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Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema (PCTTPL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893879
Recruitment Status : Terminated (insufficient enrollment)
First Posted : July 9, 2013
Results First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphedema Unspecified Adult Solid Tumor, Protocol Specific Drug: placebo for study drug Drug: (RS)2-(3-benzoylphenyl)-propionic acid Other: laboratory biomarker analysis Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients
Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arms and Interventions
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Arm Intervention/treatment
Experimental: (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.

 Drug: (RS)2-(3-benzoylphenyl)-propionic acid
Given PO
Other Name: BPA

Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: 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.

 Drug: placebo for study drug
Given PO
Other Name: PLCB

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Incidence of Lymphedema [ Time Frame: Up to 1 year ]
    Participants were evaluated every 3 months up to one year post lymph node dissection


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893879


Locations
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United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Stanley Rockson Stanford University Hospitals and Clinics
More Information
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Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01893879    
Other Study ID Numbers: IRB-20651
BRSNSTU0028 ( Other Identifier: OnCore )
4593 ( Other Identifier: Stanford University Hospitals and Clinics )
First Posted: July 9, 2013    Key Record Dates
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action