We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has suspended participant recruitment.
(study endpoints met)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02257970
First Posted: October 7, 2014
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanley Rockson, Stanford University
August 25, 2014
October 7, 2014
March 13, 2017
March 2009
December 2016   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02257970 on ClinicalTrials.gov Archive Site
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.
Same as current
Limb volume [ Time Frame: at 4 months ]
Assessment of limb volume of the affected arm or leg at study end.
Same as current
 
Placebo-controlled Lymphedema Study for Arm or Leg Lymphedema
Case-controlled, Open Label Therapeutic Trial for Unilateral or Bilateral Lymphedema of Arm or Leg.
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 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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lymphedema
  • Drug: oral anti-inflammatory drug
    1 capsule, three times a day, for four months
    Other Name: anti-inflammatory oral medication
  • Drug: Placebo
    1 capsule, three times a day, for four months
    Other Name: sugar pill
  • Experimental: oral anti-inflammatory drug
    anti-inflammatory oral drug, 1 capsule, three times/day, for 4 months
    Intervention: Drug: oral anti-inflammatory drug
  • Placebo Comparator: Placebo
    Placebo, 1 capsule, three times/day, for 4 months
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
150
December 2017
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02257970
7781
No
Not Provided
Plan to Share IPD: Undecided
Plan Description: grouped data may be shared
Stanley Rockson, Stanford University
Stanford University
Not Provided
Principal Investigator: Stanley G Rockson, MD Stanford University
Stanford University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP