Clinical trial NCT05978960: EXERT-BCN: an Exercise and Nutrition Regimen to Designed to Improve Body Composition After Treatment for Breast Cancer
Official title: An EXErcise Regimen Designed to Improve Body Composition, Functional Capacity, and Strength After Treatment for Breast Cancer with Nutrition Optimization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
nutrition
body composition
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis
timeFrame: 3 months
measure: Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via ultrasound
timeFrame: 3 months
Secondary outcomes:
measure: Determine changes in bone mineral concentration in pounds from before to after the nutrition and exercise regimen
timeFrame: 3 months
measure: Determine changes in General Anxiety Disorder-7 (GAD7) anxiety score from before to after the nutrition and exercise regimen
timeFrame: 3 months
measure: Determine changes in Patient Health Questionnaire-9 (PHQ9) depression score from before to after the nutrition and exercise regimen
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen
timeFrame: 3 months
measure: Determine changes in Y-balance score for each leg
timeFrame: 3 months
measure: Determine changes in overall score of Functional Movement Screen (FMS) from before to after the nutrition and exercise regimen
timeFrame: 3 months
measure: Determine changes in resting metabolic rate in kilocalories/day from before to after the nutrition and exercise regimen
timeFrame: 3 months
measure: Determine changes in muscle mass in pounds from before to after the nutrition and exercise regimen
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: AHN CI Exercise Oncology and Resiliency
state: Pennsylvania
Study officials:
References:
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.
citation: 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.