Chemotherapy-induced Peripheral NeuropathyNCT02000908
Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy
A study testing photobiomodulation and Physiotherapy in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Minnesota at 1 site in United States.
Trial summary
This is a 2-armed, randomized, sham-controlled, double-blinded clinical trial of photobiomodulation therapy using the Realief Therapy system. The patients will be randomized in a 3:4 ratio to treatment or sham arms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- photobiomodulation and Physiotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 6 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will have stable or worsening neuropathy (≥grade 2 CTCAE) after the completion of chemotherapy, with a presumptive remission. Patients who are interested in enrollment will have a baseline neuropathy assessment followed by a second evaluation 1 month later to confirm that the neuropathy is not spontaneously improving (greater than 10% improvement in their mTNS).
- Patients will be 18 years or older at the time of signing the consent.
- Patients must have GOG performance status of 0, 1, 2, or 3 (see appendix III), and be able to communicate both their symptoms and report the response to neurologic testing.
- Patients must have recovered from the acute and remediable effects of surgery, radiation therapy and/or chemoradiotherapy. At least 3 weeks must have elapsed from the last administration of chemotherapy, and at least three weeks must have elapsed from the last administration of a complete radiation therapy regimen alone or chemoradiation therapy.
- Patients with pre-existing neuropathy will be eligible, provided that they have not previously undergone laser therapy for the treatment of their condition.
- Patients must be sterile or on adequate birth control.
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- Patients must have willingly signed an approved consent form, be willing to be randomized to intervention or sham therapy, and be willing to be blinded from directly observing therapy. Patients completing sham therapy will be offered Realief Therapy in conjunction with physiotherapy free of charge.
- Patients must be able to attend therapy at the Realief Neuropathy Center in St. Louis Park as dictated by the requirements of the protocol (3 times/week for up to 8 weeks as well as once 8 weeks following the completion of therapy) AND be evaluated at the University of Minnesota's Gynecologic Cancer Clinic for study assessments (4 planned assessments during and after therapy). Every effort will be made to co-ordinate these visits with routine health maintenance.
- Life expectancy >6 months
Who cannot join
- Patients who have previously received a laser-based therapy for the treatment of neuropathy will be considered ineligible.
- Patients with a > 10% improvement from the initial mTNS assessment to the mTNS assessment at the time of study enrollment (four weeks from the original assessment).
- Patients with evidence of direct tumor involvement of the nervous system (central or peripheral) will be considered ineligible.
- Patients who are pregnant will be considered ineligible. Class 4 lasers have been inadequately studied in this setting to conclude that there is no risk to a developing fetus.
- Patients with the inability to tolerate therapy or blinding due to co-morbid medical or psychiatric illness.
- Patients in active treatment of cancer will not be considered eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Gynecologic Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Prospective, Randomized, Double Blind Study of Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy
This is a 2-armed, randomized, sham-controlled, double-blinded clinical trial of photobiomodulation therapy using the Realief Therapy system. The patients will be randomized in a 3:4 ratio to treatment or sham arms.
Read the detailed description
The treatments will be administered by a Realief Neuropathy Center therapist. The target surface area and treatment durations will be dictated by the Realief Therapy protocol according to their proprietary algorithm, which includes assessment of geographic areas involved and the degree of neuropathy experienced. For the trial, each patient will be given 18 treatments of 30-minute duration, scheduled every three times weekly. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy.
- Being tested
- photobiomodulation, Sham treatment, Physiotherapy
- Keywords
- gynecological cancer, ovarian cancer, primary peritoneal cancer, cervical caner, peripheral neuropathy
- Medical subject headings
- Ovarian Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationDevice
The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser.
Sham treatmentOther
All patients in sham treatment arm cross over to laser therapy followed by physiotherapy
PhysiotherapyOther
Chiropractic massage and lymphedema treatment
| Study group | Role | What they receive |
|---|---|---|
| Realief Therapy | Experimental | Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy. Receives: Device: photobiomodulation |
| Sham Treatment | Sham comparator | The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control.
