Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in Patients At High Risk After Undergoing Axillary Lymph Node Dissection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University
ClinicalTrials.gov Identifier:
NCT01893879
First received: July 2, 2013
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Lymphedema
Unspecified Adult Solid Tumor, Protocol Specific
Other: placebo
Drug: study drug
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Incidence of lymphedema and/or severity of lymphedema [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2014
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (study drug)
Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Drug: study drug
Given PO
Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.
Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893879

Locations
United States, California
Stanford University Hospitals and Clinics Not yet recruiting
Stanford, California, United States, 94305
Contact: Stanley Rockson    650-498-7061    srockson@cvmed.stanford.edu   
Principal Investigator: Stanley Rockson         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley Rockson Stanford University Hospitals and Clinics
  More Information

No publications provided

Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01893879     History of Changes
Other Study ID Numbers: BRSNSTU0028
Study First Received: July 2, 2013
Last Updated: August 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014