Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

Not Applicable

Terminated

• Conditions: Lymphedema; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: (RS)2-(3-benzoylphenyl)-propionic acid; Drug: placebo for study drug; Other: laboratory biomarker analysis

• Registration Number: NCT01893879
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of study drug in improving chronic lymphedema while further elucidating the role of inflammatory and lymphangiogenic processes in the pathogenesis of this disease.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive study drug orally (PO) thrice daily (TID) for up to 1 year in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Study Timeline

• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Study Start: 2014-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-12-09
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-13
• Last Update Submitted: 2017-04-13
• Results First Posted: 2017-05-18
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

• Axillary lymph node dissection within the preceding 12 months

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(RS)2-(3-benzoylphenyl)-propionic acid	(RS)2-(3-benzoylphenyl)-propionic acid	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.
(RS)2-(3-benzoylphenyl)-propionic acid	laboratory biomarker analysis	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.
placebo for study drug	placebo for study drug	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.
placebo for study drug	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Incidence of Lymphedema	Up to 1 year	Participants were evaluated every 3 months up to one year post lymph node dissection

Trial Locations

Locations (1)

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States