

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

Interventions

Nutrition and resistance training exercise intervention OTHER

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.

Resistance training with high quality low-carbohydrate nutrition regimen

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-89 years
• Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

AHN CI Exercise Oncology and Resiliency

Pittsburgh, Pennsylvania, 15202, United States

Location

Related Publications (2)

• Gardner CD, Trepanowski JF, Del Gobbo LC, Hauser ME, Rigdon J, Ioannidis JPA, Desai M, King AC. Effect of Low-Fat vs Low-Carbohydrate Diet on 12-Month Weight Loss in Overweight Adults and the Association With Genotype Pattern or Insulin Secretion: The DIETFITS Randomized Clinical Trial. JAMA. 2018 Feb 20;319(7):667-679. doi: 10.1001/jama.2018.0245.

  PMID: 29466592 BACKGROUND

• Champ CE, Carpenter DJ, Diaz AK, Rosenberg J, Ackerson BG, Hyde PN. Resistance Training for Patients with Cancer: A Conceptual Framework for Maximizing Strength, Power, Functional Mobility, and Body Composition to Optimize Health and Outcomes. Sports Med. 2023 Jan;53(1):75-89. doi: 10.1007/s40279-022-01759-z. Epub 2022 Sep 29.

  PMID: 36175646 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: May 20, 2023
• Primary Completion: July 4, 2024
• Study Completion: September 19, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)