Breast CancerNCT01582685
Exercise in Breast Cancer Survivors
A study testing Exercise in people with Breast Cancer and Obesity, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Obesity
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age and < 65 years of age
- Female
- BMI > 25
- Weight < 350 pounds
- English as a primary language
- Postmenopausal
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- Invasive ER-positive cancer on biopsy and subsequent definitive surgical therapy
- Received and Completed standard of care adjuvant therapy (Concurrent endocrine therapy acceptable)
- 6-12 months after completion of therapy (excluding adjuvant endocrine therapy) at time of randomization
Who cannot join
- Recurrent breast cancer
- DCIS only (no invasive component)
- Taking a Beta Blocker or Verapamil
- Pregnant
- Wheelchair bound
- Unable to ambulate independently
Show all 11Show fewer
- Concurrent uncontrolled medical or psychiatric disorder
- Open wound
- Stage IV breast cancer
- Progression of disease
- Bilateral mastectomies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Health Care
Jackson, Mississippi, 39216
About this study
Official title: Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile
The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Exercise is expected to result in a circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer tumor, growth of microscopic residual disease after breast cancer resection, decreases rates of local-regional recurrence, decreases rates of distant recurrence, and increases survival.
- Conditions
- Breast Cancer, Obesity
- Being tested
- Exercise
- Keywords
- Breast Cancer, Obesity, Exercise, Angiogenesis
- Medical subject headings
- Breast Neoplasms, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | The intervention is a structured walking program which will be performed partly in the Pavilion Physical Therapy clinic and partly at home. The participant will be instructed in how hard to exercise, how long to exercise, and how many times in a week to exercise. You will also be instructed in how to exercise safely. Receives: Behavioral: Exercise |
| No Exercise | No intervention | These participants will receive standard of care follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors.
Number of participants that enroll in the study and actually complete the study
Measured: 12 months
Secondary outcomes (2)
IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype:
IFG-1 levels,unbound VEGF levels, Endostatin levels
Measured: 12 months
Amount of adipose tissue mass as measured on CT scans in obese breast cancer survivors before and after exercise intervention as a measure of weight loss
Adipose tissue mass volume as measured on CT scan
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 posted23 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: no patients enrolled
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natale Sheehan, University of Mississippi Medical Center
- Investigators
- Natale Sheehan, MD, Principal investigator, University of Mississippi Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582685
- Sponsor's protocol ID
- 2011-0121
- Status last verified
- Dec 2014
- First submitted
- 2 Apr 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile
- ClinicalTrials.gov ID
- NCT01582685
- Acronym / sponsor ID
- 2011-0121
- Conditions
- Breast Cancer, Obesity
- Keywords
- Breast Cancer, Obesity, Exercise, Angiogenesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Apr 2012 (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.
The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Exercise is expected to result in a circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer tumor, growth of microscopic residual disease after breast cancer resection, decreases rates of local-regional recurrence, decreases rates of distant recurrence, and increases survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: ExerciseThe intervention is a structured walking program which will be performed partly in the Pavilion Physical Therapy clinic and partly at home. The participant will be instructed in how hard to exercise, how long to exercise, and how many times in a week to exercise. You will also be instructed in how to exercise safely. |
| No Exercise | No intervention | –These participants will receive standard of care follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- > 18 years of age and < 65 years of age
- Female
- BMI > 25
- Weight < 350 pounds
- English as a primary language
Key exclusion criteria (11 listed)
- Recurrent breast cancer
- DCIS only (no invasive component)
- Taking a Beta Blocker or Verapamil
- Pregnant
- Wheelchair bound
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 |
|---|---|---|
| ExerciseThe participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks. | Behavioural | Exercise Group |
Primary outcome
Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors.
Time frame: 12 months
Number of participants that enroll in the study and actually complete the study
2 secondary outcomes
IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype:
Time frame: 12 months
Amount of adipose tissue mass as measured on CT scans in obese breast cancer survivors before and after exercise intervention as a measure of weight loss
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 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.
Natale Sheehan, MD principal investigator
University of Mississippi Health Care
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 in people with Breast Cancer and Obesity, run by University of Mississippi Medical Center 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 9 inclusion and 11 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: withdrawn, as of the sponsor's last update on 2 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors. (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 2 Dec 2014.