LymphedemaNCT00383604
Breast Cancer Lymphedema: Role of Insulin Resistance/FOXC2
An observational study of Lymphedema and Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
To better understand the mechanisms leading to lymphedema development in breast cancer survivors, and the implications for potential innovative approaches to the screening, prevention and treatment of this condition. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Breast Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Apr 2012
- Phase
- Observational
- 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
Study population: Breast cancer survivors
Who may be able to join
- Patients enrolled in the proposed studies must be survivors of breast cancer at a time point at least 4 years following the initial surgery and radiotherapy for the disease.
- Patients must have a history of unilateral axillary lymph node dissection.
- Patients referred to, or that receive their care within the Stanford University Breast Cancer Program and the Stanford Center for Lymphatic and Venous Disorders.
- Patients will be required to have the capacity to provide informed consent.
Who cannot join
- Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
- Patients will not be enrolled if they are taking drugs that affect carbohydrate metabolism.
- Patients with recurrent breast cancer or other forms of pre-existing lymphedema will be ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To better understand the mechanisms leading to lymphedema development in breast cancer survivors, and the implications for potential innovative approaches to the screening, prevention and treatment of this condition.
Read the detailed description
Lymphedema of the arm is an important, under-recognized, and under-treated complication of successful surgical and radiotherapeutic treatment of breast cancer. As a result of advances in early detection and effective adjuvant therapies, many women diagnosed with breast cancer today can expect survival that is similar to age-matched women without breast cancer. Nevertheless, this source of substantial physical and psychological morbidity has not attracted sufficient attention from industry or the scientific research community to result in either effective risk stratification or the availability highly effective therapeutic interventions.
While the presence and degree of arm edema can, in part, correlated with the extent of axillary surgery, we still comprehend only poorly the factors that predispose to overt lymphatic insufficiency in the patients at risk for lymphedema by virtue of prior breast cancer treatment. It is likely that this anatomic and regenerative variability relies, at least in part, upon an as yet undefined genetic substrate. A growing body of evidence suggests that mutations in the nuclear transcription gene FOXC2 are responsible for a broad clinical array of primary lymphedema syndromes. The biology of breast cancer-associated lymphedema, including its characteristic latency phase, suggests that similar mechanisms may operate in the predisposition to this and other forms of secondary lymphedema.
In parallel, breast cancer-associated lymphedema has several clinical attributes that suggest a relationship to, and a role for, insulin resistance. In this regard, it is interesting to contemplate the recent, multiple lines of evidence that suggest that the gene FOXC2 regulates, directly or indirectly, several aspects of adipocyte metabolism and that genetic variability in the gene may influence features associated with the insulin resistance and the metabolic syndrome. These observations are of particular interest because of the recognized relationship of FOXC2 haploinsufficiency to a variety of identified lymphedema syndromes. It is therefore attractive to conjecture that insulin resistance, perhaps mediated through polymorphisms of FOXC2,.confers secondary lymphedema risk and predisposes to the as yet poorly understood tendency for breast cancer survivors to acquire substantial, pathological deposits of adipose tissue in the affected extremities with chronicity of the lymphedema.
The specific aims of this proposal are as follows: (1) to quantitatively assess insulin sensitivity in late breast cancer survivors, equally divided among subjects who display clinical evidence of ipsilateral arm edema and those that do not; (2) to correlate the presence of relative insulin resistance to the expression of breast cancer-associated lymphedema. It is hypothesized that such an approach has the capability to lead to future elaboration of appropriate risk stratification and targeted therapeutic interventions; (3) as a pilot investigation, to sequence the FOXC2 gene, including the untranslated 5' region, in each these patients, to identify potential polymorphisms that might correlate both to the presence of insulin resistance and lymphedema risk.
