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Lymphedema Study for Arm or Leg Lymphedema

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ClinicalTrials.gov Identifier: NCT02257970
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lymphedema
Interventions: Drug: Ketoprofen
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Part 1 was feasibility, exploratory, open-label ketoprofen, to document effects. Part 2 was open-label trial of ketoprofen to document histological response. Part 3 was double-blind randomized to receive placebo or ketoprofen to evaluate safety and efficacy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Part 1: Exploratory Group

Ketoprofen 225-300 mgs daily, taken orally

Ketoprofen-exploratory group: 225-300 mgs daily for four to six months

Part 2: Open-label Group

Ketoprofen 225 mg daily, taken orally

Open-label group: 75 mgs, three times daily, for four months

Part 3: Placebo Group

Participants randomized to receive placebo: placebo, three times daily, taken orally

Placebo: 1 capsule, three times daily, for four months

Part 3: Ketoprofen Group

Participants randomized to receive active medication: ketoprofen 75 mgs., three times daily, taken orally

Ketoprofen: 1 capsule, three times daily, for four months


Participant Flow for 3 periods

Period 1:   Part 1
    Part 1: Exploratory Group   Part 2: Open-label Group   Part 3: Placebo Group   Part 3: Ketoprofen Group
STARTED   50   0   0   0 
COMPLETED   50   0   0   0 
NOT COMPLETED   0   0   0   0 

Period 2:   Part 2
    Part 1: Exploratory Group   Part 2: Open-label Group   Part 3: Placebo Group   Part 3: Ketoprofen Group
STARTED   0   23   0   0 
COMPLETED   0   16   0   0 
NOT COMPLETED   0   7   0   0 

Period 3:   Part 3
    Part 1: Exploratory Group   Part 2: Open-label Group   Part 3: Placebo Group   Part 3: Ketoprofen Group
STARTED   0   0   23   21 
COMPLETED   0   0   16   14 
NOT COMPLETED   0   0   7   7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants that completed the protocol were included in Baseline Characteristics.

Reporting Groups
  Description
Part 1: Exploratory Group

Ketoprofen 225-300 mgs daily, taken orally

Ketoprofen-exploratory group: 225-300 mgs daily for four to six months

Part 2: Open-label Group

Ketoprofen 225 mg daily

Open-label group: 75 mgs, 1 capsule, taken orally, three times daily, for four months

Part 3: Placebo Group

Participants randomized to receive placebo:

1 capsule, taken orally, three times daily, for four months

Part 3: Ketoprofen Group

Participants randomized to receive active medication, Ketoprofen 225 mg daily:

Ketoprofen: 75 mgs, 1 capsule, three times daily, for four months

Total Total of all reporting groups

Baseline Measures
   Part 1: Exploratory Group   Part 2: Open-label Group   Part 3: Placebo Group   Part 3: Ketoprofen Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   16   16   14   96 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      39  78.0%      12  75.0%      14  87.5%      10  71.4%      75  78.1% 
>=65 years      11  22.0%      4  25.0%      2  12.5%      4  28.6%      21  21.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.72  (13.46)   56.43  (11.15)   50.25  (15.12)   53.92  (13.14)   54.92  (13.07) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      41  82.0%      13  81.3%      14  87.5%      14 100.0%      82  85.4% 
Male      9  18.0%      3  18.8%      2  12.5%      0   0.0%      14  14.6% 
Lymphedema classification [1] 
[Units: Participants]
Count of Participants
         
Primary      4   8.0%      5  31.3%      4  25.0%      2  14.3%      15  15.6% 
Secondary      46  92.0%      11  68.8%      12  75.0%      12  85.7%      81  84.4% 
[1]

Primary lymphedema is defined as having been born with the condition, or developed the condition in the first year of life.

Secondary lymphedema is defined as a condition that results due to some other event (e.g., trauma, cancer treatment, May-Turner Syndrome (MTS)).

Lymphedema location 
[Units: Participants]
Count of Participants
         
Upper extermity      18  36.0%      4  25.0%      5  31.3%      2  14.3%      29  30.2% 
Lower extremity      32  64.0%      12  75.0%      11  68.8%      12  85.7%      67  69.8% 


  Outcome Measures

1.  Primary:   Part 1: Count of Participants Able to Complete Ketoprofen Treatment   [ Time Frame: Baseline to month 6 ]

2.  Primary:   Part 2: Change From Baseline in Cutaneous Histological Architecture   [ Time Frame: Baseline; Month 4 ]

3.  Primary:   Part 3: Measurement of Skin Thickness   [ Time Frame: Baseline and 4 months ]

4.  Secondary:   Part 2: Measurement of Skin Thickness   [ Time Frame: Baseline and 4 months ]

5.  Secondary:   Part 3: Change From Baseline in Cutaneous Histological Architecture   [ Time Frame: Baseline; 4 months ]

6.  Secondary:   Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy   [ Time Frame: Baseline; 4 months ]

7.  Secondary:   Part 2/Part 3: Change in Limb Volume   [ Time Frame: Baseline; 4 months ]

8.  Secondary:   Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)   [ Time Frame: Baseline; 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Stanley Rockson
Organization: Stanford University, School of Medicine
phone: 650-725-7571
e-mail: rockson@stanford.edu



Responsible Party: Stanley Rockson, Stanford University
ClinicalTrials.gov Identifier: NCT02257970     History of Changes
Other Study ID Numbers: 7781
First Submitted: August 25, 2014
First Posted: October 7, 2014
Results First Submitted: July 19, 2018
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018