Clinical trial NCT04208074: Exercise Study for Breast Cancer Survivors
Official title: Enhancing Muscle Strength and Immunity in Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Exercise
Resistance Exercise
T cells
Immune system
Lead sponsor: San Diego Biomedical Research Institute
Sponsor class: OTHER
Collaborators: name: California Breast Cancer Research Program
name: Arizona State University
name: Tri-City Wellness & Fitness Center
name: We Support U
First posted: 2019-12-23
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the link between muscle health and immune health in breast cancer survivors. Regular exercise is known to improve overall survival in cancer patients but the mechanism is not known. In this study the investigators will evaluate if improving muscle mass and strength via exercise improves the immune system's ability to fight cancer.

This is a one armed study where in 30 breast cancer survivors will be recruited to a 4 month exercise intervention. Increase in muscle mass and strength will be correlated with immune cell frequency and function.

Detailed description: Breast cancer survivors with stronger and larger muscles have better overall survival and lower recurrence than women with weaker and smaller muscles. However, the mechanism for this association is currently unknown. A recent study from the investigators has shown that there is an association between the frequency of immune cell types that kill cancer and higher muscle mass and strength, with higher muscle mass and strength correlating with a higher frequency of cancer killing, effector memory, T cells. The investigators thus propose that increasing muscle mass and strength can improve overall survival and reduce recurrence by increasing the number of cancer killing immune T cells.

To test this hypothesis, the investigators will recruit 30 breast cancer survivors to an exercise program designed to increase their muscle mass and strength. The program will be optimized to each participant's level of fitness and strength and will be designed by experts in the field. Personal trainers will teach the participants how to exercise and use muscle resistance training equipment using the correct technique and will monitor progress to avoid injuries and to maximize training benefits.

The investigators will collect blood (to study immune cell subsets) and measure muscle strength and body composition (to measure muscle mass) for participants before and after the study.

The duration of the exercise training protocol is 4 months and participants will be asked to exercise 4 days a week; 2 days at the gym and 2 days at home.

Eligibility criteria: Inclusion Criteria:

* Women
* Post menopausal
* Stage I - III breast cancer
* Breast cancer the only cancer
* Can exercise for 16 weeks; 2 days a week at the gym and 2 days of the week at home
* Live in the San Diego area

Exclusion Criteria:

* Exercise regularly in the gym.
* Are on chemotherapy or radiation therapy or have been in the past month
* Will be on chemotherapy or radiation therapy in the next 6 months
* Have a condition that will prevent them from exercising in the gym

Primary outcomes:
measure: Change in frequency of effector memory immune cells
timeFrame: 16 weeks of muscle resistance training
measure: Change in frequency of central memory immune cells
timeFrame: 16 weeks of muscle resistance training
measure: Change in frequency of regulatory immune cells
timeFrame: 16 weeks of muscle resistance training
measure: Change muscle mass
timeFrame: 16 weeks of muscle resistance training
measure: Change in hand grip strength
timeFrame: 16 weeks of muscle resistance training
measure: Change in capacity to climb stairs
timeFrame: 16 weeks of muscle resistance training
measure: Change in upper body strength
timeFrame: 16 weeks of muscle resistance training
measure: Change in lower body strength
timeFrame: 16 weeks of muscle resistance training
measure: Change in levels of inflammatory factors in the blood
timeFrame: 16 weeks of muscle resistance training
measure: Change in levels of factors called microRNAs in the blood
timeFrame: 16 weeks of muscle resistance training
Secondary outcomes:
measure: Body Mass Index
timeFrame: 1 day before, and 1 day after the 16 week muscle resistance training program
measure: Physical activity
timeFrame: 1 day before, and 1 day after the 16 week muscle resistance training program
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Aditi Narsale
state: California
Study officials:
affiliation: San Diego Biomedical Research Institute
name: Joanna D Davies, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Narsale A, Moya R, Ma J, Anderson LJ, Wu D, Garcia JM, Davies JD. Cancer-driven changes link T cell frequency to muscle strength in people with cancer: a pilot study. J Cachexia Sarcopenia Muscle. 2019 Aug;10(4):827-843. doi: 10.1002/jcsm.12424. Epub 2019 Apr 12.