Female Breast CancerEMBRACENCT05000502
Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations
A study testing Home-based exercise intervention in people with Female Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Understanding the impact exercise has on a cancer survivor's gut microbiome can improve the health and well-being of cancer survivors by enhancing treatments targeting the gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Female Breast Cancer
- What is being tested?
- Home-based exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Jan 2024
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-Hispanic white or black women
- Age 18-70 years
- History of breast cancer stage 0, I, II, or III
- ≥1 year post-primary cancer treatment completion
- English speaking
- Ambulates without assistance
Show all 10Show fewer
- No antibiotics in past 90 days
- Willing to avoid taking probiotics during the study
- Has access to a safe place to perform aerobic exercise (e.g., willing to walk in neighborhood or has gym membership or owns relevant exercise equipment at home, etc.)
- Has access to good internet and WIFI and device capable of videoconferencing (the study has limited resources to loan tablets and hotspots)
Who cannot join
- Metastatic or recurrent cancer
- Another cancer diagnosis in the past 5 years (not including skin or cervical cancer in situ)
- Unstable angina
- New York Heart Association class II, III, or IV congestive heart failure
- Uncontrolled asthma
- Interstitial lung disease
Show all 22Show fewer
- Current steroid use
- Told by a physician to only do exercise prescribed by a physician
- Dementia or organic brain syndrome
- Schizophrenia or active psychosis
- Connective tissue or rheumatologic disease
- Participating in >30 minutes of exercise on ≥3 days/week in the past six months
- Anticipate elective surgery, medication changes or antibiotics during the study
- Contraindication to ≥moderate intensity aerobic exercise
- Physical limitations that prevent engaging in ≥moderate intensity aerobic exercise
- Breastfeeding, pregnant or anticipate pregnancy during the study
- Plan to move residence during the study
- Plan to travel for more than 1 week during the study
- Anticipate trouble attending the weekly study videoconference calls
- History of bariatric surgery
- Body weight greater than 440 lbs
- Any social, psychological, or physical condition that interferes with the participant's ability to complete study activities or unduly increases study risk
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Understanding the impact exercise has on a cancer survivor's gut microbiome can improve the health and well-being of cancer survivors by enhancing treatments targeting the gut microbiome. Although scientific studies support a link between exercise and the gut microbiome, rigorous randomized trials needed to confirm this causal link are limited and usually involve supervised exercise. Hence, this proposal tests feasibility of a home-based, remote-only research protocol that is more accessible to cancer survivors unable to attend supervised exercise including but not limited to rural populations. This study will also determine if exercise effects on the gut microbiome differ by factors such as race.
Read the detailed description
Forty physically inactive breast cancer survivors will be randomized into 10-week conditions of home-based aerobic exercise training or standard attention control. All participants will be asked to maintain their pre-study diet and attempt to maintain their body weight while participating in the study. Assessments will occur at baseline, week 5 (mid-intervention), and week 10 (post-intervention) by videoconference platform. Study feasibility and changes in the gut microbiome will be assessed.
- Conditions
- Female Breast Cancer
- Being tested
- Home-based exercise intervention
- Keywords
- Exercise, Gut Microbiome, Breast Cancer, Cancer, Aerobic Exercise, Microbiome, Female Breast Cancer, Flexibility Exercise
- Medical subject headings
- Motor Activity, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise interventionBehavioural
A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.
