Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Level Laser Treatment and Breast Cancer Related Lymphedema

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.
ClinicalTrials.gov Identifier: NCT00852930
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : November 2, 2015
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sheila Ridner, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphedema
Interventions Procedure: laser and MLD combined
Procedure: laser alone
Procedure: manual lymphatic drainage
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laser Therapy Alone Mld Alone Laser and Mld Combined
Hide Arm/Group Description

therapist administered laser treatment

laser: therapist administered laser

therapist administered manual lymphatic drainage

manual lymphatic drainage: therapist administered massage therapy

therapist administered laser and mld

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

Period Title: Overall Study
Started 16 17 17
Completed 15 16 15
Not Completed 1 1 2
Reason Not Completed
Withdrawal by Subject             1             1             1
Physician Decision             0             0             1
Arm/Group Title Laser Therapy Alone Mld Alone Laser and Mld Combined Total
Hide Arm/Group Description

therapist administered laser treatment

laser: therapist administered laser

therapist administered manual lymphatic drainage

manual lymphatic drainage: therapist administered massage therapy

therapist administered laser and mld

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

Total of all reporting groups
Overall Number of Baseline Participants 15 16 15 46
Hide Baseline Analysis Population Description
breast cancer survivors with known lymphedema
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 15 participants 46 participants
66.4  (11.3) 67.5  (10.3) 66.0  (10.2) 66.6  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 15 participants 46 participants
Female
15
 100.0%
16
 100.0%
15
 100.0%
46
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 15 participants 46 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
15
 100.0%
15
  93.8%
15
 100.0%
45
  97.8%
Unknown or Not Reported
0
   0.0%
1
   6.3%
0
   0.0%
1
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 15 participants 46 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.7%
1
   6.3%
0
   0.0%
2
   4.3%
White
14
  93.3%
15
  93.8%
15
 100.0%
44
  95.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 16 participants 15 participants 46 participants
15 16 15 46
Time from surgery to lymphedema diagnosis  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 15 participants 16 participants 15 participants 46 participants
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  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 15 participants 16 participants 15 participants 46 participants
27.0
(6 to 58)
18.9
(5 to 73)
25.2
(6 to 142)
25.4
(6 to 86)
1.Primary Outcome
Title LDex Change-
Hide Description Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
LDex units.
Arm/Group Title Laser Therapy Alone Mld Alone Laser and Mld Combined
Hide Arm/Group Description:

therapist administered laser treatment

laser: therapist administered laser

therapist administered manual lymphatic drainage

manual lymphatic drainage: therapist administered massage therapy

therapist administered laser and mld

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

Overall Number of Participants Analyzed 15 16 15
Median (Inter-Quartile Range)
Unit of Measure: LDex
28.0
(17 to 35)
17.8
(3 to 38)
22.2
(11 to 37)
2.Primary Outcome
Title Whole Arm Volume Difference
Hide Description Whole arm measurement to determine volume.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laser Therapy Alone Mld Alone Laser and Mld Combined
Hide Arm/Group Description:

therapist administered laser treatment

laser: therapist administered laser

therapist administered manual lymphatic drainage (mld)

manual lymphatic drainage: therapist administered massage therapy

therapist administered laser and mld

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

Overall Number of Participants Analyzed 15 16 15
Median (Inter-Quartile Range)
Unit of Measure: Whole Arm Volume % Difference
15.0
(3 to 23)
6.8
(0 to 17)
13.4
(2 to 24)
3.Secondary Outcome
Title Symptoms
Hide Description Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.
Time Frame Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of reported symptoms. Range of symptoms reported could be 0 to 36. Greater number of symptoms represents worse outcome.
Arm/Group Title Laser Therapy Alone Mld Alone Laser and Mld Combined
Hide Arm/Group Description:

therapist administered laser treatment

laser: therapist administered laser

therapist administered manual lymphatic drainage

manual lymphatic drainage: therapist administered massage therapy

therapist administered laser and mld

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

Overall Number of Participants Analyzed 15 16 15
Median (Inter-Quartile Range)
Unit of Measure: symptoms
12
(4 to 16)
12.5
(6 to 16)
14
(10 to 19)
4.Secondary Outcome
Title Quality of Life
Hide Description The Functional Assessment of Chronic Illness Therapy that measure quality of life -total score. Range of scores could be 0 to 148. Higher score represents higher 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laser Therapy Alone Mld Alone Laser and Mld Combined
Hide Arm/Group Description:

therapist administered laser treatment

laser: therapist administered laser

therapist administered manual lymphatic drainage

manual lymphatic drainage: therapist administered massage therapy

therapist administered laser and mld

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

Overall Number of Participants Analyzed 15 16 15
Median (Inter-Quartile Range)
Unit of Measure: total score
113.5
(100 to 129)
116.25
(98 to 123)
110
(102 to 123)
Time Frame Participants were followed through the last treatment and there was an average of 9 treatments per group.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laser Therapy Alone Mld Alone Laser and Mld Combined
Hide Arm/Group Description

therapist administered laser treatment

laser: therapist administered laser

No adverse events during the study.

therapist administered manual lymphatic drainage

manual lymphatic drainage: therapist administered massage therapy

No adverse events during the study.

therapist administered laser and mld

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

No adverse events during the study.

All-Cause Mortality
Laser Therapy Alone Mld Alone Laser and Mld Combined
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Laser Therapy Alone Mld Alone Laser and Mld Combined
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Laser Therapy Alone Mld Alone Laser and Mld Combined
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%)   0/15 (0.00%) 
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
Responsible Party: Sheila Ridner, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00852930     History of Changes
Other Study ID Numbers: 090118
First Submitted: February 26, 2009
First Posted: February 27, 2009
Results First Submitted: July 17, 2015
Results First Posted: November 2, 2015
Last Update Posted: April 11, 2017