Clinical trial · Interventional
Pycnogenol for the Treatment of Lymphedema
Treatment of Arm Lymphedema in Breast Cancer Survivors: A Double-Blind, Randomized Study of Pycnogenol vs. Placebo
NCT00214032CI-TRIAL-00019332completedPhase 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 objectives of this study are to evaluate the effectiveness of Pycnogenol (French maritime pine bark extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedence as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Pycnogenol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- pycnogenol daily
- interventionNames
- Drug: Pycnogenol
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- placebo daily
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- reduction of arm lymphedema
- timeFrame
- monthly
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 6 months from last surgical and/or radiation treatment to the affected axilla * Unilateral lymphedema of the upper extremity Exclusion Criteria: * May not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this study
References
Publications (0)
Data not yet available
No reference posted for this study.