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

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.

Inclusion Criteria:

1. Inclusion > 18 years of age

2. Male or Female

3. History of Cancer

4. Naive to LLLT

5. Completed chemotherapy between > 2 weeks & < 12 weeks OR > 9 months OR (pain or
tingling in the upper or lower extremities beginning in association with cancer
chemotherapy agent and persisting for at lease 28 days following conclusion of the
chemotherapy. Pain can be assessed 28 days or more after the conclusion of
chemotherapy)

6. Not pregnant

7. Consents to study participation

8. English Speaking

9. Minimal ambulatory with walker/cane or independent for 50 feet

10. Symptoms of neuropathy, including paresthesias, numbness and/or tingling of feet,
toes and/or hands, fingers

Exclusion Criteria:

1. < 18 years of age

2. Previous treatment with LLLT

3. Neuropathy before chemotherapy

4. Current use of any topical treatment, nerve blocks, implantable therapy, or
peripheral nerve or spinal cord stimulation, and neurosurgical procedure for painful
CIPN

5. Subject who will not agree to maintain systemic pain treatments at stable dosages
during the conduct of the study.

6. Adjunctive analgesic therapy such as acupuncture, biofeedback, or herbal preparations
that has not been stable for at least 2 weeks

7. Subjects receiving an unapproved experimental drug or biological agent within 30 days
of the screening visit

8. Subjects unable to complete assessment forms

9. Wheelchair dependent or non-ambulatory

10. Clinically significant depression or dementia that, in the opinion of the
investigator, may interfere with a subjects' adherence to the study protocol and/or
the accurate and consistent reporting of pain.

11. ETOH abuse as determined by the investigator

12. Open skin lesions in the area where the LLLT will be applied

13. Pregnant or lactating

14. Refuse to consent to trial participation

15. < 2 or > 12 weeks post chemotherapy OR between > 12 weeks and < 9 months post
chemotherapy