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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

Medical subject headings
Lymphedema, Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted3 Oct 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionMar 2012
  4. Study completionApr 2012

Resources

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)
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

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.

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