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Placebo-controlled Lymphedema Study for Arm or Leg Lymphedema (PB)

This study has suspended participant recruitment.
(study endpoints met)
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University
ClinicalTrials.gov Identifier:
NCT02257970
First received: August 25, 2014
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
This study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema to the untreated condition, in the same individual..

Condition Intervention Phase
Lymphedema
Drug: oral anti-inflammatory drug
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Case-controlled, Open Label Therapeutic Trial for Unilateral or Bilateral Lymphedema of Arm or Leg.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Amelioration of cutaneous histological architecture [ Time Frame: at 4 months ]
    Change in cutaneous histological architecture noted by examination of skin punch biopsy samples, normal and lymphedema samples


Secondary Outcome Measures:
  • Bioimpedance readings [ Time Frame: at 4 months ]
    If unilateral, a significant improvement in bioimpedance readings of the affected arm or leg compared to those of the normal arm or leg, at study end.


Other Outcome Measures:
  • Limb volume [ Time Frame: at 4 months ]
    Assessment of limb volume of the affected arm or leg at study end.


Estimated Enrollment: 150
Study Start Date: March 2009
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral anti-inflammatory drug
anti-inflammatory oral drug, 1 capsule, three times/day, for 4 months
Drug: oral anti-inflammatory drug
1 capsule, three times a day, for four months
Other Name: anti-inflammatory oral medication
Placebo Comparator: Placebo
Placebo, 1 capsule, three times/day, for 4 months
Drug: Placebo
1 capsule, three times a day, for four months
Other Name: sugar pill

Detailed Description:
This study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema to the untreated condition, in the same individual. This will be accomplished by obtaining four biopsies (small pieces of skin from your arm or leg), before treatment and after treatment. We will try to determine how the study drug affects the body tissue. Patients who participate in this study will be randomly assigned (like flipping a coin) to receive either the study drug or a placebo, which is an inactive substance which may resemble an active agent, but has no medical value. Every participant will have a 50:50 chance of receiving the study drug.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a history of lymphedema of one or more limbs (unilateral or bilateral), with a duration of > 6 months.

Exclusion Criteria:

  • Patients with active cancer, infection or bleeding tendency will be excluded.
  • We will also exclude patients with medical contraindications to NSAIDs, including history of allergies, know gastrointestinal intolerance, or 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.
  • Minors (<18 years of age) *>90 years of age
  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: NCT02257970

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley G Rockson, MD Stanford University
  More Information

Additional Information:
Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine; Professor of Cardiovascular Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02257970     History of Changes
Other Study ID Numbers: 7781
Study First Received: August 25, 2014
Last Updated: March 9, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: grouped data may be shared

Keywords provided by Stanford University:
Lymphedema
edema
swelling

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 24, 2017