| Study group | Role | What they receive |
|---|---|---|
| Home-based aerobic exercise training | Experimental | home-based aerobic exercise condition will receive a fitness bracelet (with heart rate measurement capability) and weekly exercise counseling from an exercise trainer (i.e., exercise physiologist) by videoconference. The weekly counseling will be guided by the fitness bracelet data (both participant and exercise trainer will share the same log in information). The aerobic exercise progression will gradually increase duration and intensity of aerobic exercise with the goal of improving cardiorespiratory fitness. Receives: Behavioral: Home-based exercise intervention |
| Home-based standard attention flexibility/toning control | Active comparator | Home-based standard attention flexibility/toning control will receive light resistance bands, stretching/toning log book, and weekly videoconference counseling from an exercise trainer. Receives: Behavioral: Home-based exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
Number of participants excluded or not agreeing to participate will be measured
Measured: Baseline
Feasibility - Adherence to study protocol activities
Feasibility measure (e.g. percent of assessments and intervention sessions completed
Measured: Throughout 10 week study period
Feasibility - Attrition rates
Feasibility measure of the number of participants who dropout or are withdrawn
Measured: Throughout 10 week study period
Feasibility - Adverse events
Feasibility measure of the number of adverse events recorded by staff during the study period
Measured: Throughout 10 week study period
Feasibility - Participant satisfaction
Self-Administered survey given to the participant at the conclusion of the 10 week study period
Measured: At conclusion of 10 week study period
Secondary outcomes (33)
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Motion sensor measures physical activity not observed during intervention activities
Measured: Baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Motion sensor measures physical activity not observed during intervention activities
Measured: 5 weeks after baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Motion sensor measures physical activity not observed during intervention activities
Measured: 10 weeks after baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Measured: Baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Measured: 5 weeks after baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Measured: 10 weeks after baseline
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Measured: Baseline
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Measured: 5 weeks after baseline
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Measured: 10 weeks after baseline
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Measured: Baseline
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Measured: 5 weeks after baseline
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Measured: 10 weeks after baseline
Change in physical performance
Participants will complete a 2-minute step test measured by study staff through videoconference
Measured: Baseline
Change in physical performance
Participants will complete a 2-minute step test measured by study staff through videoconference
Measured: 5 weeks after baseline
Change in physical performance
Participants will complete a 2-minute step test measured by study staff through videoconference
Measured: 10 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Measured: Baseline
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Measured: 5 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Measured: 10 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Measured: Baseline
Fatigue measured through fatigue specific questionnaire
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Measured: 5 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Measured: 10 weeks after baseline
Depression and Anxiety measured through specific questionnaire
Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Measured: Baseline
Depression and Anxiety measured through specific questionnaire
Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Measured: 5 weeks after baseline
Depression and Anxiety measured through specific questionnaire
Hospital Anxiety and Depression Scale [HADS] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Measured: 10 weeks after baseline
Sleep dysfunction measured through specific questionnaire
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Measured: Baseline
Sleep dysfunction measured through specific questionnaire
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Measured: 5 weeks after baseline
Sleep dysfunction measured through specific questionnaire
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Measured: 10 weeks after baseline
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Measured: Baseline
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Measured: 5 weeks after baseline
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Measured: 10 weeks after baseline
Post-traumatic stress measured through specific questionnaire
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Measured: Baseline
Post-traumatic stress measured through specific questionnaire
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Measured: 5 weeks after baseline
Post-traumatic stress measured through specific questionnaire
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Measured: 10 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Sep 2021
- Primary completion22 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 breast cancer survivors will be randomized (like flipping a coin) to one of two study conditions: 1) home-based aerobic exercise training (with aerobic exercise progression targeting improved cardiorespiratory fitness) or 2) standard attention control (stretching exercises). All participants will be asked to maintain their usual diet and avoid change in body weight during the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
- Investigators
- Laura Rogers, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000502
- Sponsor's protocol ID
- 300007016
- Other IDs
- BCRFA
- Acronym
- EMBRACE
- Status last verified
- Mar 2024
- First submitted
- 3 Aug 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share participant data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations
- ClinicalTrials.gov ID
- NCT05000502
- Acronym / sponsor ID
- EMBRACE / 300007016
- Conditions
- Female Breast Cancer
- Keywords
- Exercise, Gut Microbiome, Breast Cancer, Cancer, Aerobic Exercise, Microbiome, Female Breast Cancer, Flexibility Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 11 Aug 2021 (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.
Understanding the impact exercise has on a cancer survivor's gut microbiome can improve the health and well-being of cancer survivors by enhancing treatments targeting the gut microbiome. Although scientific studies support a link between exercise and the gut microbiome, rigorous randomized trials needed to confirm this causal link are limited and usually involve supervised exercise. Hence, this proposal tests feasibility of a home-based, remote-only research protocol that is more accessible to cancer survivors unable to attend supervised exercise including but not limited to rural populations. This study will also determine if exercise effects on the gut microbiome differ by factors such as race.
