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Low Level Laser Treatment and Breast Cancer Related Lymphedema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheila H. Ridner, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00852930
First received: February 26, 2009
Last updated: November 30, 2015
Last verified: November 2015
Results First Received: July 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphedema
Interventions: Procedure: laser and MLD combined
Procedure: laser alone
Procedure: manual lymphatic drainage

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Laser Therapy Alone

therapist administered laser treatment

laser: therapist administered laser

Mld Alone

therapist administered manual lymphatic drainage

manual lymphatic drainage: therapist administered massage therapy

Laser and Mld Combined

therapist administered laser and mld

Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment


Participant Flow:   Overall Study
    Laser Therapy Alone   Mld Alone   Laser and Mld Combined
STARTED   16   17   17 
COMPLETED   15   16   15 
NOT COMPLETED   1   1   2 
Withdrawal by Subject                1                1                1 
Physician Decision                0                0                1 



  Baseline Characteristics
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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.
breast cancer survivors with known lymphedema

Reporting Groups
  Description
Laser Therapy Alone

therapist administered laser treatment

laser: therapist administered laser

Mld Alone

therapist administered manual lymphatic drainage

manual lymphatic drainage: therapist administered massage therapy

Laser and Mld Combined

therapist administered laser and mld

Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment

Total Total of all reporting groups

Baseline Measures
   Laser Therapy Alone   Mld Alone   Laser and Mld Combined   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   16   15   46 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.4  (11.3)   67.5  (10.3)   66.0  (10.2)   66.6  (10.2) 
Gender 
[Units: Participants]
       
Female   15   16   15   46 
Male   0   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   0   0   0   0 
Not Hispanic or Latino   15   15   15   45 
Unknown or Not Reported   0   1   0   1 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   1   1   0   2 
White   14   15   15   44 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   15   16   15   46 
Time from surgery to lymphedema diagnosis 
[Units: Months]
Median (Inter-Quartile Range)
 7.2 
 (4 to 27) 
 14.8 
 (5 to 108) 
 30.0 
 (2 to 84) 
 11.1 
 (3 to 73) 
Duration of lymphedema prior to study enrollment 
[Units: Months]
Median (Inter-Quartile Range)
 27.0 
 (6 to 58) 
 18.9 
 (5 to 73) 
 25.2 
 (6 to 142) 
 25.4 
 (6 to 86) 


  Outcome Measures
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1.  Primary:   LDex Change-   [ Time Frame: Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks. ]

2.  Primary:   Whole Arm Volume Difference   [ Time Frame: Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks. ]

3.  Secondary:   Symptoms   [ Time Frame: Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks. ]

4.  Secondary:   Quality of Life   [ Time Frame: Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Sheila H, Ridner, PHD
Organization: Vanderbilt University School of Nursing
phone: 615-322-0831
e-mail: Sheila.Ridner@Vanderbilt.edu



Responsible Party: Sheila H. Ridner, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00852930     History of Changes
Other Study ID Numbers: 090118
Study First Received: February 26, 2009
Results First Received: July 17, 2015
Last Updated: November 30, 2015
Health Authority: United States: Institutional Review Board