Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BRSNSTU0028 | Other Identifier | OnCore | |
| 4593 | Other Identifier | Stanford University Hospitals and Clinics |
Not provided
Not provided
insufficient enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (RS)2-(3-benzoylphenyl)-propionic acid | Experimental | 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. |
|
| placebo for study drug | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo for study drug | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incidence of Lymphedema | Participants were evaluated every 3 months up to one year post lymph node dissection | Up to 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stanley Rockson | Stanford University Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hospitals and Clinics | Stanford | California | 94305 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | (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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | (RS)2-(3-benzoylphenyl)-Propionic Acid | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Incidence of Lymphedema | Participants were evaluated every 3 months up to one year post lymph node dissection | Posted | Count of Participants | Participants | Up to 1 year |
|
Enrollment to 1 year post axillary lymph node dissection.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | (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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swollen thumb | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Roche, RN | Stanford University | 650-723-1396 | lesroche@stanford.edu |
Not provided
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| (RS)2-(3-benzoylphenyl)-propionic acid | Drug | Given PO |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Placebo for Study Drug |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | 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 | 0 | 7 | 1 | 7 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | 2 days of mild abdominal pain, resolved spontaneously |
|
Not provided
Not provided