NCT04107272

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

Evaluating the Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy: A Randomized Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2024-03-01
• First posted: 2019-09-27
• Last updated: 2022-08-24