Neuropathy, ParaneoplasticPhase 2NCT01261780

MC-5A for Chemotherapy Induced Peripheral Neuropathy

A Phase 2 study testing MC-5A in people with Neuropathy, Paraneoplastic, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer therapy with few treatment options. CIPN is a complex side effect that varies between individuals and can be difficult to describe, difficult to treat and can significantly effect quality of life for patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuropathy, Paraneoplastic
What is being tested?: MC-5A
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Sep 2012
Phase: Phase 2
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

painful peripheral neuropathy resulting from chemotherapy
pain must be present for minimum of 6 months
must be able to read/understand English
stable analgesics regimens allowed (no change for past 7 days)

Who cannot join

painful peripheral neuropathy that is not the result of chemotherapy
pregnant women
patients unable to wean off anti-epileptics
patients currently receiving chemotherapy known to cause peripheral neuropathy
patients with pacemakers or implanted defibrillators
patients with vena cava or aneurysm clips
patients with a history of epilepsy

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial

The purpose of this study is to determine if patients with painful CIPN will have a decrease in pain scores after treatment with the MC-5A device.

Conditions: Neuropathy, Paraneoplastic
Being tested: MC-5A, Sham device
Keywords: neuropathy,paraneoplastic, paraneoplastic peripheral neuropathy, pain, hyperalgesia
Medical subject headings: Paraneoplastic Polyneuropathy, Pain, Hyperalgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MC-5ADevice
Also called Scrambler therapy
45 minutes daily x 10 treatments (given over the course of 2 weeks)
Sham deviceDrug
Also called TRA-1
Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)

Study groups in NCT01261780
Study group	Role	What they receive
Sham device	Sham comparator	Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days Receives: Drug: Sham device
MC-5A treatment	Active comparator	MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days. Receives: Device: MC-5A

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)
Pain levels will be compared as measured by changes in mVAS, and quantified and tested for normal distribution. If normally distributed, parametric test (i.e., two-sample t-test) will be used; p-values <0.05 will be considered statistically significant. If changes in mVAS are not normally distributed, non-parametric testing such as Wilcoxon rank-sum will be performed. VAS is measured at 3 time points.
mVAS and deficits scale are used to obtain continuous quantitative information about positive and negative sensory phenomena during application of QSPT stimulation.
Patients provide rating of positive sensory phenomena using mVAS if the stimulus at the pain test site is increased or painful when compared to normal control site. Rating on mVAS is obtained by instructing the patient to pull out the mechanical scale with millimeters (looks like a slide ruler) to reflect intensity of any painful sensation on a scale of 0 - 10, with 10 being the worst. Score = Visit - Baseline.
Measured: Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)

Secondary outcomes (1)

Adverse Events
The number of participants experiencing adverse events, as defined by CTCAE
Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Sep 2012

First posted16 Dec 2010 (estimated)
Study startApr 2011
Primary completionSep 2012
Study completionSep 2012

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 Neuropathy, ParaneoplasticStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01261780
Sponsor's protocol ID: OS10328
Other IDs: 2010-0361, NCI-2012-00075, A534260, SMPH\MEDICINE\HEM-ONC
Status last verified: Oct 2017
First submitted: 9 Dec 2010
Last updated: 2 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial
ClinicalTrials.gov ID: NCT01261780
Acronym / sponsor ID: OS10328
Conditions: Neuropathy, Paraneoplastic
Keywords: neuropathy,paraneoplastic, paraneoplastic peripheral neuropathy, pain, hyperalgesia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: Apr 2011
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 16 Dec 2010 (estimated)
Results: Posted 6 Nov 2017

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 study is to determine if patients with painful CIPN will have a decrease in pain scores after treatment with the MC-5A device.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham device	Sham comparator	Drug: Sham deviceSham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days
MC-5A treatment	Active comparator	Device: MC-5AMC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

painful peripheral neuropathy resulting from chemotherapy
pain must be present for minimum of 6 months
must be able to read/understand English
stable analgesics regimens allowed (no change for past 7 days)

Key exclusion criteria (7 listed)

painful peripheral neuropathy that is not the result of chemotherapy
pregnant women
patients unable to wean off anti-epileptics
patients currently receiving chemotherapy known to cause peripheral neuropathy
patients with pacemakers or implanted defibrillators

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
MC-5AAlso: Scrambler therapy45 minutes daily x 10 treatments (given over the course of 2 weeks)	Device	MC-5A treatment
Sham deviceAlso: TRA-1Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)	Drug	Sham device

Primary outcome

Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)
Time frame: Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)
Pain levels will be compared as measured by changes in mVAS, and quantified and tested for normal distribution. If normally distributed, parametric test (i.e., two-sample t-test) will be used; p-values <0.05 will be considered statistically significant. If changes in mVAS are not normally distributed, non-parametric testing such as Wilcoxon rank-sum will be performed. VAS is measured at 3 time points. mVAS and deficits scale are used to obtain continuous quantitative information about positive and negative sensory phenomena during application of QSPT stimulation. Patients provide rating of positive sensory phenomena using mVAS if the stimulus at the pain test site is increased or painful when compared to normal control site. Rating on mVAS is obtained by instructing the patient to pull out the mechanical scale with millimeters (looks like a slide ruler) to reflect intensity of any painful sensation on a scale of 0 - 10, with 10 being the worst. Score = Visit - Baseline.

1 secondary outcome

Adverse Events
Time frame: Up to 3 months

Results and safety

Results posted to the registry on 6 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Device	7	5
MC-5A Treatment	7	5

Primary outcome: Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)

Time frame: Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks). Mean (Standard Deviation). Unit: Millimeters

Measure	Sham Device n = 7	MC-5A Treatment n = 6
Visit 1 (Day 1)	5.14 (29.1)	-2.00 (17.0)
Visit 10 (Day 10)	1.25 (2.50)	6.76 (24.7)
End of Study (Week 12, +/- 2 weeks)	-11.2 (5.36)	3.80 (3.42)

Population analysed: The number analyzed differs per row as some participants dropped out or did not receive all 10 treatments. For example, on the Sham Device arm, only 4 participants were treated on day 10 but 5 returned for the final visit. Because this was a pilot study, all participant data was analyzed and is included here.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected for up to 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Device	1 of 7 (14.3%)	4 of 7 (57.1%)	0 of 7
MC-5A Treatment	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7

Limitations and caveats (from the sponsor): The small sample size is subject to type II error. The estimated effect size for MC5A is high: the company estimates 100% of patients will respond. Thus our power calculations suggested a small sample could still detect a difference.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.

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.

Tony Campbell principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MC-5A in people with Neuropathy, Paraneoplastic, run by University of Wisconsin, Madison 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 4 inclusion and 7 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 2 Dec 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2017). 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 in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) (time frame: Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01261780.

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 2 Dec 2019; AzTrials last refreshed its copy on 31 Oct 2026.