An interventional study of placebo for study drug and (RS)2-(3-benzoylphenyl)-propionic acid in Lymphedema and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Stanford University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-18.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
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.
560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.
This study's enrollment of 14 is below the median of 50 across 403 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: laboratory biomarker analysis
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 · Other: laboratory biomarker analysis
Given PO
Also known as: PLCB
Given PO
Also known as: BPA
Correlative studies
Number of Participants With Incidence of Lymphedema
Participants were evaluated every 3 months up to one year post lymph node dissection
Time frame: Up to 1 year
| Milestone | (RS)2-(3-benzoylphenyl)-Propionic Acid | Placebo for Study Drug |
|---|---|---|
| Started | 7 | 7 |
| Completed | 5 | 4 |
| Not completed | 2 | 3 |
Participants were evaluated every 3 months up to one year post lymph node dissection
| Participants | (RS)2-(3-benzoylphenyl)-Propionic Acid | Placebo for Study Drug |
|---|---|---|
| Number of Participants With Incidence of Lymphedema | 2 | 1 |
Collected over Enrollment to 1 year post axillary lymph node dissection.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| (RS)2-(3-benzoylphenyl)-Propionic Acid | — | 0/7 (0%) | 1/7 (14.3%) |
| Placebo for Study Drug | — | 0/7 (0%) | 1/7 (14.3%) |
| Event | (RS)2-(3-benzoylphenyl)-Propionic Acid | Placebo for Study Drug |
|---|---|---|
| Swollen thumbSkin and subcutaneous tissue disorders | 1/7 | 0/7 |
| Abdominal painGastrointestinal disorders | 0/7 | 1/7 |
| Age, Continuous(years) | (RS)2-(3-benzoylphenyl)-Propionic Acid | Placebo for Study Drug | Total |
|---|---|---|---|
| Mean | 44.8 ± 6.0 | 45.5 ± 10.1 | 45.2 ± 8.3 |
| Sex: Female, Male(Participants) | (RS)2-(3-benzoylphenyl)-Propionic Acid | Placebo for Study Drug | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | (RS)2-(3-benzoylphenyl)-Propionic Acid | Placebo for Study Drug | Total |
|---|---|---|---|
| United States | 7 | 7 | 14 |
Plan to share: Undecided
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This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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