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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nathalie Johnson, Legacy Health System
ClinicalTrials.gov Identifier:
NCT01006408
First received: November 1, 2009
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Peripheral Neuropathy
Procedure: Low Level Laser
Procedure: Placebo followed by Low Level Laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Legacy Health System:

Enrollment: 20
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Level Laser
Low Level Laser twice a week for 8 weeks
Procedure: Low Level Laser
Low Level Laser twice a week for 8 weeks
Sham Comparator: Placebo and Low Level Laser
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
Placebo twice a week for 4 weeks then crossover to Low Level Laser twice a week for 4 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006408

Locations
United States, Oregon
Legacy Good Samaritan Medical Center
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Legacy Health System
  More Information

No publications provided

Responsible Party: Nathalie Johnson, Principal investigator, Legacy Health System
ClinicalTrials.gov Identifier: NCT01006408     History of Changes
Other Study ID Numbers: LLLT-001
Study First Received: November 1, 2009
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Legacy Health System:
Neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 14, 2014