Peripheral NeuropathyLLLNCT01006408
Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral Neuropathy
A study testing Low Level Laser in people with Peripheral Neuropathy, run by Legacy Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Low Level Laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- < 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Neuropathy
- Being tested
- Low Level Laser, Placebo followed by Low Level Laser
- Keywords
- Neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level LaserProcedure or surgery
Low Level Laser twice a week for 8 weeks
Placebo followed by Low Level LaserProcedure or surgery
Placebo twice a week for 4 weeks then crossover to Low Level Laser twice a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser | Active comparator | Low Level Laser twice a week for 8 weeks Receives: 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 Receives: Procedure: Placebo followed by Low Level Laser |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie Johnson, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006408
- Sponsor's protocol ID
- LLLT-001
- Acronym
- LLL
- Status last verified
- Oct 2012
- First submitted
- 1 Nov 2009
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01006408
- Acronym / sponsor ID
- LLL / LLLT-001
- Conditions
- Peripheral Neuropathy
- Keywords
- Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser | Active comparator | Procedure: Low Level LaserLow Level Laser twice a week for 8 weeks |
| Placebo and Low Level Laser | Sham comparator | Procedure: Placebo followed by Low Level LaserPlacebo twice a week for 4 weeks then crossover to Low Level Laser twice a week for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (15 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level LaserLow Level Laser twice a week for 8 weeks | Procedure or surgery | Low Level Laser |
| Placebo followed by Low Level LaserPlacebo twice a week for 4 weeks then crossover to Low Level Laser twice a week for 4 weeks | Procedure or surgery | Placebo and Low Level Laser |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser in people with Peripheral Neuropathy, run by Legacy Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2012.