Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-02 @ 3:55 AM
Study NCT ID:
NCT06914557
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'timeFrame': 'At Day 35', 'description': '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).'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'At Day 35 & Day 56', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CIPN', 'neuropathy', 'Chemotherapy-Induced Peripheral Neuropathy', 'Duloxetine', 'Scrambler Therapy'], 'conditions': ['CIPN - Chemotherapy-Induced Peripheral Neuropathy', 'Pain']}, 'descriptionModule': {'briefSummary': '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.\n\nOur 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.', 'detailedDescription': '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.\n\nWhile 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.\n\nScrambler 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.\n\nThe 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.\n\nOur 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.\n\nSecondary objectives:\n\nInvestigate 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.\n\nInvestigate 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.\n\nCompare 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.\n\nInvestigate 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.\n\nExploratory outcomes:\n\nExamine 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.\n\nInvestigate 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.\n\nInvestigate the percentage of patients in the Scrambler arm who maintain at least a 50% improvement in EORTC score at day 180.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Persons aged 18 years or older with cancer\n2. Eastern Cooperative Oncology Group 0-2\n3. At least a 4/10 average pain score prior to treatment\n4. At least CTCAE version 5.0 grade 2 neuropathies.\n5. Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy.\n6. Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire\n7. 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.\n8. Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation\n9. Patients must be able to provide informed written consent.\n\nExclusion Criteria:\n\n1. Children or adolescents\n2. Pregnant or nursing patients\n3. Presence of an implantable life supporting medical device or implantable drug delivery system\n4. Patients with severe skin conditions preventing the proper application of electrodes\n5. Patients currently on monoamine oxidase inhibitors MAOIs.\n6. Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin).\n7. Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy)\n8. Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed\n9. Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder\n10. Patients with uncontrolled epilepsy.\n11. Patients who have previously attempted or undergone Scrambler therapy.'}, 'identificationModule': {'nctId': 'NCT06914557', 'briefTitle': 'Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.', 'organization': {'class': 'OTHER', 'fullName': 'Fox Chase Cancer Center'}, 'officialTitle': 'Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy: A Randomized Phase II Pilot Trial.', 'orgStudyIdInfo': {'id': '23-1043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Duloxetine Group', 'description': 'Patients will be treated with Duloxetine as per Specialized Outpatient Palliative Care SOPC standard neuropathy treatment protocol', 'interventionNames': ['Other: Questionnaire and Physical Exam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Scrambler + Duloxetine', 'description': "Patients' pharmacological treatment of their CIPN (including the management of duloxetine and other co-analgesics) will follow SOPC standard neuropathy treatment protocol", 'interventionNames': ['Device: Scrambler Therapy', 'Other: Questionnaire and Physical Exam']}], 'interventions': [{'name': 'Scrambler Therapy', 'type': 'DEVICE', 'otherNames': ['Scrambler device therapy'], 'description': '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.', 'armGroupLabels': ['Scrambler + Duloxetine']}, {'name': 'Questionnaire and Physical Exam', 'type': 'OTHER', 'otherNames': ['EORTC QLQ-CIPN20', 'PDQ'], 'description': '15-minute-long questionnaires evaluating Pain and degree of pain.', 'armGroupLabels': ['Duloxetine Group', 'Scrambler + Duloxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19123', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marcin Chwistek, MD', 'role': 'CONTACT', 'email': 'marcin.chwistek@fccc.edu', 'phone': '215-728-3544'}, {'name': 'Leslie Fortin, MPH', 'role': 'CONTACT', 'email': 'leslie.fortin@fccc.edu', 'phone': '215-214-3996'}, {'name': 'Marcin Chwistek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dylan Sherry, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Leigh Kinczewski, CRNP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Gerald Nkogbu, MBBS, MS', 'role': 'CONTACT', 'email': 'gerald.nkogbu@fccc.edu', 'phone': '2157285378'}, {'name': 'Leslie Fortin, MPH', 'role': 'CONTACT', 'email': 'leslie.fortin@fccc.edu', 'phone': '215-214-3996'}], 'overallOfficials': [{'name': 'Marcin Chwistek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We are not planning on sharing individual participant data IPD with anyone else. We will publish the data once available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fox Chase Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR/MD', 'investigatorFullName': 'Marcin Chwistek, MD', 'investigatorAffiliation': 'Fox Chase Cancer Center'}}}}