CIPN - Chemotherapy-Induced Peripheral NeuropathyPhase 2NCT06914557
Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.
A Phase 2 study testing Scrambler Therapy and Questionnaire and Physical Exam in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Pain, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, Pain
- What is being tested?
- Scrambler Therapy and Questionnaire and Physical Exam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Persons aged 18 years or older with cancer
- Eastern Cooperative Oncology Group 0-2
- At least a 4/10 average pain score prior to treatment
- At least CTCAE version 5.0 grade 2 neuropathies.
- Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy.
- Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire
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- Patients must have discontinued neurotoxic chemotherapy within the last 3 months with no additional therapy planned for the next 6 months after initiation of CIPN treatment.
- Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation
- Patients must be able to provide informed written consent.
Who cannot join
- Children or adolescents
- Pregnant or nursing patients
- Presence of an implantable life supporting medical device or implantable drug delivery system
- Patients with severe skin conditions preventing the proper application of electrodes
- Patients currently on monoamine oxidase inhibitors MAOIs.
- Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin).
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- Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy)
- Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed
- Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder
- Patients with uncontrolled epilepsy.
- Patients who have previously attempted or undergone Scrambler therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19123
Marcin Chwistek, MD, 215-728-3544, marcin.chwistek@fccc.edu
Leslie Fortin, MPH, 215-214-3996, leslie.fortin@fccc.edu
About this study
Official title: Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy: A Randomized Phase II Pilot Trial.
The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy results in improved levels of function as measured with the PDQ, and a decreased need for opioid medications.
Our primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in achieving at least a 50% reduction in pain scores, when comparing the cross-sectionally measured "average" pain score at day 35 to the cross-sectionally measured "average" pain score at baseline.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequently experienced and often persistent side effect of many commonly utilized chemotherapy regimens. This list of agents includes platinum agents, taxanes, vinca alkaloids, and bortezomib. The estimated incidence of this toxicity, according to some sources, can be as high as 68.1% (95% CI: 57.7-78.4%) among patients with exposure to antineoplastic agents commonly known to cause neuropathy. Chemotherapy-induced peripheral neuropathy can be significant for many patients and can limit their ability to perform activities of daily living (ADLs). It is a frequent dose-limiting complication around which many oncologists must navigate.
While many agents have been studied to mitigate this complication, few have been shown to be effective or clinically significant. Duloxetine, perhaps the agent with the most evidence for use, showed a mean decrease in a patient's average pain score on the Brief Pain Inventory-Short Form (BPI-SF) of 1.06 versus 0.34 in the control arm (on an 11-point scale) (p = 0.003). Many other therapies have been proposed, such as gabapentin, tricyclic antidepressants (TCAs), cannabinoids, lidocaine, oral glutamine, cryotherapy, acupuncture, massage, and exercise-each with varying degrees of effectiveness. Despite these numerous therapies, duloxetine is the current standard of care for treating neuropathic pain, as evidenced by its inclusion in the National Comprehensive Cancer Network guidelines for the management of adult cancer pain.
Scrambler therapy is a novel treatment modality that has a growing body of evidence for neuropathic pain. It was originally developed by investigators at the University of Rome Tor Vergata following a series of preliminary clinical trials conducted from 1999 to 2006, involving 2,297 cases of various types of medication-resistant neuropathic pain. The machine uses five artificial neurons to transmit strings of "non-pain" signals based on a proprietary algorithm.
The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy will result in improved levels of function as measured with the PDQ, and decreased need for opioid medications.
Our primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in helping patients achieve at least a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score (question 5 on the BPI) at day 35 to the score at baseline (day 1). The post-crossover outcomes will be included in the primary analysis. The first measurement on day 1 and the last measurement on day 35 will be used.
Secondary objectives:
Investigate the proportion of patients in each arm who achieve at least a 30% reduction in their cross-sectionally measured "average" pain score on the BPI from day 1 to day 35 and from day 1 to day 56.
Investigate the effectiveness of Scrambler therapy in groups stratified by receipt of neurotoxic cancer therapeutic agents prior to study enrollment, based on changes in "average pain score" on the BPI from day 1 to day 35 and day 1 to day 56.
Compare the change in average daily oral morphine requirements (i.e., dosage) by treatment arm from day 1 to day 35 and day 1 to day 56.
Investigate the proportion of patients in each arm who achieve at least a 50% improvement in PDQ score from day 1 to day 35 and day 1 to day 56.
Exploratory outcomes:
Examine whether the proportion of patients who achieve at least a 50% reduction in their pain scores at the end of day 35 after receiving both Scrambler therapy and duloxetine differs between those randomized to the Scrambler therapy arm versus those in the duloxetine-based usual care arm who decide to cross over to the Scrambler therapy arm.
Investigate the proportion of patients between arms with at least a 50% improvement in EORTC score from day 1 to day 35 and day 1 to day 56.
Investigate the percentage of patients in the Scrambler arm who maintain at least a 50% improvement in EORTC score at day 180.
