Status:
UNKNOWN
Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study aims to evaluate the feasibility of a repetitive transcranial magnetic simulation (rTMS) protocol developed for managing pain and other related symptoms associated with chemotherapy-induced ...
Detailed Description
A total of 60 cancer patients who are aged 18 years or above and have persistent peripheral neuropathy for at least 3 months after completion of oxaliplatin-, paclitaxel-, or docetaxel-based chemother...
Eligibility Criteria
Inclusion
- have completed oxaliplatin-, paclitaxel-, or docetaxel-based chemotherapy for at least 3 months;
- complain of persistent symptoms associated with CIPN such as numbness, tingling, burning, or pain with scores ≥ 4 on a numerical rating scale for average daily intensity (0-10, with 10 being the worst) and/or determined as grade 2 or higher CIPN by oncologist according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 (2017);
- with decreased vibration and/or pinprick sensations according to neurological test (provided by the doctoral researcher when patients was referred by their oncologists);
- have a Karnofsky Performance Score ≥ 70;
- can travel to the research hospitals for receiving the study intervention.
Exclusion
- having brain tumor or brain metastasis;
- having pregnancy;
- having implanted medical devices;
- having history of epilepsy, brain lesion, head trauma, neurosurgical procedures, or intracranial hypertension;
- having a diagnosis of psychiatric disorder (e.g. bipolar, ongoing major depression, or schizophrenia) and/or treating with antipsychotic drugs;
- having preexisting peripheral neuropathy before initiation of chemotherapy; g) withdrawing from alcohol or sedative medications;
- having a life expectancy less than six months;
- treating with naloxone, which can block analgesic effect of rTMS over M1;
- previously treated with rTMS. Patients receiving any other treatment for CIPN may not be excluded, but they will be required not to change the type and dosage of the current treatments. Furthermore, such information will be collected as baseline clinical data and will be treated as confounding factors during data analysis.
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04107272
Start Date
December 1 2022
End Date
March 1 2024
Last Update
August 24 2022
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