Breast CancerBEATNCT02052115
Behavioral Weight Loss and Exercise After Treatment (BEAT)
A study testing 12 month exercise and weight loss intervention in people with Breast Cancer, run by University of Vermont at 1 site in United States.
Trial summary
Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive)… Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 12 month exercise and weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2016
- 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 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer diagnosis
- Received surgery +/- chemotherapy +/- radiation for treatment of a Stage I, II or III breast cancer. Ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
- Completion of initial therapy 6 weeks prior to study initiation
- BMI of 27-45 kg/m^2
Who cannot join
- Prior diagnosis of malignancy other than non-melanoma skin cancer (i.e. prior non-melanoma skin cancer is not an exclusion criteria)
- Medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
- Inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
- Age <21 and >70
- Presence of body metal
- Psychotic or central nervous system impairment that would limit compliance with study requirements, including dementia
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- Evidence of metastatic disease
- Symptomatic heart disease (chest pain or equivalent with activity)
- Exercise limiting pulmonary disease or need for oxygen to exercise
- Individuals taking mood stabilizing medications including: Lithium, valproic acid, also called divalproex sodium (Depakote), carbamazepine (Tegretol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), ziprasidone (Geodon), clozapine (clorazil)
- Participants with an active neurologic disorder that affects the central nervous system, including seizures, and Parkinson's disease
- Weight loss of >10 lbs in the previous 6 months
- Participation in > 150 minutes of moderate intensity activity by self report, unless activity level by accelerometer is less than 150 minutes of moderate intensity activity
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vermont Cancer Center
Burlington, Vermont, 05405
Kim Dittus, MD, PhD, 802-656-5470, kim.dittus@vtmednet.org
Karen Wilson, MEd, CCRP, 802-656-4101, karen.m.wilson@uvm.edu
About this study
Official title: Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors
Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive) function.
This study will explore the variability in how breast cancer survivors respond to a behavioral weight loss intervention. The primary objectives include determining the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function as measured with task performance at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline only.Additionally, the study is designed to determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months following entry into a behavioral weight loss and exercise intervention.
- Conditions
- Breast Cancer
- Being tested
- 12 month exercise and weight loss intervention
- Keywords
- breast cancer, exercise, weight loss, executive function, breast cancer survivor
- Medical subject headings
- Breast Neoplasms, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 month exercise and weight loss interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise and weight loss | Other | 12 month exercise and weight loss intervention Receives: Behavioral: 12 month exercise and weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of executive function and weight loss success
Determine the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function, measured with task performance and associated brain function imaging (fMRI), at 6 and 12 months.
Measured: 12 months
Secondary outcomes (2)
Correlation of cancer related symptoms and weight loss
Determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months
Measured: 12 months
Efficacy of a weight loss intervention
Determine the effectiveness of a behavioral weight loss and exercise intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Kim Dittus, University of Vermont
- Investigators
- Kim Dittus, MD, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052115
- Sponsor's protocol ID
- VCC 1311
- Other IDs
- 1P20GM103644-01A1
- Acronym
- BEAT
- Status last verified
- Dec 2014
- First submitted
- 30 Jan 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02052115
- Acronym / sponsor ID
- BEAT / VCC 1311
- Conditions
- Breast Cancer
- Keywords
- breast cancer, exercise, weight loss, executive function, breast cancer survivor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Jan 2014 (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.
Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive) function.
This study will explore the variability in how breast cancer survivors respond to a behavioral weight loss intervention. The primary objectives include determining the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function as measured with task performance at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline only.Additionally, the study is designed to determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months following entry into a behavioral weight loss and exercise intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise and weight loss | Other | Behavioral: 12 month exercise and weight loss intervention12 month exercise and weight loss intervention |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer diagnosis
- Received surgery +/- chemotherapy +/- radiation for treatment of a Stage I, II or III breast cancer. Ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
- Completion of initial therapy 6 weeks prior to study initiation
- BMI of 27-45 kg/m^2
Key exclusion criteria (13 listed)
- Prior diagnosis of malignancy other than non-melanoma skin cancer (i.e. prior non-melanoma skin cancer is not an exclusion criteria)
- Medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
- Inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
- Age <21 and >70
- Presence of body metal
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 |
|---|---|---|
| 12 month exercise and weight loss intervention | Behavioural | Exercise and weight loss |
Primary outcome
Correlation of executive function and weight loss success
Time frame: 12 months
Determine the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function, measured with task performance and associated brain function imaging (fMRI), at 6 and 12 months.
2 secondary outcomes
Correlation of cancer related symptoms and weight loss
Time frame: 12 months
Efficacy of a weight loss intervention
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
Kim Dittus, MD, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 month exercise and weight loss intervention in people with Breast Cancer, run by University of Vermont 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 4 inclusion and 13 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 3 Dec 2014. 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?
Contact Kim Dittus, MD, PhD (802-656-5470, kim.dittus@vtmednet.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of executive function and weight loss success (time frame: 12 months). 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 3 Dec 2014.