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

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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Lymphedema
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: placebo for study drug
Drug: (RS)2-(3-benzoylphenyl)-propionic acid
Other: laboratory biomarker analysis
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title (RS)2-(3-benzoylphenyl)-Propionic Acid Placebo for Study Drug
Hide Arm/Group 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.

(RS)2-(3-benzoylphenyl)-propionic acid: Given PO

laboratory biomarker analysis: Correlative studies

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.

placebo for study drug: Given PO

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 7 7
Completed 5 4
Not Completed 2 3
Arm/Group Title (RS)2-(3-benzoylphenyl)-Propionic Acid Placebo for Study Drug Total
Hide Arm/Group Description

Patients receive study drug three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.

Laboratory biomarker analysis will be performed.

(RS)2-(3-benzoylphenyl)-propionic acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.

Laboratory biomarker analysis will be performed.

placebo for study drug: Given PO

laboratory biomarker analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
44.8  (6.0) 45.5  (10.1) 45.2  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
7
 100.0%
7
 100.0%
14
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Number of Participants With Incidence of Lymphedema
Hide Description Participants were evaluated every 3 months up to one year post lymph node dissection
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title (RS)2-(3-benzoylphenyl)-Propionic Acid Placebo for Study Drug
Hide Arm/Group 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.

(RS)2-(3-benzoylphenyl)-propionic acid: Given PO

laboratory biomarker analysis: Correlative studies

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.

placebo for study drug: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
1
  25.0%
Time Frame Enrollment to 1 year post axillary lymph node dissection.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title (RS)2-(3-benzoylphenyl)-Propionic Acid Placebo for Study Drug
Hide Arm/Group 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.

(RS)2-(3-benzoylphenyl)-propionic acid: Given PO

laboratory biomarker analysis: Correlative studies

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.

placebo for study drug: Given PO

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
(RS)2-(3-benzoylphenyl)-Propionic Acid Placebo for Study Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
(RS)2-(3-benzoylphenyl)-Propionic Acid Placebo for Study Drug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
(RS)2-(3-benzoylphenyl)-Propionic Acid Placebo for Study Drug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      1/7 (14.29%)    
Gastrointestinal disorders     
Abdominal pain  [1]  0/7 (0.00%)  0 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders     
Swollen thumb   1/7 (14.29%)  1 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
2 days of mild abdominal pain, resolved spontaneously
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Leslie Roche, RN
Organization: Stanford University
Phone: 650-723-1396
Responsible Party: Stanley Rockson, Stanford University
ClinicalTrials.gov Identifier: NCT01893879     History of Changes
Other Study ID Numbers: IRB-20651
BRSNSTU0028 ( Other Identifier: OnCore )
4593 ( Other Identifier: Stanford University Hospitals and Clinics )
First Submitted: July 2, 2013
First Posted: July 9, 2013
Results First Submitted: December 9, 2016
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017