Clinical trial NCT04107272: Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
Official title: Evaluating the Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy: A Randomized Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Chemotherapy-induced Peripheral Neuropathy
Repetitive transcranial magnetic stimulation
Pain
Feasibility
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 peripheral neuropathy in cancer patients.

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 chemotherapy will be recruited. After randomization, the experimental group (n = 30) will receive high-frequency rTMS, while the control group (n = 30) will receive sham rTMS. The rTMS will be delivered over M1 (hand representation) of dual hemispheres with 10 trains of 10 Hz pulses for 10 seconds, with a total of 1,000 pulses per hemisphere. The rTMS intensity will be set as 80% resting motor threshold and the interval between each train of pulses will be set as 50 seconds. The rTMS will be delivered as daily session for five consecutive days, followed by two fortnightly maintenance sessions during the follow-up period after the completion of five daily sessions. The rTMS will be delivered by designated physical therapists using "figure-of-8" shaped coil connected to an electromagnetic stimulator in the rehabilitation therapy room of the study hospitals in mainland China.

The research outcomes are feasibility (1. recruitment: i.e. the length of time spent on recruiting participants, the mean number of participants been recruited each month, and the proportion of eligible patients who are finally recruited in the study; 2. eligibility: the proportion of screened patients meeting the inclusion criteria; 3. retention and attrition rates: the proportion of recruited participants who complete the study or who drop out from the study with or without any reason; and 4. appropriateness of clinical outcome measures: the proportion of incomplete questionnaires and neurological tests, as well as the characteristics of the missing data.), acceptability (Chinese version of the Patients' Global Impression of Change \[PGIC\] scale), safety, and trend of improvement in pain, other related symptoms, and quality of life by rTMS in cancer patients with CIPN.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Eligibility rate
timeFrame: Through study completion, an average of 1 year.
measure: Recruitment time
timeFrame: Through study completion, an average of 1 year.
measure: Recruitment rate
timeFrame: Through study completion, an average of 1 year.
measure: Retention/attrition rate
timeFrame: Through study completion, an average of 1 year.
measure: Appropriateness of clinical outcome measures
timeFrame: Through study completion, an average of 1 year.
measure: Participants' perceived effectiveness
timeFrame: Baseline up to 5 weeks
Secondary outcomes:
measure: Pain perception
timeFrame: Baseline up to 5 weeks
measure: Neuropathic symptoms and signs
timeFrame: Baseline up to 5 weeks
measure: Miscellaneous symptoms associated with CIPN
timeFrame: Baseline up to 5 weeks
measure: Health-related quality of life
timeFrame: Baseline up to 5 weeks
measure: Adverse Effects
timeFrame: Baseline up to 5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Alex Molassiotis, PhD
role: PRINCIPAL_INVESTIGATOR
References: