Clinical trial NCT05747209: EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast CA
Official title: Prospective Study of an EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females aged 20-89 years with newly diagnosed ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast who have undergone and completed treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy.

Brief summary: The goal of this clinical trial is to learn how a group resistance training plan can improve body mobility and strength in female breast cancer patients who have completed their breast cancer treatment. The main questions it aims to answer are:

* Is resistance training feasible following breast cancer treatment
* Can it improve the body's mobility and strength lost as a result of the breast cancer treatment
* can it improve the body's composition (for example muscle mass)
* can resistance training increase one's activity level and help prevent weight gain, perhaps, lowering the risk of cancer recurrence.

Participants will attend a group resistance training exercise group program, 3-4 times per week, under close supervision with monitoring a participant's ability to safely and effectively complete the program. The exercises include: lunges, squats and dead lifts.

Detailed description: Obesity and low muscle mass, i.e. poor body composition, is a risk factor for breast cancers and disease recurrence after treatment. Furthermore, weight gain during and after treatment for breast cancer is associated with higher risk of recurrence, distant metastases, and death. Activity levels have been repeatedly associated with a lower risk of cancer incidence, improved outcomes after cancer treatment and improved overall survival, yet the majority of breast cancer survivors do not meet adequate daily activity level recommendations.

This protocol seeks to prospectively follow forty (40) female breast cancer patients (ages 20-95) during exercise who are post-cancer treatment and to assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment. This regimen is a standard of care regimen utilized in strength and conditioning protocols. The investigators hypothesize that an observed exercise regimen such as this will prove safe and feasible in women and may improve functional mobility, body composition and resting metabolic rate.

The exercise regimen will utilize a mixture of compound movements utilizing mainly closed kinetic chain movements (CKC), focusing on exercises with the goal of improving physical and metabolic function, mobility, muscle mass and body composition utilizing guidelines from the National Strength and Conditioning Association (NSCA). CKC exercises include lunges, squats, and dead lifts.

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 breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
4. Participants must have abstained from smoking for at least 12 months
5. Women of child-bearing potential must have had a pregnancy test prior to initiation of radiation therapy (standard protocol for radiation therapy); verbally confirm lack of pregnancy prior to enrollment; and, consent to use adequate contraception during the course of the study.
6. Participants must be determined capable of engaging in resistance training.
7. Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
8. Participants must complete a Functional Mobility Screen (FMS) and be determined safe to engage in the workout regimen by the study exercise personnel.
9. Participants must be determined capable of engaging in group resistance training sessions by exercise personnel and/or study PI
10. Participants must be able to get down and up from the ground and squat their body weight.

Exclusion Criteria:

1. Any 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

Primary outcomes:
measure: Session Attendance
timeFrame: Three (3) months
measure: Adipose Tissue in pounds
timeFrame: 3 months
measure: Adipose Tissue in pounds
timeFrame: 3 months
measure: Muscle Mass in pounds
timeFrame: 3 months
measure: Muscle Mass in pounds
timeFrame: 3 months
measure: Quality of Life via the EuroQol Group survey EQ5D
timeFrame: 3 months
measure: Activity Levels via Godin Questionnaire
timeFrame: 3 months
measure: Resting Metabolic Rate as calories burned per day
timeFrame: 3 months
measure: Resting Metabolic Rate as calories burned per day
timeFrame: 3 months
measure: Functional Movement Screen
timeFrame: 3 months
measure: Balance
timeFrame: 3 months
measure: Strength
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: AGH Radiation Oncology
name: Colin Champ, MD
role: PRINCIPAL_INVESTIGATOR
References: