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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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