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

NCT01006408 | Completed

• 1 other identifier: LLLT-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy

Keywords

Neuropathy

Study Arms (2)

Low Level Laser

ACTIVE COMPARATOR

Low Level Laser twice a week for 8 weeks

Procedure: Low Level Laser

Placebo and Low Level Laser

SHAM COMPARATOR

Placebo twice a week for 4 weeks then crossover to Low Level Laser twice a week for 4 weeks

Procedure: Placebo followed by Low Level Laser

Interventions

Low Level Laser PROCEDURE

Low Level Laser twice a week for 8 weeks

Low Level Laser

Placebo followed by Low Level Laser PROCEDURE

Placebo twice a week for 4 weeks then crossover to Low Level Laser twice a week for 4 weeks

Placebo and Low Level Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Legacy Health System: lead

Study Sites (1)

Legacy Good Samaritan Medical Center

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 1, 2009
• First Posted: November 2, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

US (1)