- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03219502
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
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. 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).
SECONDARY OBJECTIVES:
I. Explore changes in cortical activity: Electroencephalography (EEG) brain maps (low resolution electromagnetic tomography) will be assessed over time and compared between groups.
II. Determine if rTMS improves other aspects of CIPN, quality of life (QOL), and mental health (MH) compared to PC and WLC.
III. 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.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.
GROUP II: Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.
GROUP III: Patients receive standard of care.
After completion of study, patients are followed up within 1 week and at 1 month.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (rTMS)
Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo rTMS
Other Names:
|
Sham Comparator: Group II (sham rTMS)
Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo sham rTMS
|
Active Comparator: Group III (standard of care)
Patients receive standard of care.
|
Ancillary studies
Other Names:
Ancillary studies
Receive standard of care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perceptions of chemotherapy-induced peripheral neuropathy (CIPN)
Time Frame: Baseline up to 1 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cortical activity
Time Frame: Baseline up to 1 month
|
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.
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Baseline up to 1 month
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Change in perception of improvement in CIPN as assessed by Patients' Global Impression of Change (PGIC) questionnaire
Time Frame: Baseline up to 1 month
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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. The 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". |
Baseline up to 1 month
|
Change in perception of improvement in CIPN as assessed by Edmonton Symptom Assessment System (ESAS) questionnaire
Time Frame: Baseline up to 1 month
|
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. The 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. |
Baseline up to 1 month
|
Change in perception of improvement in CIPN as assessed by Brief Pain Inventory-short form (BPI) questionnaire
Time Frame: Baseline up to 1 month
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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. The 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. |
Baseline up to 1 month
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Change in perception of improvement in CIPN as assessed by Pain Vigilance and Awareness Questionnaire (PVAQ)
Time Frame: Baseline up to 1 month
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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. The Pain Vigilance and Awareness Questionnaire (PVAQ) will assess attention to pain in terms of awareness, consciousness, vigilance, and observation of pain. |
Baseline up to 1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah Prinsloo, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-1134 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-02093 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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