Chemotherapy-induced Peripheral NeuropathyNCT04107272
Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
A study testing Real repetitive transcranial magnetic stimulation in people with Chemotherapy-induced Peripheral Neuropathy, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Real repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating the Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy: A Randomized Feasibility Study
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.
Read the 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.
- Being tested
- Real repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Repetitive transcranial magnetic stimulation, Pain, Feasibility
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real repetitive transcranial magnetic stimulationDevice
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.
Sham repetitive transcranial magnetic stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Real rTMS Receives: Device: Real repetitive transcranial magnetic stimulation |
| Control group | Sham comparator | Sham rTMS Receives: Device: Sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility rate
The proportion of screened patients meeting the inclusion criteria.
Measured: Through study completion, an average of 1 year.
Recruitment time
The mean number of participants been recruited each month.
Measured: Through study completion, an average of 1 year.
Recruitment rate
The proportion of eligible patients who are finally recruited in the study.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Appropriateness of clinical outcome measures
The proportion of incomplete questionnaires and neurological tests.
Measured: 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).
Measured: Baseline up to 5 weeks
Secondary outcomes (5)
Pain perception
The Chinese version of the Brief Pain Inventory (BPI) will be used to assess pain associated with CIPN. This instrument was developed and validated by Wang et al. (2009) for measuring severity (four scales) and interference (seven scales) of pain in cancer patients, which demonstrated good internal consistencies of both domains (Cronbach's α were 0.894 and 0.915, respectively).
Measured: Baseline up to 5 weeks
Neuropathic symptoms and signs
Total Neuropathy Score-nurse© (TNSn©) is a validated instrument to evaluate symptoms and signs associated with CIPN based on both patient-reported and clinician-assessed data including three symptom questions (distribution areas of numbness, tingling/paresthesias, and neuropathic pain) and testing of vibration and pinprick; each of the symptoms and signs is scored from 0 to 4, with higher score indicating worse condition (Smith, Cohen, Pett \& Beck, 2010).
Measured: Baseline up to 5 weeks
Miscellaneous symptoms associated with CIPN
The Chinese version of Edmonton Symptom Assessment System (C-ESAS) validated by Dong et al. (2015) will be used to explore whether the intervention would bring any change in the concurrently reported symptoms among cancer patients including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and potential miscellaneous symptoms that are not listed. Cronbach's α of the C-ESAS was 0.72, indicating an acceptable internal consistency.
Measured: Baseline up to 5 weeks
Health-related quality of life
Functional Assessment of Cancer Therapy-General questionnaire (FACT-G), a widely used self-reported questionnaire measuring health-related quality-of-life (QoL) in cancer patients, will be used in this study. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx) will be used to measure the participants' CIPN specific quality of life in this study. It is an 11-item tool added to the FACT measurement system for assessing cancer patients' symptoms and interference induced by neuropathy, which includes sensory, motor, and hearing problems, as well as dysfunctions associated with neuropathy. Good psychometrical properties of the FACT/GOG-Ntx have been demonstrated.
Measured: Baseline up to 5 weeks
Adverse Effects
To determine the safety of rTMS in this population, participants will be asked to report any adverse effect occur during the study. The adverse effects, including the type, occurrence, and duration, will be recorded using a standard form. According to the guidelines (Klein et al., 2015; Rossi et al., 2009), the potential adverse effects associated with rTMS are transient seizures, headaches, transient hearing changes, local pain, neck pain, toothache, and paresthesia. These potential adverse effects will be listed in the standard form, and will be filled out by the designated therapists based on their observation and the participants' self-report after each treatment session. If any adverse effect occurs but is not listed in the form, the therapist will record the condition in the "Other" column.
Measured: Baseline up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Molassiotis, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107272
- Sponsor's protocol ID
- HSEARS20201116005
- Status last verified
- Aug 2022
- First submitted
- 18 Sep 2019
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy: A Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT04107272
- Acronym / sponsor ID
- HSEARS20201116005
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Repetitive transcranial magnetic stimulation, Pain, Feasibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Real repetitive transcranial magnetic stimulationReal rTMS |
| Control group | Sham comparator | Device: Sham repetitive transcranial magnetic stimulationSham rTMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real repetitive transcranial magnetic stimulationThe 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 | Experimental group |
| Sham repetitive transcranial magnetic stimulationThe 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. | Device | Control group |
Primary outcome
Eligibility rate
Time frame: Through study completion, an average of 1 year.
The proportion of screened patients meeting the inclusion criteria.
Recruitment time
Time frame: Through study completion, an average of 1 year.
The mean number of participants been recruited each month.
Recruitment rate
Time frame: Through study completion, an average of 1 year.
The proportion of eligible patients who are finally recruited in the study.
Retention/attrition rate
Time frame: Through study completion, an average of 1 year.
The proportion of recruited participants who complete the study or who drop out from the study with or without any reason.
Appropriateness of clinical outcome measures
Time frame: Through study completion, an average of 1 year.
The proportion of incomplete questionnaires and neurological tests.
Participants' perceived effectiveness
Time frame: Baseline up to 5 weeks
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).
5 secondary outcomes
Pain perception
Time frame: Baseline up to 5 weeks
Neuropathic symptoms and signs
Time frame: Baseline up to 5 weeks
Miscellaneous symptoms associated with CIPN
Time frame: Baseline up to 5 weeks
Health-related quality of life
Time frame: Baseline up to 5 weeks
Adverse Effects
Time frame: Baseline up to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Molassiotis, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Real repetitive transcranial magnetic stimulation in people with Chemotherapy-induced Peripheral Neuropathy, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Molassiotis, PhD ((852) 2766-6396, alex.molasiotis@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rate (time frame: Through study completion, an average of 1 year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.