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

Primary Purpose

Peripheral Neuropathy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low Level Laser

Placebo followed by Low Level Laser

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

< 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

Sites / Locations

Legacy Good Samaritan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Low Level Laser

Placebo and Low Level Laser

Arm Description

Low Level Laser twice a week for 8 weeks

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01006408

First Posted

November 1, 2009

Last Updated

October 17, 2012

Sponsor

Legacy Health System

1. Study Identification

Unique Protocol Identification Number

NCT01006408

Brief Title

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

Acronym

LLL

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Legacy Health System

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Neuropathy

Keywords

Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Level Laser

Arm Type

Active Comparator

Arm Description

Low Level Laser twice a week for 8 weeks

Arm Title

Placebo and Low Level Laser

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Low Level Laser

Intervention Description

Low Level Laser twice a week for 8 weeks

Intervention Type

Procedure

Intervention Name(s)

Placebo followed by Low Level Laser

Intervention Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: < 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

Facility Information:

Facility Name

Legacy Good Samaritan Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

12. IPD Sharing Statement

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

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