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

Stanford University

Status: Terminated

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Lymphedema

Treatments: Drug: placebo for study drug; Other: laboratory biomarker analysis; Drug: (RS)2-(3-benzoylphenyl)-propionic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01893879

BRSNSTU0028 (Other Identifier)

IRB-20651

4593 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups, including a placebo group

(RS)2-(3-benzoylphenyl)-propionic acid

Experimental 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.

Treatment:

Drug: (RS)2-(3-benzoylphenyl)-propionic acid

Other: laboratory biomarker analysis

placebo for study drug

Placebo Comparator group

Description:

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.

Treatment:

Other: laboratory biomarker analysis

Drug: placebo for study drug