PainPhase 2NCT01290224
MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy
A Phase 2 study testing scrambler therapy and questionnaire administration in people with Pain and Peripheral Neuropathy, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy. 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 years and older
- Conditions the study is for
- Pain, Peripheral Neuropathy
- What is being tested?
- scrambler therapy and questionnaire administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2011
- 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
- Received neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezomib); Note: this neurotoxic chemotherapy must have been completed more than 3 months prior to when they enter this trial
- Pain or symptoms of peripheral neuropathy in the feet of >= 1 month (30 days) duration attributed to chemotherapy-induced peripheral neuropathy, for which the patient wants intervention
- Participants have to relate that numbness, tingling or pain in their toes/feet was at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
- Life expectancy >= 3 months (90 days)
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide informed written consent
- No change in scheduled analgesic agents for at least one week
Who cannot join
- Pregnant women
- CIPN troubles in the lower extremities more proximal to the mid calf
- Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
- Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices)
- Patients with a history of myocardial infarction or ischemic heart disease within the past six months
- Patients with history of epilepsy, brain damage, use of anti-convulsants, symptomatic brain metastases
Show all 10Show fewer
- Other identified causes of painful lower extremity paresthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: B12 deficiency, Acquired Immunodeficiency Syndrome [AIDS], monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.)
- Skin conditions such as open sores that would prevent proper application of the electrodes
- Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
- Prior treatment with Calmare MC-5A therapy for any reason or knowledge of application procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial
RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy.
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
PRIMARY OBJECTIVES:
- To explore the feasibility of studying scrambler therapy versus a sham procedure for the alleviation of lower extremity chemotherapy induced peripheral neuropathy (CIPN).
SECONDARY OBJECTIVES:
- To obtain prospective pilot experience with recommended scrambler therapy, with regards to treatment efficacy to determine effect size estimates, patient related outcome measurement tools that we use in this trial, tolerability, and analgesic use.
OUTLINE: Patients undergo a sham procedure on the back or scrambler therapy on both lower extremities for up to 30 minutes with the Calmare MC5-A device and cutaneous electrode patches applied above and below the area of pain on days 1 and 2. Patients continue scrambler therapy for 10 days in the absence of unacceptable toxicity.
- Conditions
- Pain, Peripheral Neuropathy
- Being tested
- scrambler therapy, sham intervention, questionnaire administration
- Medical subject headings
- Pain, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scrambler therapyOther
Also called TENPS, transcutaneous electromanipulation by nervous patterns scrambler therapy
Undergo MC5-A therapy
sham interventionProcedure or surgery
Undergo sham procedure
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care | Experimental | See Detailed Description Receives: Other: scrambler therapy; Procedure: sham intervention; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire
CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.
Measured: On days 1 and 2
Secondary outcomes (6)
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question
The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated.
Measured: On days 1 and 2
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire
The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H).
Measured: Day 1 and Day 10
Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question
The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week.
Measured: Week 1 and Week 10
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions
The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported.
Measured: Day 1 and Week 10
Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
Measured: Day 1 to Day 10
Analgesic Use Over Time
Measured: On days 1-11 and for 10 weeks after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionJun 2011
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 PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Loprinzi, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290224
- Sponsor's protocol ID
- MC10C8
- Other IDs
- NCI-2011-00109, 10-007874, MC10C8
- Status last verified
- Jan 2014
- First submitted
- 1 Feb 2011
- Last updated
- 5 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial
- ClinicalTrials.gov ID
- NCT01290224
- Acronym / sponsor ID
- MC10C8
- Conditions
- Pain, Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Posted 5 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy.
PURPOSE: This phase II trial is studying how well MC5-A scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy
Detailed description
PRIMARY OBJECTIVES:
- To explore the feasibility of studying scrambler therapy versus a sham procedure for the alleviation of lower extremity chemotherapy induced peripheral neuropathy (CIPN).
SECONDARY OBJECTIVES:
- To obtain prospective pilot experience with recommended scrambler therapy, with regards to treatment efficacy to determine effect size estimates, patient related outcome measurement tools that we use in this trial, tolerability, and analgesic use.
OUTLINE: Patients undergo a sham procedure on the back or scrambler therapy on both lower extremities for up to 30 minutes with the Calmare MC5-A device and cutaneous electrode patches applied above and below the area of pain on days 1 and 2. Patients continue scrambler therapy for 10 days in the absence of unacceptable toxicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care | Experimental | Other: scrambler therapy, Procedure: sham intervention, Other: questionnaire administrationSee Detailed Description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Received neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezomib); Note: this neurotoxic chemotherapy must have been completed more than 3 months prior to when they enter this trial
- Pain or symptoms of peripheral neuropathy in the feet of >= 1 month (30 days) duration attributed to chemotherapy-induced peripheral neuropathy, for which the patient wants intervention
- Participants have to relate that numbness, tingling or pain in their toes/feet was at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
- Life expectancy >= 3 months (90 days)
Key exclusion criteria (10 listed)
- Pregnant women
- CIPN troubles in the lower extremities more proximal to the mid calf
- Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
- Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices)
- Patients with a history of myocardial infarction or ischemic heart disease within the past six months
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 |
|---|---|---|
| scrambler therapyAlso: TENPS, transcutaneous electromanipulation by nervous patterns scrambler therapyUndergo MC5-A therapy | Other | Supportive Care |
| sham interventionUndergo sham procedure | Procedure or surgery | Supportive Care |
| questionnaire administrationAncillary studies | Other | Supportive Care |
Primary outcome
Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire
Time frame: On days 1 and 2
CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.
6 secondary outcomes
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question
Time frame: On days 1 and 2
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire
Time frame: Day 1 and Day 10
Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question
Time frame: Week 1 and Week 10
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions
Time frame: Day 1 and Week 10
Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time frame: Day 1 to Day 10
Analgesic Use Over Time
Time frame: On days 1-11 and for 10 weeks after therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- 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.
Charles Loprinzi, M.D. study chair
Mayo Clinic
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 scrambler therapy and questionnaire administration in people with Pain and Peripheral Neuropathy, run by Mayo Clinic 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 8 inclusion and 10 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 5 Mar 2014. 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. 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 5 Mar 2014). 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?
Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire (time frame: On days 1 and 2). 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 5 Mar 2014.