Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

— PCTTPL  

Official title:

Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01893879
• Other study ID #: BRSNSTU0028
• Status: Terminated
• Phase: N/A
• First received: July 2, 2013
• Last updated: October 13, 2016
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lymphedema
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• placebo for study drug
Given PO
• (RS)2-(3-benzoylphenyl)-propionic acid
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Stanford University Hospitals and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of lymphedema and/or severity of lymphedema		Up to 5 years	No