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

Completed · Not applicable · Has a placebo group

Conditions studied: Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT01006408

Run by

Legacy Health System

People needed

20

Starts

2009-10-01

Expected to finish

2010-11-01

Last updated by the study team

2012-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion > 18 years of age
• Male or Female
• History of Cancer
• Naive to LLLT
• 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)
• Not pregnant
• Consents to study participation
• English Speaking
• Minimal ambulatory with walker/cane or independent for 50 feet
• Symptoms of neuropathy, including paresthesias, numbness and/or tingling of feet, toes and/or hands, fingers

You may not qualify if…

• < 18 years of age
• Previous treatment with LLLT
• Neuropathy before chemotherapy
• Current use of any topical treatment, nerve blocks, implantable therapy, or peripheral nerve or spinal cord stimulation, and neurosurgical procedure for painful CIPN
• Subject who will not agree to maintain systemic pain treatments at stable dosages during the conduct of the study.
• Adjunctive analgesic therapy such as acupuncture, biofeedback, or herbal preparations that has not been stable for at least 2 weeks
• Subjects receiving an unapproved experimental drug or biological agent within 30 days of the screening visit
• Subjects unable to complete assessment forms
• Wheelchair dependent or non-ambulatory
• 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.
• ETOH abuse as determined by the investigator
• Open skin lesions in the area where the LLLT will be applied
• Pregnant or lactating
• Refuse to consent to trial participation
• < 2 or > 12 weeks post chemotherapy OR between > 12 weeks and < 9 months post chemotherapy

Where it is running

• Legacy Good Samaritan Medical Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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