- Being tested
- Scrambler Therapy, Questionnaire and Physical Exam
- Keywords
- CIPN, neuropathy, Chemotherapy-Induced Peripheral Neuropathy, Duloxetine, Scrambler Therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scrambler TherapyDevice
Also called Scrambler device therapy
Scrambler therapy will be administered by the staff of the Supportive Oncology and Palliative Care team who have been trained in Scrambler therapy and have extensive experience providing it to patients with neuropathic cancer-related pain. Patients who meet the study criteria will be treated daily, Monday through Friday, for up to 10 sessions. The treatment may be terminated sooner if a patient experiences complete pain relief or if it is ineffective after five sessions. Patients will be closely monitored during the treatment. The treatment is non-painful and not associated with any significant adverse effects.
Questionnaire and Physical ExamOther
Also called EORTC QLQ-CIPN20, PDQ
15-minute-long questionnaires evaluating Pain and degree of pain.
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine Group | Other | Patients will be treated with Duloxetine as per Specialized Outpatient Palliative Care SOPC standard neuropathy treatment protocol Receives: Other: Questionnaire and Physical Exam |
| Scrambler + Duloxetine | Active comparator | Patients' pharmacological treatment of their CIPN (including the management of duloxetine and other co-analgesics) will follow SOPC standard neuropathy treatment protocol Receives: Device: Scrambler Therapy; Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the proportion with a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score at day 35 with the cross-sectionally measured "average" pain score at baseline (baseline = day 1).
Investigate whether Scrambler therapy with duloxetine is superior to duloxetine alone in patient achievement of at least a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score at day 35 to the cross-sectionally measured "average" pain score at baseline (baseline = day 1).
Measured: At Day 35
Secondary outcomes (1)
Proportion of patients achieving ≥30% reduction in average pain score on BPI from baseline to day 35 and day 56: secondary analysis including wait-list control post-crossover outcomes.
Investigate the proportion of patients between arms who achieve at least 30% reduction in their cross-sectionally measured "average" pain score on the BPI from baseline (day 1) to day 35 and from day 1 to day 56. The wait-list control outcomes post-crossover will be included in this secondary analysis.
Measured: At Day 35 & Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start3 Mar 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators propose a randomized wait-list control study comparing the effectiveness of Scrambler therapy with duloxetine to duloxetine-based usual care, which is the current standard for CIPN treatment. Wait-list control studies allow the control group to cross over to the intervention arm after the control period. These studies are commonly used in behavioral trials to ensure all participants have access to a potentially beneficial intervention. Wait-list control designs may also enhance accrual if the intervention is perceived as desirable by participants.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Chwistek, MD, Fox Chase Cancer Center
- Investigators
- Marcin Chwistek, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914557
- Sponsor's protocol ID
- 23-1043
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We are not planning on sharing individual participant data IPD with anyone else. We will publish the data once available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy: A Randomized Phase II Pilot Trial.
- ClinicalTrials.gov ID
- NCT06914557
- Acronym / sponsor ID
- 23-1043
- Keywords
- CIPN, neuropathy, Chemotherapy-Induced Peripheral Neuropathy, Duloxetine, Scrambler Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Apr 2025 (actual)
- 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.
The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy results in improved levels of function as measured with the PDQ, and a decreased need for opioid medications.
Our primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in achieving at least a 50% reduction in pain scores, when comparing the cross-sectionally measured "average" pain score at day 35 to the cross-sectionally measured "average" pain score at baseline.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequently experienced and often persistent side effect of many commonly utilized chemotherapy regimens. This list of agents includes platinum agents, taxanes, vinca alkaloids, and bortezomib. The estimated incidence of this toxicity, according to some sources, can be as high as 68.1% (95% CI: 57.7-78.4%) among patients with exposure to antineoplastic agents commonly known to cause neuropathy. Chemotherapy-induced peripheral neuropathy can be significant for many patients and can limit their ability to perform activities of daily living (ADLs). It is a frequent dose-limiting complication around which many oncologists must navigate.
While many agents have been studied to mitigate this complication, few have been shown to be effective or clinically significant. Duloxetine, perhaps the agent with the most evidence for use, showed a mean decrease in a patient's average pain score on the Brief Pain Inventory-Short Form (BPI-SF) of 1.06 versus 0.34 in the control arm (on an 11-point scale) (p = 0.003). Many other therapies have been proposed, such as gabapentin, tricyclic antidepressants (TCAs), cannabinoids, lidocaine, oral glutamine, cryotherapy, acupuncture, massage, and exercise-each with varying degrees of effectiveness. Despite these numerous therapies, duloxetine is the current standard of care for treating neuropathic pain, as evidenced by its inclusion in the National Comprehensive Cancer Network guidelines for the management of adult cancer pain.
Scrambler therapy is a novel treatment modality that has a growing body of evidence for neuropathic pain. It was originally developed by investigators at the University of Rome Tor Vergata following a series of preliminary clinical trials conducted from 1999 to 2006, involving 2,297 cases of various types of medication-resistant neuropathic pain. The machine uses five artificial neurons to transmit strings of "non-pain" signals based on a proprietary algorithm.