After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy. Receives: Device: photobiomodulation; Other: Sham treatment; Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Total Neuropathy Score
For each patient, we will compute the difference between the total neuropathy score at 8 weeks (the end of treatment) and the total neuropathy score at the time of randomization. The mean change in score for the experimental group patients will be compared to the mean change in score for the control group patients using a two-sample t-test.
Scale scoring is 0-<20 0 being no pain <20 =severe
Measured: Baseline 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2014
- Primary completion7 Jan 2016
- Study completion6 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Argenta, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000908
- Sponsor's protocol ID
- 2013LS085
- Other IDs
- WCC# 63
- Status last verified
- Feb 2019
- First submitted
- 27 Nov 2013
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blind Study of Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT02000908
- Acronym / sponsor ID
- 2013LS085
- Keywords
- gynecological cancer, ovarian cancer, primary peritoneal cancer, cervical caner, peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 7 Jan 2016 (actual)
- Study completion
- 6 Jan 2017 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-armed, randomized, sham-controlled, double-blinded clinical trial of photobiomodulation therapy using the Realief Therapy system. The patients will be randomized in a 3:4 ratio to treatment or sham arms.
Detailed description
The treatments will be administered by a Realief Neuropathy Center therapist. The target surface area and treatment durations will be dictated by the Realief Therapy protocol according to their proprietary algorithm, which includes assessment of geographic areas involved and the degree of neuropathy experienced. For the trial, each patient will be given 18 treatments of 30-minute duration, scheduled every three times weekly. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Realief Therapy | Experimental | Device: photobiomodulationEach patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy. |
| Sham Treatment | Sham comparator | Device: photobiomodulation, Other: Sham treatment, Other: PhysiotherapyThe placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control. After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients will have stable or worsening neuropathy (≥grade 2 CTCAE) after the completion of chemotherapy, with a presumptive remission. Patients who are interested in enrollment will have a baseline neuropathy assessment followed by a second evaluation 1 month later to confirm that the neuropathy is not spontaneously improving (greater than 10% improvement in their mTNS).
- Patients will be 18 years or older at the time of signing the consent.
- Patients must have GOG performance status of 0, 1, 2, or 3 (see appendix III), and be able to communicate both their symptoms and report the response to neurologic testing.
- Patients must have recovered from the acute and remediable effects of surgery, radiation therapy and/or chemoradiotherapy. At least 3 weeks must have elapsed from the last administration of chemotherapy, and at least three weeks must have elapsed from the last administration of a complete radiation therapy regimen alone or chemoradiation therapy.
- Patients with pre-existing neuropathy will be eligible, provided that they have not previously undergone laser therapy for the treatment of their condition.
Key exclusion criteria (6 listed)
- Patients who have previously received a laser-based therapy for the treatment of neuropathy will be considered ineligible.
- Patients with a > 10% improvement from the initial mTNS assessment to the mTNS assessment at the time of study enrollment (four weeks from the original assessment).
- Patients with evidence of direct tumor involvement of the nervous system (central or peripheral) will be considered ineligible.
- Patients who are pregnant will be considered ineligible. Class 4 lasers have been inadequately studied in this setting to conclude that there is no risk to a developing fetus.
- Patients with the inability to tolerate therapy or blinding due to co-morbid medical or psychiatric illness.
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 |
|---|---|---|
| photobiomodulationThe photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. | Device | Realief Therapy, Sham Treatment |
| Sham treatmentAll patients in sham treatment arm cross over to laser therapy followed by physiotherapy | Other | Sham Treatment |
| PhysiotherapyChiropractic massage and lymphedema treatment | Other | Sham Treatment |
Primary outcome
Change of Total Neuropathy Score
Time frame: Baseline 8 weeks
For each patient, we will compute the difference between the total neuropathy score at 8 weeks (the end of treatment) and the total neuropathy score at the time of randomization. The mean change in score for the experimental group patients will be compared to the mean change in score for the control group patients using a two-sample t-test. Scale scoring is 0-<20 0 being no pain <20 =severe
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Peter Argenta, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photobiomodulation and Physiotherapy in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Minnesota 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 9 inclusion and 6 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 11 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Change of Total Neuropathy Score (time frame: Baseline 8 weeks). It is what the study was designed to measure, not a finding.
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 11 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.