- Conditions
- Lymphedema, Breast Cancer
- Medical subject headings
- Lymphedema, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
assess insulin sensitivity in late breast cancer survivors
Measured: visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startJul 2005
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Responsible party
- Sponsor
- Investigators
- Stanley G Rockson, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383604
- Sponsor's protocol ID
- BRSNSTU0009
- Other IDs
- 96204, BRSNSTU0009, 2580
- Status last verified
- May 2013
- First submitted
- 29 Sep 2006
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Lymphedema: Role of Insulin Resistance/FOXC2
- ClinicalTrials.gov ID
- NCT00383604
- Acronym / sponsor ID
- BRSNSTU0009
- Conditions
- Lymphedema, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Study start
- Jul 2005
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Oct 2006 (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.
To better understand the mechanisms leading to lymphedema development in breast cancer survivors, and the implications for potential innovative approaches to the screening, prevention and treatment of this condition.
Detailed description
Lymphedema of the arm is an important, under-recognized, and under-treated complication of successful surgical and radiotherapeutic treatment of breast cancer. As a result of advances in early detection and effective adjuvant therapies, many women diagnosed with breast cancer today can expect survival that is similar to age-matched women without breast cancer. Nevertheless, this source of substantial physical and psychological morbidity has not attracted sufficient attention from industry or the scientific research community to result in either effective risk stratification or the availability highly effective therapeutic interventions.
While the presence and degree of arm edema can, in part, correlated with the extent of axillary surgery, we still comprehend only poorly the factors that predispose to overt lymphatic insufficiency in the patients at risk for lymphedema by virtue of prior breast cancer treatment. It is likely that this anatomic and regenerative variability relies, at least in part, upon an as yet undefined genetic substrate. A growing body of evidence suggests that mutations in the nuclear transcription gene FOXC2 are responsible for a broad clinical array of primary lymphedema syndromes. The biology of breast cancer-associated lymphedema, including its characteristic latency phase, suggests that similar mechanisms may operate in the predisposition to this and other forms of secondary lymphedema.
In parallel, breast cancer-associated lymphedema has several clinical attributes that suggest a relationship to, and a role for, insulin resistance. In this regard, it is interesting to contemplate the recent, multiple lines of evidence that suggest that the gene FOXC2 regulates, directly or indirectly, several aspects of adipocyte metabolism and that genetic variability in the gene may influence features associated with the insulin resistance and the metabolic syndrome. These observations are of particular interest because of the recognized relationship of FOXC2 haploinsufficiency to a variety of identified lymphedema syndromes. It is therefore attractive to conjecture that insulin resistance, perhaps mediated through polymorphisms of FOXC2,.confers secondary lymphedema risk and predisposes to the as yet poorly understood tendency for breast cancer survivors to acquire substantial, pathological deposits of adipose tissue in the affected extremities with chronicity of the lymphedema.
The specific aims of this proposal are as follows: (1) to quantitatively assess insulin sensitivity in late breast cancer survivors, equally divided among subjects who display clinical evidence of ipsilateral arm edema and those that do not; (2) to correlate the presence of relative insulin resistance to the expression of breast cancer-associated lymphedema. It is hypothesized that such an approach has the capability to lead to future elaboration of appropriate risk stratification and targeted therapeutic interventions; (3) as a pilot investigation, to sequence the FOXC2 gene, including the untranslated 5' region, in each these patients, to identify potential polymorphisms that might correlate both to the presence of insulin resistance and lymphedema risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer survivors
Key inclusion criteria (4 listed)
- Patients enrolled in the proposed studies must be survivors of breast cancer at a time point at least 4 years following the initial surgery and radiotherapy for the disease.
- Patients must have a history of unilateral axillary lymph node dissection.
- Patients referred to, or that receive their care within the Stanford University Breast Cancer Program and the Stanford Center for Lymphatic and Venous Disorders.
- Patients will be required to have the capacity to provide informed consent.
Key exclusion criteria (3 listed)
- Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
- Patients will not be enrolled if they are taking drugs that affect carbohydrate metabolism.
- Patients with recurrent breast cancer or other forms of pre-existing lymphedema will be ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assess insulin sensitivity in late breast cancer survivors
Time frame: visit 2
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 May 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.
Stanley G Rockson principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema and Breast Cancer, run by Stanford 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 4 inclusion and 3 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 May 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?
assess insulin sensitivity in late breast cancer survivors (time frame: visit 2). 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 May 2013.