Lymphedema Study for Arm or Leg Lymphedema



Status:Completed
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 90
Updated:9/16/2018
Start Date:March 2009
End Date:March 2017

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Placebo-controlled, Case-controlled, Open Label Therapeutic Trial for Unilateral or Bilateral Lymphedema of Arm or Leg.

This study compares the effectiveness of a study drug versus placebo in the treatment of
lymphedema.

Part 1 is feasibility, exploratory, open-label study of ketoprofen, to document effects.

Part 2, is open-label trial of ketoprofen to document histological response. Part 3 is
double-blind randomized trial of receive placebo or ketoprofen to evaluate safety and
efficacy.

We will try to determine how the study drug affects the body tissue by obtaining tissue
biopsies (small pieces of skin from the arm or leg) before treatment and after treatment.

Inclusion Criteria:

- a history of lymphedema of one or more limbs (unilateral or bilateral), with a
duration of > 6 months.

Exclusion Criteria:

- Patients with active cancer, infection or bleeding tendency will be excluded.

- We will also exclude patients with medical contraindications to NSAIDs, including
history of allergies, know gastrointestinal intolerance, or 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.

- Minors (<18 years of age) *>90 years of age
We found this trial at
1
site
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Stanley G Rockson, MD
Phone: 650-723-1396
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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from
Stanford, CA
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