Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

NCT01893879 | Terminated Results DMC

• 3 other identifiers: IRB-20651BRSNSTU00284593
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Incidence of Lymphedema

  Participants were evaluated every 3 months up to one year post lymph node dissection

  Up to 1 year

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: (RS)2-(3-benzoylphenyl)-propionic acid; Other: laboratory biomarker analysis

placebo for study drug

PLACEBO COMPARATOR

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.

Drug: placebo for study drug; Other: laboratory biomarker analysis

Interventions

placebo for study drug DRUG

Given PO

Also known as: PLCB

placebo for study drug

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

Given PO

Also known as: BPA

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

laboratory biomarker analysis OTHER

Correlative studies

(RS)2-(3-benzoylphenyl)-propionic acid; placebo for study drug

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Axillary lymph node dissection within the preceding 12 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Results Point of Contact

• Title: Leslie Roche, RN
• Organization: Stanford University

lesroche@stanford.edu

650-723-1396

Study Officials

• Stanley Rockson

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Allan and Tina Neill Professor of Lymphatic Research and Medicine

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 9, 2013
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 18, 2017
• Results First Posted: May 18, 2017

Record last verified: 2017-04

Locations

US (1)