Ignite Creation Date:
2024-05-05 @ 10:00 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01006408
Status:
COMPLETED
Last Update Posted:
2012-10-19
First Post:
2009-11-01
Brief Title:
Treatment Trial Using Low Level Laser Therapy LLLT for Treatment of Chemotherapy Induced Peripheral Neuropathy
Sponsor:
Legacy Health System
Organization:
Legacy Health System
Study Overview
Official Title:
Pilot Single Center Randomized Double Blind Placebo Controlled Single Crossover Treatment Trial Using Low Level Laser Therapy LLLT for Treatment of Chemotherapy Induced Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LLL
Brief Summary:
The purpose of this research study is to determine if treatment with Low Level Laser Therapy LLLT is effective in treating the pain numbness or tingling patients are experiencing following their chemotherapy The investigators would also like to know the number of treatments that were needed in order to reduce their symptoms
Detailed Description:
LLLT is a technique of applying a low energy or low-level laser to tissue It is used to trigger tissue to increase cellular production by giving off a low-level or cold light energy This low level energy passes through the skin into the cell membrane producing a process called photobiostimulation LLLT works by capturing and increasing the beneficial wavelengths of light These lasers do not cut or burn but instead penetrate into the skin This process has multiple effects on cells and can enhance the bodys natural regenerative functions It can also stimulate the release of endorphins and collagen Endorphins work as natural pain relievers and are produced by the body during strenuous workouts excitement and pain Collagen is a natural substance within body tissues
This is a single center trial conducted at Legacy Health System Twenty patients from Legacy Health System with chemo-induced peripheral neuropathy will be enrolled in this study Arm 1 will receive LLLT twice a week for a total of eight weeks Arm 2 will follow a crossover study design where patients will receive sham fake LLLT twice a week for the first four weeks followed by true LLLT twice a week for four weeks total of 8 weeks Each patient in Arm 2 will serve as his or her own comparison for the purpose of examining the effects of LLLT Both arms will have a follow-up visit following the last treatment
This is a single center trial conducted at Legacy Health System Twenty patients from Legacy Health System with chemo-induced peripheral neuropathy will be enrolled in this study Arm 1 will receive LLLT twice a week for a total of eight weeks Arm 2 will follow a crossover study design where patients will receive sham fake LLLT twice a week for the first four weeks followed by true LLLT twice a week for four weeks total of 8 weeks Each patient in Arm 2 will serve as his or her own comparison for the purpose of examining the effects of LLLT Both arms will have a follow-up visit following the last treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None