Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stanford University
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 this disease.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive study drug orally (PO) thrice daily (TID) for up to 1 year in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Axillary lymph node dissection within the preceding 12 months
You may not be if
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
Clareo Health | Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema
