Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-06 @ 6:14 PM
Study NCT ID:
NCT03219502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
rTMS in Improving Neuropathy in Patients With Stage I-IV Cancer Who Have Received Oxaliplatin Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2017-07-11', 'studyFirstSubmitQcDate': '2017-07-13', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in perceptions of chemotherapy-induced peripheral neuropathy (CIPN)', 'timeFrame': 'Baseline up to 1 month', 'description': "Differences between repetitive transcranial magnetic stimulation (rTMS) and placebo (PC) and between rTMS and wait-list control (WLC) will be assessed by Pain Quality Assessment Scale (PQAS). Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.\n\nThe Pain Quality Assessment Scale (PQAS) is a 20-item measure developed to quantify quality and intensity of neuropathic pain. It was derived from the Neuropathic Pain Scale and includes symptom descriptors common to people with neuropathic symptoms.\\[44\\] Our primary outcome will be the 'unpleasantness subscale'."}], 'secondaryOutcomes': [{'measure': 'Change in cortical activity', 'timeFrame': 'Baseline up to 1 month', 'description': 'Will include pre, interim, and post comparisons of the electroencephalography (EEG), via low resolution electromagnetic tomography (LORETA) imaging software, on an individual basis. These analyses will include global differences in cortical activation as well as site-specific dominant frequencies for each patient.'}, {'measure': "Change in perception of improvement in CIPN as assessed by Patients' Global Impression of Change (PGIC) questionnaire", 'timeFrame': 'Baseline up to 1 month', 'description': 'Will use data across the set of post-intervention assessment points. Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.\n\nThe Patients\' Global Impression of Change (PGIC) will measure clinically important change from the patient\'s perspective. Patients report symptoms on a range from "very much worse" to "very much improved".'}, {'measure': 'Change in perception of improvement in CIPN as assessed by Edmonton Symptom Assessment System (ESAS) questionnaire', 'timeFrame': 'Baseline up to 1 month', 'description': 'Will use data across the set of post-intervention assessment points. Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.\n\nThe Edmonton Symptom Assessment System (ESAS) is a validated tool to assess 12 major symptoms (rated 0-10) that are common in cancer patients during the 24 hours preceding its administration. The symptoms assessed are pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, insomnia, well-being, financial distress, and spiritual distress.'}, {'measure': 'Change in perception of improvement in CIPN as assessed by Brief Pain Inventory-short form (BPI) questionnaire', 'timeFrame': 'Baseline up to 1 month', 'description': "Will use data across the set of post-intervention assessment points. Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.\n\nThe Brief Pain Inventory-short form (BPI) is a validated, widely used, questionnaire that will assess severity and impact of pain. We will prioritize assessment of the 'worst pain' subscale, and 'interference' subscale as they have been used to assess pain in other pain trials."}, {'measure': 'Change in perception of improvement in CIPN as assessed by Pain Vigilance and Awareness Questionnaire (PVAQ)', 'timeFrame': 'Baseline up to 1 month', 'description': 'Will use data across the set of post-intervention assessment points. Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.\n\nThe Pain Vigilance and Awareness Questionnaire (PVAQ) will assess attention to pain in terms of awareness, consciousness, vigilance, and observation of pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Neoplasm', 'Neuropathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how well repetitive transcranial magnetic stimulation (rTMS) works in improving neuropathy due to oxaliplatin chemotherapy in patients with stage I-IV cancer. rTMS is designed to change brain activity by introducing small magnetic impulses to the scalp that encourage the brain to change its activity.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Examine the effects of the repetitive transcranial magnetic stimulation (rTMS) training program on perceptions of chemotherapy-induced peripheral neuropathy (CIPN) versus placebo (PC) and wait-list control groups (WLC).\n\nSECONDARY OBJECTIVES:\n\nI. Explore changes in cortical activity: Electroencephalography (EEG) brain maps (low resolution electromagnetic tomography) will be assessed over time and compared between groups.\n\nII. Determine if rTMS improves other aspects of CIPN, quality of life (QOL), and mental health (MH) compared to PC and WLC.\n\nIII. Explore moderators/mediators of the intervention by examining the extent to which changes in EEG patterns mediate the effects of the intervention and the extent to which there are interaction effects of the intervention and each of the baseline brain regions.\n\nOUTLINE: Patients are randomized to 1 of 3 groups.\n\nGROUP I: Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.\n\nGROUP II: Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.\n\nGROUP III: Patients receive standard of care.\n\nAfter completion of study, patients are followed up within 1 week and at 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with stage I-IV cancers who received oxaliplatin chemotherapy\n* Understand and read English, sign a written informed consent, and be willing to follow protocol requirements\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2\n* Grade 2 or higher neuropathic symptoms according to the National Cancer Institute's 4 point grading scale\n* Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician)\n* Patients must have neuropathic symptoms for a minimum of 3 months\n* No plans to change the type of pain medication (if a patient is on pain medication)\n* Willing to come to MD Anderson for the therapy sessions\n\nExclusion Criteria:\n\n* Patients who are taking any antipsychotic medications\n* Patients who have evidence of brain metastases or any with any active central nervous system (CNS) disease at their time of entry into the trial\n* Patients who have ever been diagnosed with bipolar disorder or schizophrenia\n* Patients who have a history of head injury, focal brain lesions, or known seizure activity\n* Patients who are withdrawing from drugs\n* Patients with intracranial implants or a cardiac pacemaker or any device that is not considered magnetic resonance imaging (MRI) safe. Colorectal patients are sometimes prescribed Tramadol to help control the symptoms of CIPN. Tramadol does lower the seizure threshold, however these patients will be considered eligible for the study if they discontinue the drug 48 hours before the baseline and do not use it during the duration of the study"}, 'identificationModule': {'nctId': 'NCT03219502', 'briefTitle': 'rTMS in Improving Neuropathy in Patients With Stage I-IV Cancer Who Have Received Oxaliplatin Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat Oxaliplatin-Induced Neuropathy', 'orgStudyIdInfo': {'id': '2016-1134'}, 'secondaryIdInfos': [{'id': 'NCI-2018-02093', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2016-1134', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (rTMS)', 'description': 'Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Repetitive Transcranial Magnetic Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group II (sham rTMS)', 'description': 'Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Sham Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III (standard of care)', 'description': 'Patients receive standard of care.', 'interventionNames': ['Other: Best Practice', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive standard of care', 'armGroupLabels': ['Group III (standard of care)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (rTMS)', 'Group II (sham rTMS)', 'Group III (standard of care)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (rTMS)', 'Group II (sham rTMS)', 'Group III (standard of care)']}, {'name': 'Repetitive Transcranial Magnetic Stimulation', 'type': 'PROCEDURE', 'otherNames': ['rTMS'], 'description': 'Undergo rTMS', 'armGroupLabels': ['Group I (rTMS)']}, {'name': 'Sham Intervention', 'type': 'PROCEDURE', 'description': 'Undergo sham rTMS', 'armGroupLabels': ['Group II (sham rTMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sarah Prinsloo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}