Exercise Study for Breast Cancer Survivors

NCT04208074 | Unknown

• 1 other identifier: 25IB-0023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Exercise; Resistance Exercise; T cells; Immune system

Outcome Measures

Primary Outcomes (10)

• Change in frequency of effector memory immune cells

  Effector memory cells are immune cells that can kill cancer. We will measure the frequency of these cells before and after the 16 week training program to see if they increase. Flow Cytometry techniques will be used to determine the frequency of these cells.

  16 weeks of muscle resistance training

• Change in frequency of central memory immune cells

  Central memory cells are immune cells that are linked to poor prognosis in patients with cancer. We will measure the frequency of these cells before and after the 16 week training program to see if they decrease. Flow Cytometry techniques will be used to determine the frequency of these cells.

  16 weeks of muscle resistance training

• Change in frequency of regulatory immune cells

  Regulatory immune cells, also called Tregs, are a type of immune cell that keeps the immune system from becoming over active. However, people with too many Treg cells might be more susceptible to cancer growth. We will measure the frequency of Tregs by Flow Cytometry before and after the 16 week training program to see if exercise reduces their frequency.

  16 weeks of muscle resistance training

• Change muscle mass

  Dual energy x-ray absorptiometry (DEXA) scans will be used to measure the appendicular muscle mass (amount of muscle in the arms and legs) before and after the 16 week training program. The appendicular muscle mass index is calculated using the appendicular muscle mass divided by height square and is measured in kg/m\^2.

  16 weeks of muscle resistance training

• Change in hand grip strength

  The level of hand grip strength is a good indicator of body strength. Hand grip strength will be measured in kilograms using an instrument called a dynamometer before and after the 16 week training program.

  16 weeks of muscle resistance training

• Change in capacity to climb stairs

  The stair climb test measures the amount of power used by a participant to climb a set of stairs. Power is measured in Watts (W) and is calculated using the time taken to climb the stairs (seconds), the vertical height of the stairs (meters) and the weight (kilograms) of the participant and is a standard measure of performance. The stair climb test will be performed before and after the 16 week training program.

  16 weeks of muscle resistance training

• Change in upper body strength

  The Chest Press Test will be used to measure upper body strength. It will be performed before and after the 16 week training program using specialized exercise equipment in the gym. This test will measure the maximum weight that be lifted by the arms and will be measured in kilograms.

  16 weeks of muscle resistance training

• Change in lower body strength

  The Knee Extension Test will be used as a measure of lower body strength. It will be performed before and after the 16 week training program using specialized exercise equipment in the gym. This test will measure the maximum weight that be lifted by the legs and will be measured in kilograms.

  16 weeks of muscle resistance training

• Change in levels of inflammatory factors in the blood

  The investigators will measure the levels of inflammatory and anti-inflammatory factors, called cytokines, in blood collected before and after the 16 week training program. Cytokines will be measured in picograms per milliliter.

  16 weeks of muscle resistance training

• Change in levels of factors called microRNAs in the blood

  The investigators will measure levels of microRNAs in the blood before and after the 16 week training protocol. The microRNAs will be detected and levels measured using a technique called qPCR.

  16 weeks of muscle resistance training

Secondary Outcomes (2)

• Body Mass Index

  1 day before, and 1 day after the 16 week muscle resistance training program

• Physical activity

  1 day before, and 1 day after the 16 week muscle resistance training program

Study Arms (1)

Exercise

EXPERIMENTAL

Four months of muscle resistance training (exercise) designed to increase muscle mass and strength. The exercise protocol includes four different lifts with weights including, squats, bench press, dead lift and overhead press. The weights for each lift will be optimized for each participant and increased as the participant adapts to the exercise routine.

Other: Exercise Intervention

Interventions

Exercise Intervention OTHER

Participants will exercise under the supervision of expert personal trainers and follow an optimized exercise program tailored to the strength and fitness level of each participant. Participants will exercise for 16 weeks; 2 days a week at the gym for an hour and 2 days of the week at home for 45 minutes.

Exercise

Eligibility Criteria

• Gender Eligibility Details: Since very few men are diagnosed with breast cancer study, women previously diagnosed with breast cancer will be the only group eligible.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego Biomedical Research Institute: lead
• California Breast Cancer Research Program: collaborator
• Arizona State University: collaborator
• Tri-City Wellness & Fitness Center: collaborator
• We Support U: collaborator

Study Sites (1)

Aditi Narsale

San Diego, California, 92121, United States

Location

Related Publications (1)

• 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.

  PMID: 30977974 BACKGROUND

Related Links

• Information about the study on the official San Diego Biomedical Research Institute website
• Visit us at the link above for more information about the study

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Joanna D Davies, PhD

  San Diego Biomedical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President and CEO, Professor

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 23, 2019
• Study Start: November 25, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)