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

NCT04107272 | Unknown

• 1 other identifier: HSEARS20201116005
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Chemotherapy-induced Peripheral Neuropathy; Repetitive transcranial magnetic stimulation; Pain; Feasibility

Outcome Measures

Primary Outcomes (6)

• Eligibility rate

  The proportion of screened patients meeting the inclusion criteria.

  Through study completion, an average of 1 year.

• Recruitment time

  The mean number of participants been recruited each month.

  Through study completion, an average of 1 year.

• Recruitment rate

  The proportion of eligible patients who are finally recruited in the study.

  Through study completion, an average of 1 year.

• Retention/attrition rate

  The proportion of recruited participants who complete the study or who drop out from the study with or without any reason.

  Through study completion, an average of 1 year.

• Appropriateness of clinical outcome measures

  The proportion of incomplete questionnaires and neurological tests.

  Through study completion, an average of 1 year.

• Participants' perceived effectiveness

  In this study, affective attitude and perceived effectiveness will be measured by using the Chinese version of the Patient Global Impression of Change (PGIC) scale, a single-item 7-point numerical rating scale from 1 to 7 demonstrating participants' subjective perception of improvement and satisfaction after receiving the intervention (Hurst \& Bolton, 2004). The PGIC scale has been recommended by the rTMS research guideline for pain (Klein et al., 2015).

  Baseline up to 5 weeks

Secondary Outcomes (5)

• Pain perception

  Baseline up to 5 weeks

• Neuropathic symptoms and signs

  Baseline up to 5 weeks

• Miscellaneous symptoms associated with CIPN

  Baseline up to 5 weeks

• Health-related quality of life

  Baseline up to 5 weeks

• Adverse Effects

  Baseline up to 5 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Real rTMS

Device: Real repetitive transcranial magnetic stimulation

Control group

SHAM COMPARATOR

Sham rTMS

Device: Sham repetitive transcranial magnetic stimulation

Interventions

Real repetitive transcranial magnetic stimulation 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.

Experimental group

Sham repetitive transcranial magnetic stimulation 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alex Molassiotis, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Molassiotis, PhD

CONTACT

(852) 2766-6396; alex.molasiotis@polyu.edu.hk

Mian Wang, MN

CONTACT

(86) 151-0711-4663; mian.wang@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 27, 2019
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 24, 2022

Record last verified: 2022-08