Back to resultsPlacebo-Controlled Therapeutic Trial for the Prevention of Lymphedema (PCTTPL)
Primary Purpose
Lymphedema, Unspecified Adult Solid Tumor, Protocol Specific
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
placebo for study drug
(RS)2-(3-benzoylphenyl)-propionic acid
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional prevention trial for Lymphedema
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
Sites / Locations
- Stanford University Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
(RS)2-(3-benzoylphenyl)-propionic acid
placebo for study drug
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants With Incidence of Lymphedema
Participants were evaluated every 3 months up to one year post lymph node dissection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01893879
Brief Title
Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema
Acronym
PCTTPL
Official Title
Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
insufficient enrollment
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Unspecified Adult Solid Tumor, Protocol Specific
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(RS)2-(3-benzoylphenyl)-propionic acid
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo for study drug
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo for study drug
Other Intervention Name(s)
PLCB
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
(RS)2-(3-benzoylphenyl)-propionic acid
Other Intervention Name(s)
BPA
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Number of Participants With Incidence of Lymphedema
Description
Participants were evaluated every 3 months up to one year post lymph node dissection
Time Frame
Up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Rockson
Organizational Affiliation
Stanford University Hospitals and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Hospitals and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema
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