Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

NCT ID: NCT01893879

Last Updated: 2017-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Lymphedema; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

(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.

Group Type: EXPERIMENTAL

(RS)2-(3-benzoylphenyl)-propionic acid

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

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.

Group Type: PLACEBO_COMPARATOR

placebo for study drug

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

placebo for study drug

Given PO

Intervention Type: DRUG

(RS)2-(3-benzoylphenyl)-propionic acid

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

PLCB; BPA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stanley Rockson

Allan and Tina Neill Professor of Lymphatic Research and Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanley Rockson

Role: PRINCIPAL_INVESTIGATOR

Stanford University Hospitals and Clinics

Locations

Stanford University Hospitals and Clinics

Stanford, California, United States

Countries

United States

Other Identifiers

BRSNSTU0028

Identifier Type: OTHER

Identifier Source: secondary_id

4593

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-20651

Identifier Type: -

Identifier Source: org_study_id