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

Breast Cancer Clinical Trial

— EXERT-BCN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978960
• Other study ID #: 2023-131-SG
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: August 20, 2024

Study information

• Verified date: July 2023
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: Samantha Campbell
• Phone: (412) 330-6151
• Email: samantha.campbell[@]ahn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	AHN CI Exercise Oncology and Resiliency	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Erratum In: JAMA. 2018 Apr 3;319(13):1386. JAMA. 2018 Apr 24;319(16):1728. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Determine changes in bone mineral concentration in pounds from before to after the nutrition and exercise regimen	Measurement on bioimpedance analysis machine (Inbody 970)	3 months
Secondary	Determine changes in GAD7 anxiety score from before to after the nutrition and exercise regimen	GAD7 asks 8 questions rated from 0 to 3	3 months
Secondary	Determine changes in PHQ9 depression score from before to after the nutrition and exercise regimen	PHQ9 asks 10 questions rated from 0 to 3	3 months
Secondary	Determine changes in EQ-5D responses 1-5 and overall score from before to after the nutrition and exercise regimen	EQ-5D asks 5 questions rates from 1-5 and an overall rating of health	3 months
Secondary	Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen	Load is calculated by multiplying sets by repetitions by weight lifted for a specific exercise	3 months
Secondary	Determine changes in Y-balance score for each leg	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
Secondary	Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen	Functional movement screen (FMS) is a 7 movement test where an individual can score from 0 to 21	3 months
Secondary	Determine changes in resting metabolic rate in kilocalories/day from before to after the nutrition and exercise regimen	Measurement via VO2 Master indirect calorimeter	3 months
Secondary	Determine changes in muscle mass in pounds from before to after the nutrition and exercise regimen	Measurement on bioimpedance analysis machine (Inbody 970)	3 months