Clinical trial · Interventional
Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema
Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients
NCT01893879CI-TRIAL-00027670PCTTPLterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient enrollment
Summary
Brief summary (as posted)
This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection.
Conditions
Conditions (2)
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 | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| placebo for study drug | Drug | — | UNRESOLVED |
| (RS)2-(3-benzoylphenyl)-propionic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- (RS)2-(3-benzoylphenyl)-propionic acid
- description
- Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity. Laboratory biomarker analysis will be performed.
- interventionNames
- Drug: (RS)2-(3-benzoylphenyl)-propionic acid
- Other: laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- placebo for study drug
- description
- Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity. Laboratory biomarker analysis will be performed.
- interventionNames
- Drug: placebo for study drug
- Other: laboratory biomarker analysis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.