Detailed description
Forty physically inactive breast cancer survivors will be randomized into 10-week conditions of home-based aerobic exercise training or standard attention control. All participants will be asked to maintain their pre-study diet and attempt to maintain their body weight while participating in the study. Assessments will occur at baseline, week 5 (mid-intervention), and week 10 (post-intervention) by videoconference platform. Study feasibility and changes in the gut microbiome will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 40 breast cancer survivors will be randomized (like flipping a coin) to one of two study conditions: 1) home-based aerobic exercise training (with aerobic exercise progression targeting improved cardiorespiratory fitness) or 2) standard attention control (stretching exercises). All participants will be asked to maintain their usual diet and avoid change in body weight during the study.
| Arm | Type | Receives |
|---|---|---|
| Home-based aerobic exercise training | Experimental | Behavioral: Home-based exercise interventionhome-based aerobic exercise condition will receive a fitness bracelet (with heart rate measurement capability) and weekly exercise counseling from an exercise trainer (i.e., exercise physiologist) by videoconference. The weekly counseling will be guided by the fitness bracelet data (both participant and exercise trainer will share the same log in information). The aerobic exercise progression will gradually increase duration and intensity of aerobic exercise with the goal of improving cardiorespiratory fitness. |
| Home-based standard attention flexibility/toning control | Active comparator | Behavioral: Home-based exercise interventionHome-based standard attention flexibility/toning control will receive light resistance bands, stretching/toning log book, and weekly videoconference counseling from an exercise trainer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Non-Hispanic white or black women
- Age 18-70 years
- History of breast cancer stage 0, I, II, or III
- ≥1 year post-primary cancer treatment completion
- English speaking
Key exclusion criteria (22 listed)
- Metastatic or recurrent cancer
- Another cancer diagnosis in the past 5 years (not including skin or cervical cancer in situ)
- Unstable angina
- New York Heart Association class II, III, or IV congestive heart failure
- Uncontrolled asthma
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 |
|---|---|---|
| Home-based exercise interventionA 10-week home-based exercise intervention including weekly video conferences with exercise specialists. | Behavioural | Home-based aerobic exercise training, Home-based standard attention flexibility/toning control |
Primary outcome
Feasibility - Recruitment
Time frame: Baseline
Number of participants excluded or not agreeing to participate will be measured
Feasibility - Adherence to study protocol activities
Time frame: Throughout 10 week study period
Feasibility measure (e.g. percent of assessments and intervention sessions completed
Feasibility - Attrition rates
Time frame: Throughout 10 week study period
Feasibility measure of the number of participants who dropout or are withdrawn
Feasibility - Adverse events
Time frame: Throughout 10 week study period
Feasibility measure of the number of adverse events recorded by staff during the study period
Feasibility - Participant satisfaction
Time frame: At conclusion of 10 week study period
Self-Administered survey given to the participant at the conclusion of the 10 week study period
33 secondary outcomes
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Time frame: Baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Time frame: 5 weeks after baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Time frame: 10 weeks after baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Time frame: Baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Time frame: 5 weeks after baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Time frame: 10 weeks after baseline
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Time frame: Baseline
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Time frame: 5 weeks after baseline
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Time frame: 10 weeks after baseline
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Time frame: Baseline
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Time frame: 5 weeks after baseline
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Time frame: 10 weeks after baseline
Change in physical performance
Time frame: Baseline
Change in physical performance
Time frame: 5 weeks after baseline
Change in physical performance
Time frame: 10 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Time frame: Baseline
Composition of gut microbiota as measured by fecal samples
Time frame: 5 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Time frame: 10 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Time frame: Baseline
Fatigue measured through fatigue specific questionnaire
Time frame: 5 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Time frame: 10 weeks after baseline
Depression and Anxiety measured through specific questionnaire
Time frame: Baseline
Depression and Anxiety measured through specific questionnaire
Time frame: 5 weeks after baseline
Depression and Anxiety measured through specific questionnaire
Time frame: 10 weeks after baseline
Sleep dysfunction measured through specific questionnaire
Time frame: Baseline
Sleep dysfunction measured through specific questionnaire
Time frame: 5 weeks after baseline
Sleep dysfunction measured through specific questionnaire
Time frame: 10 weeks after baseline
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
Time frame: Baseline
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
Time frame: 5 weeks after baseline
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
Time frame: 10 weeks after baseline
Post-traumatic stress measured through specific questionnaire
Time frame: Baseline
Post-traumatic stress measured through specific questionnaire
Time frame: 5 weeks after baseline
Post-traumatic stress measured through specific questionnaire
Time frame: 10 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No. We do not plan to share participant data.
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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.
Laura Rogers, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise intervention in people with Female Breast Cancer, run by University of Alabama at Birmingham 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 10 inclusion and 22 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: finished, as of the sponsor's last update on 22 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility - Recruitment (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2024.