Status:
TERMINATED
Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema
Lead Sponsor:
Stanford University
Conditions:
Lymphedema
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema ...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of study drug in improving chronic lymphedema while further elucidating the role of inflammatory and lymphangiogenic processes in the pathogenesis of t...
Eligibility Criteria
Inclusion
- Axillary lymph node dissection within the preceding 12 months
Exclusion
- Patients with active cancer
- Patients with lymphedema
- Infection or bleeding tendency
- Patients with medical contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including history of allergies, know gastrointestinal intolerance
- Other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate
- Persons not competent to consent
- Patients on aspirin therapy
- Minors (\< 18 years of age)
- Pregnant and/or lactating women
- Males
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01893879
Start Date
April 1 2014
End Date
April 1 2015
Last Update
May 18 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305