The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy will result in improved levels of function as measured with the PDQ, and decreased need for opioid medications.
Our primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in helping patients achieve at least a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score (question 5 on the BPI) at day 35 to the score at baseline (day 1). The post-crossover outcomes will be included in the primary analysis. The first measurement on day 1 and the last measurement on day 35 will be used.
Secondary objectives:
Investigate the proportion of patients in each arm who achieve at least a 30% reduction in their cross-sectionally measured "average" pain score on the BPI from day 1 to day 35 and from day 1 to day 56.
Investigate the effectiveness of Scrambler therapy in groups stratified by receipt of neurotoxic cancer therapeutic agents prior to study enrollment, based on changes in "average pain score" on the BPI from day 1 to day 35 and day 1 to day 56.
Compare the change in average daily oral morphine requirements (i.e., dosage) by treatment arm from day 1 to day 35 and day 1 to day 56.
Investigate the proportion of patients in each arm who achieve at least a 50% improvement in PDQ score from day 1 to day 35 and day 1 to day 56.
Exploratory outcomes:
Examine whether the proportion of patients who achieve at least a 50% reduction in their pain scores at the end of day 35 after receiving both Scrambler therapy and duloxetine differs between those randomized to the Scrambler therapy arm versus those in the duloxetine-based usual care arm who decide to cross over to the Scrambler therapy arm.
Investigate the proportion of patients between arms with at least a 50% improvement in EORTC score from day 1 to day 35 and day 1 to day 56.
Investigate the percentage of patients in the Scrambler arm who maintain at least a 50% improvement in EORTC score at day 180.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators propose a randomized wait-list control study comparing the effectiveness of Scrambler therapy with duloxetine to duloxetine-based usual care, which is the current standard for CIPN treatment. Wait-list control studies allow the control group to cross over to the intervention arm after the control period. These studies are commonly used in behavioral trials to ensure all participants have access to a potentially beneficial intervention. Wait-list control designs may also enhance accrual if the intervention is perceived as desirable by participants.
| Arm | Type | Receives |
|---|---|---|
| Duloxetine Group | Other | Other: Questionnaire and Physical ExamPatients will be treated with Duloxetine as per Specialized Outpatient Palliative Care SOPC standard neuropathy treatment protocol |
| Scrambler + Duloxetine | Active comparator | Device: Scrambler Therapy, Other: Questionnaire and Physical ExamPatients' pharmacological treatment of their CIPN (including the management of duloxetine and other co-analgesics) will follow SOPC standard neuropathy treatment protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Persons aged 18 years or older with cancer
- Eastern Cooperative Oncology Group 0-2
- At least a 4/10 average pain score prior to treatment
- At least CTCAE version 5.0 grade 2 neuropathies.
- Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy.
Key exclusion criteria (11 listed)
- Children or adolescents
- Pregnant or nursing patients
- Presence of an implantable life supporting medical device or implantable drug delivery system
- Patients with severe skin conditions preventing the proper application of electrodes
- Patients currently on monoamine oxidase inhibitors MAOIs.
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: Scrambler device therapyScrambler therapy will be administered by the staff of the Supportive Oncology and Palliative Care team who have been trained in Scrambler therapy and have extensive experience providing it to patients with neuropathic cancer-related pain. Patients who meet the study criteria will be treated daily, Monday through Friday, for up to 10 sessions. The treatment may be terminated sooner if a patient experiences complete pain relief or if it is ineffective after five sessions. Patients will be closely monitored during the treatment. The treatment is non-painful and not associated with any significant adverse effects. | Device | Scrambler + Duloxetine |
| Questionnaire and Physical ExamAlso: EORTC QLQ-CIPN20, PDQ15-minute-long questionnaires evaluating Pain and degree of pain. | Other | Duloxetine Group, Scrambler + Duloxetine |
Primary outcome
The difference in the proportion with a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score at day 35 with the cross-sectionally measured "average" pain score at baseline (baseline = day 1).
Time frame: At Day 35
Investigate whether Scrambler therapy with duloxetine is superior to duloxetine alone in patient achievement of at least a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score at day 35 to the cross-sectionally measured "average" pain score at baseline (baseline = day 1).
1 secondary outcome
Proportion of patients achieving ≥30% reduction in average pain score on BPI from baseline to day 35 and day 56: secondary analysis including wait-list control post-crossover outcomes.
Time frame: At Day 35 & Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No. We are not planning on sharing individual participant data IPD with anyone else. We will publish the data once available.
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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.
Marcin Chwistek, MD principal investigator
Fox Chase Cancer Center
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 and Physical Exam in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Pain, run by Fox Chase Cancer Center 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 11 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerald Nkogbu, MBBS, MS (2157285378, gerald.nkogbu@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the proportion with a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score at day 35 with the cross-sectionally measured "average" pain score at baseline (baseline = day 1). (time frame: At Day 35). 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 9 Apr 2025.