NCT01006408

Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral Neuropathy

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Legacy Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 body's 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.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
PROCEDURE	Low Level Laser	Low Level Laser twice a week for 8 weeks
PROCEDURE	Placebo followed by Low Level Laser	Placebo twice a week for 4 weeks then crossover to Low Level Laser twice a week for 4 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-11-02
• Last updated: 2012-10-19

Locations

1 site across 1 country: United States