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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05978960
Acronym
EXERT-BCN
Enrollment
44
Registered
2023-08-07
Start date
2023-05-20
Completion date
2024-09-19
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, nutrition, body composition

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.

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.

Interventions

OTHERNutrition 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis3 monthsMeasurement on bioimpedance analysis machine (Inbody 970)
Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via ultrasound3 monthsMeasurement via ultrasound and calculation with Jackson-Pollack calculations

Secondary

MeasureTime frameDescription
Determine changes in Patient Health Questionnaire-9 (PHQ9) depression score from before to after the nutrition and exercise regimen3 monthsPatient Health Questionnaire-9 total score for the 9 questions ranges from 0 (no depression) to 27 (highest level of depression). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of not at all, several days, more than half the days, and nearly every day, respectively. Higher scores mean a worse outcome.
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 regimen3 monthsEuroQol-5 Dimensions-5 Levels total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). This is calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to, respectively. Higher scores mean worse outcomes.
Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen3 monthsLoad is calculated by multiplying sets by repetitions by weight lifted for a specific exercise
Determine changes in bone mineral concentration in pounds from before to after the nutrition and exercise regimen3 monthsMeasurement on bioimpedance analysis machine (Inbody 970)
Determine changes in overall score of Functional Movement Screen (FMS) from before to after the nutrition and exercise regimen3 monthsFunctional movement screen (FMS) total score for the 7 movement patterns assessed by an examiner ranges from 0 to 21. A score below 14 is felt to identify individuals at risk of injury. This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum) to the response categories of if any pain felt by the subject during the movement, subject is unable to perform the movement, subject performs the movement through compensatory movements, and subject performs the movement correctly, respectively. A score below 14 is felt to identify individuals at risk of injury. Higher scores mean a better outcome.
Determine changes in resting metabolic rate in kilocalories/day from before to after the nutrition and exercise regimen3 monthsMeasurement via VO2 Master indirect calorimeter
Determine changes in muscle mass in pounds from before to after the nutrition and exercise regimen3 monthsMeasurement on bioimpedance analysis machine (Inbody 970)
Determine changes in Y-balance score for each leg3 monthsY-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.
Determine changes in General Anxiety Disorder-7 (GAD7) anxiety score from before to after the nutrition and exercise regimen3 monthsGeneral Anxiety Disorder-7 total score for the seven questions ranges from 0 (no anxiety) to 21 (highest level of anxiety). This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum), to the response categories of not at all, several days, more than half the days, and nearly every day, respectively. Higher scores mean a worse outcome.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026