Trial Outcomes & Findings for Low Level Laser Treatment and Breast Cancer Related Lymphedema (NCT NCT00852930)
NCT ID: NCT00852930
Last Updated: 2017-04-11
Results Overview
Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Low Level Laser Treatment and Breast Cancer Related Lymphedema
Baseline characteristics by cohort
| Measure |
Laser Therapy Alone
n=15 Participants
therapist administered laser treatment
laser: therapist administered laser
|
Mld Alone
n=16 Participants
therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy
|
Laser and Mld Combined
n=15 Participants
therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 11.3 • n=93 Participants
|
67.5 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
66.0 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
66.6 years
STANDARD_DEVIATION 10.2 • n=483 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
16 participants
n=4 Participants
|
15 participants
n=27 Participants
|
46 participants
n=483 Participants
|
|
Time from surgery to lymphedema diagnosis
|
7.2 months
n=93 Participants
|
14.8 months
n=4 Participants
|
30.0 months
n=27 Participants
|
11.1 months
n=483 Participants
|
|
Duration of lymphedema prior to study enrollment
|
27.0 months
n=93 Participants
|
18.9 months
n=4 Participants
|
25.2 months
n=27 Participants
|
25.4 months
n=483 Participants
|
PRIMARY outcome
Timeframe: Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.Population: LDex units.
Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.
Outcome measures
| Measure |
Laser Therapy Alone
n=15 Participants
therapist administered laser treatment
laser: therapist administered laser
|
Mld Alone
n=16 Participants
therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy
|
Laser and Mld Combined
n=15 Participants
therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment
|
|---|---|---|---|
|
LDex Change-
|
28.0 LDex
Interval 17.0 to 35.0
|
17.8 LDex
Interval 3.0 to 38.0
|
22.2 LDex
Interval 11.0 to 37.0
|
PRIMARY outcome
Timeframe: Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.Whole arm measurement to determine volume.
Outcome measures
| Measure |
Laser Therapy Alone
n=15 Participants
therapist administered laser treatment
laser: therapist administered laser
|
Mld Alone
n=16 Participants
therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy
|
Laser and Mld Combined
n=15 Participants
therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment
|
|---|---|---|---|
|
Whole Arm Volume Difference
|
15.0 Whole Arm Volume % Difference
Interval 3.0 to 23.0
|
6.8 Whole Arm Volume % Difference
Interval 0.0 to 17.0
|
13.4 Whole Arm Volume % Difference
Interval 2.0 to 24.0
|
SECONDARY outcome
Timeframe: Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.Population: Total number of reported symptoms. Range of symptoms reported could be 0 to 36. Greater number of symptoms represents worse outcome.
Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.
Outcome measures
| Measure |
Laser Therapy Alone
n=15 Participants
therapist administered laser treatment
laser: therapist administered laser
|
Mld Alone
n=16 Participants
therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy
|
Laser and Mld Combined
n=15 Participants
therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment
|
|---|---|---|---|
|
Symptoms
|
12 symptoms
Interval 4.0 to 16.0
|
12.5 symptoms
Interval 6.0 to 16.0
|
14 symptoms
Interval 10.0 to 19.0
|
SECONDARY outcome
Timeframe: Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.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.
Outcome measures
| Measure |
Laser Therapy Alone
n=15 Participants
therapist administered laser treatment
laser: therapist administered laser
|
Mld Alone
n=16 Participants
therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy
|
Laser and Mld Combined
n=15 Participants
therapist administered laser and mld
Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment
|
|---|---|---|---|
|
Quality of Life
|
113.5 total score
Interval 100.0 to 129.0
|
116.25 total score
Interval 98.0 to 123.0
|
110 total score
Interval 102.0 to 123.0
|
Adverse Events
Laser Therapy Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mld Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laser and Mld Combined
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sheila H, Ridner, PHD
Vanderbilt University School of Nursing
Phone: 615-322-0831
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place