rTMS in Improving Neuropathy in Patients With Stage I-IV Cancer Who Have Received Oxaliplatin Chemotherapy
Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat Oxaliplatin-Induced Neuropathy
2 other identifiers
interventional
56
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2017
CompletedFirst Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
October 14, 2025
October 1, 2025
9.8 years
July 11, 2017
October 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in perceptions of chemotherapy-induced peripheral neuropathy (CIPN)
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. The 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'.
Baseline up to 1 month
Secondary Outcomes (5)
Change in cortical activity
Baseline up to 1 month
Change in perception of improvement in CIPN as assessed by Patients' Global Impression of Change (PGIC) questionnaire
Baseline up to 1 month
Change in perception of improvement in CIPN as assessed by Edmonton Symptom Assessment System (ESAS) questionnaire
Baseline up to 1 month
Change in perception of improvement in CIPN as assessed by Brief Pain Inventory-short form (BPI) questionnaire
Baseline up to 1 month
Change in perception of improvement in CIPN as assessed by Pain Vigilance and Awareness Questionnaire (PVAQ)
Baseline up to 1 month
Study Arms (3)
Group I (rTMS)
EXPERIMENTALPatients undergo rTMS over 30 minutes for 10 sessions over 10 business days.
Group II (sham rTMS)
SHAM COMPARATORPatients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.
Group III (standard of care)
ACTIVE COMPARATORPatients receive standard of care.
Interventions
Receive standard of care
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- Patients with stage I-IV cancers who received oxaliplatin chemotherapy
- Understand and read English, sign a written informed consent, and be willing to follow protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Grade 2 or higher neuropathic symptoms according to the National Cancer Institute's 4 point grading scale
- Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician)
- Patients must have neuropathic symptoms for a minimum of 3 months
- No plans to change the type of pain medication (if a patient is on pain medication)
- Willing to come to MD Anderson for the therapy sessions
You may not qualify if:
- Patients who are taking any antipsychotic medications
- 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
- Patients who have ever been diagnosed with bipolar disorder or schizophrenia
- Patients who have a history of head injury, focal brain lesions, or known seizure activity
- Patients who are withdrawing from drugs
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Prinsloo
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 17, 2017
Study Start
July 10, 2017
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
October 14, 2025
Record last verified: 2025-10