PainNCT01347723
Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy
An observational study of Pain and Peripheral Neuropathy, run by Mayo Clinic at 1 site in United States.
Trial summary
This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from 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, questionnaire administration and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2015
- Phase
- Observational
- 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
- Pain or symptoms of neuropathy or pain of >= 1 month (30 days) duration for which the patient wants intervention
- Participants have to relate that tingling or pain 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 and expected to have tingling or pain of at least 4/10 at the time of the first treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
- Life expectancy >= 3 months (90 days)
- Case review by the study chair, or designate, as a case where treatment should be tried.
- Ability to complete questionnaire(s) by themselves or with assistance - Ability to provide informed written consent
Who cannot join
- Pregnant women
- 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 for seizure prevention, concurrently using ketamine, symptomatic brain metastases; Note: anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable dose
- 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
- Currently on gabapentin or pregabalin Note: (because of data that support that patients don't do as well when on gabapentin or pregabalin, all patients on these medications will be weaned off of them prior to study initiation. The study team will provide instructions on how to do this).
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 Open Access Trial
This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy
Read the detailed description
OBJECTIVES:
- To record the types of patients that we treat, along with the reported efficacy and potential toxicity associated with scrambler therapy.
II. To get experience with patient reported outcome measurement tools that we use in this trial, including a report of analgesic use.
OUTLINE: Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up for 10 weeks.
III. To explore neurologic testing changes in patients receiving scrambler therapy.
- Conditions
- Pain, Peripheral Neuropathy
- Being tested
- scrambler therapy, questionnaire administration, management of therapy complications
- 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
Undergo scrambler therapy
questionnaire administrationOther
Ancillary studies
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Undergo scrambler therapy
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (pain therapy) | Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity. Receives: Other: scrambler therapy; Other: questionnaire administration; Procedure: management of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain on a 0-10 numerical rating scale.
Measured: 3 years
Secondary outcomes (1)
Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork.
Patients will also undergo neurologic function testing. This will be done in an exploratory measure to try to correlate changes in the patient reported outcome instrument data with changes in the different measures of neurologic function. The two measures will be Neurometer Current Perception Threshold (CPT) Testing and testing with a Rydel-Seiffer graduated tuning fork.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Loprinzi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347723
- Sponsor's protocol ID
- MC10CC
- Other IDs
- NCI-2011-00339, MC10CC, 11-000675, NCI-2011-00339
- Status last verified
- Jan 2016
- First submitted
- 30 Mar 2011
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. 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 Open Access Trial
- ClinicalTrials.gov ID
- NCT01347723
- Acronym / sponsor ID
- MC10CC
- Conditions
- Pain, Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 May 2011 (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.
This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy
Detailed description
OBJECTIVES:
- To record the types of patients that we treat, along with the reported efficacy and potential toxicity associated with scrambler therapy.
II. To get experience with patient reported outcome measurement tools that we use in this trial, including a report of analgesic use.
OUTLINE: Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up for 10 weeks.
III. To explore neurologic testing changes in patients receiving scrambler therapy.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (pain therapy) | – | Other: scrambler therapy, Other: questionnaire administration, Procedure: management of therapy complicationsPatients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pain or symptoms of neuropathy or pain of >= 1 month (30 days) duration for which the patient wants intervention
- Participants have to relate that tingling or pain 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 and expected to have tingling or pain of at least 4/10 at the time of the first treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
- Life expectancy >= 3 months (90 days)
- Case review by the study chair, or designate, as a case where treatment should be tried.
Key exclusion criteria (8 listed)
- Pregnant women
- 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 for seizure prevention, concurrently using ketamine, symptomatic brain metastases; Note: anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable dose
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 therapyUndergo scrambler therapy | Other | Supportive care (pain therapy) |
| questionnaire administrationAncillary studies | Other | Supportive care (pain therapy) |
| management of therapy complicationsAlso: complications of therapy, management ofUndergo scrambler therapy | Procedure or surgery | Supportive care (pain therapy) |
Primary outcome
Change in pain on a 0-10 numerical rating scale.
Time frame: 3 years
1 secondary outcome
Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork.
Time frame: 3 years
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 14 May 2020.
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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 principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 6 inclusion and 8 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 14 May 2020. 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.
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.
What does the primary outcome measure?
Change in pain on a 0-10 numerical rating scale. (time frame: 3 years). 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 14 May 2020.