Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT04107272

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-03-31

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Real rTMS

Group Type: EXPERIMENTAL

Real repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

The real 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 real 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 real 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 real rTMS will be delivered by designated physical therapists using "figure-of-8" shaped coil.

Control group

Sham rTMS

Group Type: SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

The sham rTMS of this study will be delivered with the same active coil angled 90-degree way from the scalp. The intensity of sham rTMS will be set at lowest stimulator output that can generate similar noise to the real rTMS. The sham rTMS will be delivered in the same manner and duration with real rTMS.

Interventions

Real repetitive transcranial magnetic stimulation

The real 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 real 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 real 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 real rTMS will be delivered by designated physical therapists using "figure-of-8" shaped coil.

Intervention Type: DEVICE

Sham repetitive transcranial magnetic stimulation

The sham rTMS of this study will be delivered with the same active coil angled 90-degree way from the scalp. The intensity of sham rTMS will be set at lowest stimulator output that can generate similar noise to the real rTMS. The sham rTMS will be delivered in the same manner and duration with real rTMS.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Molassiotis, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Central Contacts

Alex Molassiotis, PhD

Role: CONTACT

alex.molasiotis@polyu.edu.hk

(852) 2766-6396

Mian Wang, MN

Role: CONTACT

mian.wang@connect.polyu.hk

(86) 151-0711-4663

Other Identifiers

HSEARS20201116005

Identifier Type: -

Identifier Source: org_study_id