Chemotherapeutic Agent ToxicityPhase 2NCT00952848
Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
A Phase 2 study testing questionnaire administration, Sensory Neuropathy Scale instrument and Quality of Life instrument in people with Chemotherapeutic Agent Toxicity and Neurotoxicity, run by Virginia Commonwealth University.
Trial summary
RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer. PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain
- What is being tested?
- questionnaire administration, Sensory Neuropathy Scale instrument and Quality of Life instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2009to Jun 2010
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Chemotherapy-induced peripheral neuropathy (CIPN) meeting the following criteria:
- More than 4 weeks since prior neurotoxic chemotherapy including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cis-platinum, oxaliplatin), vinca-alkaloids (e.g., vincristine, vinblastine, or vinorelbine), or proteosome inhibitors (e.g., bortezomib)
- Pain or symptoms of peripheral neuropathy for ≥ 1 month attributed to CIPN
- Pain stable for ≥ 2 weeks
- Average daily pain rating of ≥ 5 out of 10 using the pain numerical rating scale (0 is no pain and 10 is worst pain possible)
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of an allergic reaction or intolerance to transcutaneous electronic nerve stimulation
- No pacemaker or implantable drug-delivery system (e.g., Medtronic Synchromed)
- No heart stent or vena cava clips
- No history of epilepsy or brain damage
- No other identified causes of painful paresthesias existing before chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology [e.g., B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism, hypothyroidism, inherited neuropathy, etc.])
- No skin conditions (e.g., open sores) that would prevent proper application of the electrodes
- No other medical or other conditions that, in the opinion of the investigators, might compromise the objectives of the study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 30 days since prior and no concurrent investigational agents for pain control
- More than 4 weeks since prior and no concurrent celiac plexus block or other neurolytic pain control treatment
- No prior or concurrent anti-convulsants
- No concurrent neurotoxic or potentially neurotoxic chemotherapy
- Concurrent pain treatments allowed provided the following criteria are met:
- Pain is not satisfactorily controlled
- Dose of the other medication has been stable for ≥ 4 weeks
About this study
Official title: The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial
RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.
PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy.
Read the detailed description
OBJECTIVES:
Primary
- To determine if MC5-A Scrambler therapy will improve the pain associated with chemotherapy-induced peripheral neuropathy in cancer patients by 20%.
Secondary
- To evaluate the effect of MC5-A therapy on specific pain and neuropathy scales.
- To evaluate the effect of MC5-A therapy on overall quality of life.
- To evaluate the effect of MC5-A therapy on other pain drugs used.
- To evaluate the toxicities of MC5-A therapy.
OUTLINE: Patients undergo gel electrode application on the skin in the most pain-free of the pain-affected area. Patients undergo treatment with the MC5-A Scrambler machine over 60 minutes once daily on days 1-10. On day 1, the treatment intensity is increased every 10 minutes to the maximum intensity individually bearable by the patient without any input of pain or discomfort. The patient should feel the disappearance of the pain during treatment as a sign that the proper nerve pathway(s) has (have) been correctly identified. Subsequent treatments begin at the highest intensity tolerated at the previous treatment. Patients with no improvement after 3 treatments discontinue treatment.
Patients complete questionnaires about symptoms, pain, and quality of life periodically.
After completion of study treatment, patients are followed up at 2 and 4 weeks, monthly for 3 months, and at 6 months.
- Conditions
- Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- questionnaire administration, Sensory Neuropathy Scale instrument, Quality of Life instrument, MC5-A Scrambler device
- Keywords
- pain, neurotoxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific, peripheral neuropathy
- Medical subject headings
- Neurotoxicity Syndromes, Pain, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Pain Rating Score
Sensory Neuropathy Scale instrumentOther
ECOG Common Toxicity Criteria for Sensory Neuropathy scale
Quality of Life instrumentOther
Uniscale 0-100 scale global quality of life
MC5-A Scrambler deviceDevice
Electrical stimulation for 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| MC5-A Scramble instrument | Experimental | Treatment of chronic neuropathic pain with the MC5-A device Receives: Other: questionnaire administration; Other: Sensory Neuropathy Scale instrument; Other: Quality of Life instrument; Device: MC5-A Scrambler device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15.
Scale is 0 (none) to 10 (severe)
Measured: 15 days
Secondary outcomes (3)
Effect of MC5-A on Pain and Neuropathy
Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged.
Measured: 2 weeks
Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy
The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention
Measured: 2 weeks
Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument
Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study start12 Jun 2009
- Primary completionOct 2009
- Study completionJun 2010
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 Chemotherapeutic Agent ToxicityStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas J. Smith, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952848
- Sponsor's protocol ID
- CDR0000644516
- Other IDs
- MCV-MCC-12110
- Status last verified
- Feb 2017
- First submitted
- 4 Aug 2009
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial
- ClinicalTrials.gov ID
- NCT00952848
- Acronym / sponsor ID
- CDR0000644516
- Conditions
- Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- pain, neurotoxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific, peripheral neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Jun 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 22 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.
PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy.
Detailed description
OBJECTIVES:
Primary
- To determine if MC5-A Scrambler therapy will improve the pain associated with chemotherapy-induced peripheral neuropathy in cancer patients by 20%.
Secondary
- To evaluate the effect of MC5-A therapy on specific pain and neuropathy scales.
- To evaluate the effect of MC5-A therapy on overall quality of life.
- To evaluate the effect of MC5-A therapy on other pain drugs used.
- To evaluate the toxicities of MC5-A therapy.
OUTLINE: Patients undergo gel electrode application on the skin in the most pain-free of the pain-affected area. Patients undergo treatment with the MC5-A Scrambler machine over 60 minutes once daily on days 1-10. On day 1, the treatment intensity is increased every 10 minutes to the maximum intensity individually bearable by the patient without any input of pain or discomfort. The patient should feel the disappearance of the pain during treatment as a sign that the proper nerve pathway(s) has (have) been correctly identified. Subsequent treatments begin at the highest intensity tolerated at the previous treatment. Patients with no improvement after 3 treatments discontinue treatment.
Patients complete questionnaires about symptoms, pain, and quality of life periodically.
After completion of study treatment, patients are followed up at 2 and 4 weeks, monthly for 3 months, and at 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MC5-A Scramble instrument | Experimental | Other: questionnaire administration, Other: Sensory Neuropathy Scale instrument, Other: Quality of Life instrument, Device: MC5-A Scrambler deviceTreatment of chronic neuropathic pain with the MC5-A device |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| questionnaire administrationPain Rating Score | Other | MC5-A Scramble instrument |
| Sensory Neuropathy Scale instrumentECOG Common Toxicity Criteria for Sensory Neuropathy scale | Other | MC5-A Scramble instrument |
| Quality of Life instrumentUniscale 0-100 scale global quality of life | Other | MC5-A Scramble instrument |
| MC5-A Scrambler deviceElectrical stimulation for 60 minutes | Device | MC5-A Scramble instrument |
Primary outcome
Change in Pain Score
Time frame: 15 days
Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15. Scale is 0 (none) to 10 (severe)
3 secondary outcomes
Effect of MC5-A on Pain and Neuropathy
Time frame: 2 weeks
Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy
Time frame: 2 weeks
Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas J. Smith, MD principal investigator
Massey Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing questionnaire administration, Sensory Neuropathy Scale instrument and Quality of Life instrument in people with Chemotherapeutic Agent Toxicity and Neurotoxicity, run by Virginia Commonwealth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 22 Mar 2013). 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 Pain Score (time frame: 15 days). 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 29 Mar 2017.