Clinical trial · Interventional
Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors
NCT00064857CI-TRIAL-00001420completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to evaluate the effectiveness of a standardized botanical extract of Pycnogenol as a treatment for stable arm lymphedema in breast cancer survivors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pycnogenol | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Unilateral (ipsilateral to breast cancer resection side) lymphedema of the upper extremity. * Extravascular water ration of \> 1.07/1 between affected vs. normal arm using multiple frequency bioelectric impedence * Patient is \> 2months from last surgical or radiation treatment to the affected axilla * Renal and hepatic function: Creatinine clearance \> 50ml/min, total bili \<2 mg/dl, transaminases \<1.5 x ULN * Patient not pregnant or breastfeeding. Use of barrier contraception if sexually active. * ECOG performance of 0-2 * Patient not allergic to pycnogenol Exclusion criteria: * Patients treated with their first course of chemotherapy or radiation * Chemotherapy or radiation to axillary lymph node will exclude patients for 8 weeks following treatment * Patients with more than one episode of arm cellulitis, venous clot, or woody fibrosis of the affected arm. Antibiotics used to treat cellulitis must be completed at least 4 weeks prior to initial screening * Patients with a defibrillator Midazolam study only: Patients requiring or benefiting from supplemental oxygen, patients allergic to cherries
References
Publications (0)
Data not yet available
No reference posted for this study.