Trial Outcomes & Findings for LLLT Combined With CDT in Breast Cancer-Related Lymphedema (NCT NCT01351376)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

13 Months

Results posted on

2019-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo CDT + inactive LLL Low Level Laser Therapy: Placebo LLL combined with CDT	LLL Combined With CDT CDT + active LLL Low Level Laser: Active LLL combined with CDT
Overall Study STARTED	10	11
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LLLT Combined With CDT in Breast Cancer-Related Lymphedema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=10 Participants CDT + inactive LLL Low Level Laser Therapy: Placebo LLL combined with CDT	LLL Combined With CDT n=11 Participants CDT + active LLL Low Level Laser: Active LLL combined with CDT	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 13 Months

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants CDT + inactive LLL Low Level Laser Therapy: Placebo LLL combined with CDT	LLL Combined With CDT n=11 Participants CDT + active LLL Low Level Laser: Active LLL combined with CDT
Arm Volume	1.48 cm^3 Standard Deviation 1.01	1.58 cm^3 Standard Deviation 1.0

SECONDARY outcome

Timeframe: 13 months

Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants CDT + inactive LLL Low Level Laser Therapy: Placebo LLL combined with CDT	LLL Combined With CDT n=11 Participants CDT + active LLL Low Level Laser: Active LLL combined with CDT
Short-Form Health Survey (SF-36)	75.5085 score on a scale Standard Deviation 16.07351	72.6042 score on a scale Standard Deviation 18.01269

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LLL Combined With CDT

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

Tara Denham, MD

Rehabilitation Medicine, New York University School of Medicine

Phone: 212 263 8240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place