Trial Outcomes & Findings for Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema (NCT NCT01893879)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2017-05-18

Participant milestones
Measure	(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. (RS)2-(3-benzoylphenyl)-propionic acid: Given PO laboratory biomarker analysis: Correlative studies	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. placebo for study drug: Given PO laboratory biomarker analysis: Correlative studies
Overall Study STARTED	7	7
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	2	3

Withdrawal data not reported

Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

Baseline characteristics by cohort
Measure	(RS)2-(3-benzoylphenyl)-Propionic Acid n=7 Participants 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	Placebo for Study Drug n=7 Participants 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 n=14 Participants Total of all reporting groups
Age, Continuous	44.8 years STANDARD_DEVIATION 6.0 • n=5 Participants	45.5 years STANDARD_DEVIATION 10.1 • n=7 Participants	45.2 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

Timeframe: Up to 1 year

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

Outcome measures
Measure	(RS)2-(3-benzoylphenyl)-Propionic Acid n=5 Participants 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	Placebo for Study Drug n=4 Participants 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
Number of Participants With Incidence of Lymphedema	2 Participants	1 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	(RS)2-(3-benzoylphenyl)-Propionic Acid n=7 participants at risk 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	Placebo for Study Drug n=7 participants at risk 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
Skin and subcutaneous tissue disorders Swollen thumb	14.3% 1/7 • Number of events 1 • Enrollment to 1 year post axillary lymph node dissection.	0.00% 0/7 • Enrollment to 1 year post axillary lymph node dissection.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Enrollment to 1 year post axillary lymph node dissection.	14.3% 1/7 • Number of events 1 • Enrollment to 1 year post axillary lymph node dissection.

Stanford University

Phone: 650-723-1396