Lymphedema, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
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.
Interventions
DRUGplacebo for study drug
Given PO
DRUG(RS)2-(3-benzoylphenyl)-propionic acid
Given PO
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incidence of Lymphedema | Up to 1 year | Participants were evaluated every 3 months up to one year post lymph node dissection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| (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 | 7 |
| 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 | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | (RS)2-(3-benzoylphenyl)-Propionic Acid | Placebo for Study Drug | Total |
|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 6 | 45.5 years STANDARD_DEVIATION 10.1 | 45.2 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment United States | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 7 | 1 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| (RS)2-(3-benzoylphenyl)-Propionic Acid | Number of Participants With Incidence of Lymphedema | 2 Participants |
| Placebo for Study Drug | Number of Participants With Incidence of Lymphedema | 1 Participants |