Characterization of Treatment Responses in Lymphedema
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/26/2018 |
| Start Date: | February 28, 2019 |
| End Date: | August 31, 2021 |
| Contact: | Leslie Roche, BSN |
| Email: | lesroche@stanford.edu |
| Phone: | 6507231396 |
This study is designed to investigate the treatment response of lymphedema, of the upper or
lower extremity, during clinical, pharmacologic treatment of lymphedema with oral ketoprofen.
Correlation of clinical responses (changes in limb volume and skin thickness) with changes in
the inflammasome will help to define the molecular substrate of treatment response.
lower extremity, during clinical, pharmacologic treatment of lymphedema with oral ketoprofen.
Correlation of clinical responses (changes in limb volume and skin thickness) with changes in
the inflammasome will help to define the molecular substrate of treatment response.
Patients presenting to the Investigator's Clinic for evaluation and treatment of (upper or
lower extremity) lymphedema, will be assessed for their suitability (of low risk) for medical
treatment with ketoprofen. If there are no contra-indications to taking ketoprofen, after
discussion of FDA warnings, including provision of a written copy of the FDA language to the
patient, and with the recommendation to discuss with the primary physician-of-record,
patients will be provided with a prescription for ketoprofen 200 mg daily (one capsule taken
orally, once daily). Participation in this study will be offered. Two study visits, at
baseline and month 6 are required. Measurements (circumferential and skin thickness) and a
blood sample will be taken at each study visit.
The investigators will try to determine how ketoprofen affects the body tissue by obtaining
blood samples and measurements, before starting treatment and at month 6.
lower extremity) lymphedema, will be assessed for their suitability (of low risk) for medical
treatment with ketoprofen. If there are no contra-indications to taking ketoprofen, after
discussion of FDA warnings, including provision of a written copy of the FDA language to the
patient, and with the recommendation to discuss with the primary physician-of-record,
patients will be provided with a prescription for ketoprofen 200 mg daily (one capsule taken
orally, once daily). Participation in this study will be offered. Two study visits, at
baseline and month 6 are required. Measurements (circumferential and skin thickness) and a
blood sample will be taken at each study visit.
The investigators will try to determine how ketoprofen affects the body tissue by obtaining
blood samples and measurements, before starting treatment and at month 6.
Inclusion Criteria:
- Participants with a history of acquired lymphedema
- Stage 1, 2, or 3
- 18-75 years
- Clinical use of ketoprofen for lymphedema
Exclusion Criteria:
- Active cancer, infection, bleeding tendency, inflammatory disease and/or taking
anti-inflammatory medication will be excluded.
- Pregnant or lactating females
- Inability to take ketoprofen (contra-indicated, e.g patients with known CV, GI, renal,
hepatic disease).
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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