Breast CancerNCT04208074
Exercise Study for Breast Cancer Survivors
A study testing Exercise Intervention in people with Breast Cancer, run by San Diego Biomedical Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Muscle Strength and Immunity in Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Exercise Intervention
- Keywords
- Exercise, Resistance Exercise, T cells, Immune system
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks of muscle resistance training
Secondary outcomes (2)
Body Mass Index
BMI will be calculated using height and weight measurements and reported as kg/m2
Measured: 1 day before, and 1 day after the 16 week muscle resistance training program
Physical activity
Physical activity will be determined using the Framingham Physical activity questionnaire. Overall physical activity will be calculated using the physical index score, with a higher score indicating higher physical activity.
Measured: 1 day before, and 1 day after the 16 week muscle resistance training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start25 Nov 2019
- Primary completionJul 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego Biomedical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- California Breast Cancer Research Program, Arizona State University, Tri-City Wellness & Fitness Center, We Support U
- Responsible party
- Principal investigator, Joanna Davies, San Diego Biomedical Research Institute
- Investigators
- Joanna D Davies, PhD, Principal investigator, San Diego Biomedical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208074
- Sponsor's protocol ID
- 25IB-0023
- Status last verified
- Feb 2020
- First submitted
- 10 Dec 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30977974
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Muscle Strength and Immunity in Breast Cancer
- ClinicalTrials.gov ID
- NCT04208074
- Acronym / sponsor ID
- 25IB-0023
- Conditions
- Breast Cancer
- Keywords
- Exercise, Resistance Exercise, T cells, Immune system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- San Diego Biomedical Research InstituteUniversity, hospital or other
- Collaborators
- California Breast Cancer Research Program, Arizona State University, Tri-City Wellness & Fitness Center, We Support U
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise InterventionFour 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionParticipants 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. | Other | Exercise |
Primary outcome
Change in frequency of effector memory immune cells
Time frame: 16 weeks of muscle resistance training
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.
Change in frequency of central memory immune cells
Time frame: 16 weeks of muscle resistance training
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.
Change in frequency of regulatory immune cells
Time frame: 16 weeks of muscle resistance training
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.
Change muscle mass
Time frame: 16 weeks of muscle resistance training
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.
Change in hand grip strength
Time frame: 16 weeks of muscle resistance training
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.
Change in capacity to climb stairs
Time frame: 16 weeks of muscle resistance training
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.
Change in upper body strength
Time frame: 16 weeks of muscle resistance training
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.
Change in lower body strength
Time frame: 16 weeks of muscle resistance training
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.
Change in levels of inflammatory factors in the blood
Time frame: 16 weeks of muscle resistance training
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.
Change in levels of factors called microRNAs in the blood
Time frame: 16 weeks of muscle resistance training
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.
2 secondary outcomes
Body Mass Index
Time frame: 1 day before, and 1 day after the 16 week muscle resistance training program
Physical activity
Time frame: 1 day before, and 1 day after the 16 week muscle resistance training program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Background: PubMed 30977974Narsale 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.
- Information about the study on the official San Diego Biomedical Research Institute websiteLink provided by the sponsor.
- Visit us at the link above for more information about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna D Davies, PhD principal investigator
San Diego Biomedical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Breast Cancer, run by San Diego Biomedical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of effector memory immune cells (time frame: 16 weeks of muscle resistance training). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.