Stanley G. Rockson, MD
Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
To compare the effectiveness of usual treatments for lymphedema (massage and elastic sleeve), instituted even before the development of swelling, compared to the use of a newly marketed device, the Flexitouch?, which electronically simulates the effect of massage upon lymph flow.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: Flexitouch
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Patients referred to the surgeons of
the Stanford University Breast Cancer
Program
2. Patients will be required to have the
capacity to provide informed consent.
3. All experimental protocols will be
reviewed and approved by the
Stanford Institutional Review Board
for the Protection of Human
Subjects.
4. All of the subjects to be enrolled in
the proposed studies will be patients
with unilateral breast cancer who are
scheduled to undergo breast surgery
and axillary lymph node dissection,
with or without breast conserving
techniques.
Key Exclusion Criteria:
1. 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.
2. Patients with recurrent breast cancer
or other forms of pre-existing
lymphedema will be ineligible.
Additional Study Details
Official Title:
To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk StatusAnticipated start date:
5/10/2005Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
Single BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- To prospectively assess the presence of newly developing lymphedema in each study subgroup through serial assessment of segmental interstitial fluid content by multiple frequency bioimpedance
Secondary Outcomes:
- To evaluate the preventive interventions in a prospective, randomized fashion, contrasting the responses of equivalent numbers of patients randomized to 2 experimental arms and the control arm of the study
- To correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume
Total Number to be Enrolled:
200Total Number to be Enrolled at Stanford:
200More Information
Secondary ID(s):
- 95970
- BRSNSTU0007
- NCT00383500
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/23/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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