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rTMS for Neuropathy in Cancer Patients
N/A
Waitlist Available
Led By Sarah Prinsloo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No plans to change the type of pain medication (if a patient is on pain medication)
Grade 2 or higher neuropathic symptoms according to the National Cancer Institute's 4 point grading scale
Must not have
Patients who are taking any antipsychotic medications
Patients who have a history of head injury, focal brain lesions, or known seizure activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 month
Summary
This trial studies the use of rTMS to improve neuropathy caused by oxaliplatin chemotherapy. rTMS is a noninvasive procedure that uses magnetic impulses to stimulate the brain and change its activity.
Who is the study for?
This trial is for English-speaking stage I-IV cancer patients who've had oxaliplatin chemotherapy and suffer from moderate to severe neuropathy. They must be stable on pain meds, able to visit MD Anderson for sessions, have an ECOG status of 0-2, and their neuropathy should be at least 3 months old. Excluded are those with bipolar disorder or schizophrenia, brain implants or pacemakers not MRI safe, antipsychotic use, brain metastases or CNS disease, head injury history, known seizures, or drug withdrawal.
What is being tested?
The study tests if rTMS can improve chemotherapy-induced neuropathy in cancer patients. It involves small magnetic pulses applied to the scalp aimed at altering brain activity. Participants will either receive this intervention or a sham (fake) treatment as part of the control group while continuing their usual care routines.
What are the potential side effects?
rTMS may cause discomfort at the site of stimulation on the scalp, headache during initial treatments which usually diminishes over time; rare risks include seizure induction especially in predisposed individuals but overall it's considered a low-risk procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not planning to change my current pain medication.
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I experience moderate to severe nerve pain or tingling.
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I have had nerve pain symptoms for at least 3 months.
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I have received oxaliplatin chemotherapy for my stage I-IV cancer.
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I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking antipsychotic medication.
Select...
I have had a head injury, brain lesions, or seizures.
Select...
I have been diagnosed with bipolar disorder or schizophrenia.
Select...
I have brain metastases or active brain disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in perceptions of chemotherapy-induced peripheral neuropathy (CIPN)
Secondary study objectives
Change in cortical activity
Change in perception of improvement in CIPN as assessed by Brief Pain Inventory-short form (BPI) questionnaire
Change in perception of improvement in CIPN as assessed by Edmonton Symptom Assessment System (ESAS) questionnaire
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group I (rTMS)Experimental Treatment3 Interventions
Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.
Group II: Group III (standard of care)Active Control3 Interventions
Patients receive standard of care.
Group III: Group II (sham rTMS)Placebo Group3 Interventions
Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1170
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,291 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,031 Total Patients Enrolled
Sarah PrinslooPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
794 Total Patients Enrolled