Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

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.

Inclusion Criteria:

- Axillary lymph node dissection within the preceding 12 months

Exclusion Criteria:

- 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