Breast CancerF4F tri negNCT01498536
Effect of Diet and Exercise in Breast Cancer Survivors
A study testing aerobic exercise in people with Breast Cancer and Obesity, run by West Virginia University at 1 site in United States.
Trial summary
This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Obesity
- What is being tested?
- aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Aug 2013
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ER/PR/HER2neu negative breast cancer
- at least 3 months after end of treatment
- BMI at least 25
Who cannot join
- stage IV cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Fit for the Fight: Effect of a Multidisciplinary Diet and Exercise Program on Body Weight, Quality of Life and Inflammation in Survivors of Triple-negative Breast Cancer
This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.
- Conditions
- Breast Cancer, Obesity
- Being tested
- aerobic exercise
- Medical subject headings
- Breast Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
3 times per week for 12-weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
aim for loss of 10% of BMI
Measured: 12 weeks
quality of life
Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires
Measured: 12 weeks
Secondary outcomes (1)
markers of inflammation
blood draws at beginning and end of study to analyze any effect on inflammation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Swisher, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498536
- Sponsor's protocol ID
- H-22426
- Acronym
- F4F tri neg
- Status last verified
- Oct 2013
- First submitted
- 20 Dec 2011
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit for the Fight: Effect of a Multidisciplinary Diet and Exercise Program on Body Weight, Quality of Life and Inflammation in Survivors of Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01498536
- Acronym / sponsor ID
- F4F tri neg / H-22426
- Conditions
- Breast Cancer, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Dec 2011 (estimated)
- 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 seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ER/PR/HER2neu negative breast cancer
- at least 3 months after end of treatment
- BMI at least 25
Key exclusion criteria (1 listed)
- stage IV cancer
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 |
|---|---|---|
| aerobic exercise3 times per week for 12-weeks | Behavioural | – |
Primary outcome
weight loss
Time frame: 12 weeks
aim for loss of 10% of BMI
quality of life
Time frame: 12 weeks
Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires
1 secondary outcome
markers of inflammation
Time frame: 12 weeks
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 30 Oct 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise in people with Breast Cancer and Obesity, run by West Virginia University 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 3 inclusion and 1 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 30 Oct 2013. 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?
weight loss (time frame: 12 weeks). The study lists 2 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 30 Oct 2013.