Breast CancerNCT00120029
Peer Counseling for Weight Loss
A study testing weight loss counseling in people with Breast Cancer, run by Wayne State University at 1 site in United States.
Trial summary
The efficacy of peer counseling for weight loss maintenance is being tested in obese and overweight African American breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 71 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- weight loss counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jun 2008
- 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 71 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obese
- African American
- Up to 7 years post breast cancer diagnosis
- Able to keep food records
- Have a telephone
- Stable weight within 5 pounds last 2 months
Who cannot join
- Breast cancer recurrence
- History of other cancers
- Uncontrolled congestive heart failure
- Untreated hypertension
- Disabling osteoarthritis
- Abusing drugs or alcohol
- Have psychiatric conditions that interfere with counseling
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wayne State University
Detroit, Michigan, 48201
Donna Ford, 313-745-5774, dford@med.wayne.edu
Zora Djuric, PhD
About this study
Official title: Peer Counseling for Weight Loss in African American Breast Cancer Survivors
The efficacy of peer counseling for weight loss maintenance is being tested in obese and overweight African American breast cancer survivors.
Read the detailed description
Obesity has adverse effects on breast cancer survival and recurrence, and this may be mediated via the insulin resistance that is associated with obesity. This is a matter of exceptional concern for African-American (AA) breast cancer survivors since a greater proportion of AAs than European Americans (EA) are obese, insulin-resistant and diabetic. This proposal seeks to test the effects of weight loss intervention in obese and overweight AA breast cancer survivors (body mass index 25-40 kg/m2, stage I, II, or IIIA cancer, free of recurrence). Subjects (n=100) will be randomized across 3 arms: 1) control; 2) individualized, dietitian-led counseling; and 3) dietitian-led counseling combined with peer counseling using telephone counseling by trained peers who are AA breast cancer survivors successful at weight control. Psychosocial factors that can affect the extent of weight loss achieved will be assessed, including individual, home and community-level factors. Some of these factors may change when weight loss is achieved and will be assessed both before and after intervention. Genetic polymorphisms that have been shown to be associated with increased body weight, insulin resistance, lipid metabolism, and oxidative stress will be determined and related to both baseline and post-intervention anthropometric and biologic measures. This should further help elucidate inter-individual differences in response to weight loss intervention. The possible beneficial effects of weight loss on the health risks associated with obesity will be evaluated with measures of insulin resistance, insulin-like growth factor and lipid levels in blood samples, as well as with blood pressure and anthropometric measures. The effects of weight loss on these measures have been studied in other obese and overweight populations, but there is little data in breast cancer survivors. Finally, we will attempt to determine if beneficial effects of weight loss can be detected in the breast, since this should be related to subsequent breast cancer risk. The breast contralateral to surgery will be subjected to ductal lavage at baseline, 12 and 24 months. The investigators will examine the effects of weight change on markers of oxidative stress in the breast nipple aspirate fluid that is obtained as part of the lavage procedure. Levels of lipid peroxidation are very high in this fluid and have been related to both nuclear atypia and breast cancer risk. The nuclear morphology of epithelial cells obtained by ductal lavage therefore will be quantified as well. Weight loss in obese and overweight AA breast cancer survivors should improve both psychosocial function and biological indicators of health risks.
- Conditions
- Breast Cancer
- Being tested
- weight loss counseling
- Keywords
- weight loss, survivorship, breast ductal lavage, exercise, diet
- Medical subject headings
- Breast Neoplasms, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight loss counselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Secondary outcomes (4)
markers of oxidative stress in blood and breast fluid
markers of cardiovascular health in blood
body fat
fitness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startJan 2004
- Study completionJun 2008 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Barbara Ann Karmanos Cancer Institute, University of Michigan
- Investigators
- Zora Djuric, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120029
- Sponsor's protocol ID
- 057103MP4F
- Other IDs
- 1P50ES012395
- Status last verified
- Jun 2008
- First submitted
- 6 Jul 2005
- Last updated
- 5 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Counseling for Weight Loss in African American Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00120029
- Acronym / sponsor ID
- 057103MP4F
- Conditions
- Breast Cancer
- Keywords
- weight loss, survivorship, breast ductal lavage, exercise, diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Barbara Ann Karmanos Cancer Institute, University of Michigan
- Study start
- Jan 2004
- Study completion
- Jun 2008 (estimated)
- First posted
- 14 Jul 2005 (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 efficacy of peer counseling for weight loss maintenance is being tested in obese and overweight African American breast cancer survivors.
Detailed description
Obesity has adverse effects on breast cancer survival and recurrence, and this may be mediated via the insulin resistance that is associated with obesity. This is a matter of exceptional concern for African-American (AA) breast cancer survivors since a greater proportion of AAs than European Americans (EA) are obese, insulin-resistant and diabetic. This proposal seeks to test the effects of weight loss intervention in obese and overweight AA breast cancer survivors (body mass index 25-40 kg/m2, stage I, II, or IIIA cancer, free of recurrence). Subjects (n=100) will be randomized across 3 arms: 1) control; 2) individualized, dietitian-led counseling; and 3) dietitian-led counseling combined with peer counseling using telephone counseling by trained peers who are AA breast cancer survivors successful at weight control. Psychosocial factors that can affect the extent of weight loss achieved will be assessed, including individual, home and community-level factors. Some of these factors may change when weight loss is achieved and will be assessed both before and after intervention. Genetic polymorphisms that have been shown to be associated with increased body weight, insulin resistance, lipid metabolism, and oxidative stress will be determined and related to both baseline and post-intervention anthropometric and biologic measures. This should further help elucidate inter-individual differences in response to weight loss intervention. The possible beneficial effects of weight loss on the health risks associated with obesity will be evaluated with measures of insulin resistance, insulin-like growth factor and lipid levels in blood samples, as well as with blood pressure and anthropometric measures. The effects of weight loss on these measures have been studied in other obese and overweight populations, but there is little data in breast cancer survivors. Finally, we will attempt to determine if beneficial effects of weight loss can be detected in the breast, since this should be related to subsequent breast cancer risk. The breast contralateral to surgery will be subjected to ductal lavage at baseline, 12 and 24 months. The investigators will examine the effects of weight change on markers of oxidative stress in the breast nipple aspirate fluid that is obtained as part of the lavage procedure. Levels of lipid peroxidation are very high in this fluid and have been related to both nuclear atypia and breast cancer risk. The nuclear morphology of epithelial cells obtained by ductal lavage therefore will be quantified as well. Weight loss in obese and overweight AA breast cancer survivors should improve both psychosocial function and biological indicators of health risks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 71 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Overweight or obese
- African American
- Up to 7 years post breast cancer diagnosis
- Able to keep food records
- Have a telephone
Key exclusion criteria (7 listed)
- Breast cancer recurrence
- History of other cancers
- Uncontrolled congestive heart failure
- Untreated hypertension
- Disabling osteoarthritis
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 |
|---|---|---|
| weight loss counseling | Behavioural | – |
Primary outcome
weight loss
4 secondary outcomes
markers of oxidative stress in blood and breast fluid
markers of cardiovascular health in blood
body fat
fitness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2008.
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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.
Zora Djuric, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight loss counseling in people with Breast Cancer, run by Wayne State 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 6 inclusion and 7 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 5 Sep 2008. 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 Donna Ford, BS (313-745-5774, dford@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss. 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 5 Sep 2008.