Chemotherapy-induced Peripheral NeuropathyNCT04833920
Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy
A study testing transcranial dirrect current brain stimuation in people with Chemotherapy-induced Peripheral Neuropathy, run by Assiut University at 1 site in Egypt.
Trial summary
Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- transcranial dirrect current brain stimuation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to Jun 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any stage of cancer, with a confirmed treatment plan consisting of taxane-based or oxaliplatin-based chemotherapy, neuropathic pain and/or peripheral sensory neuropathy with VAS score ≥ 3 that are resistant to medical treatment
Who cannot join
- patients with intracranial metallic devices or with pacemakers or any other device. - -W those with extensive myocardial ischemia,
- higher brain dysfunction,
- migraine headache,
- brain cancer or metastasis and
- those known to have epilepsy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute
Asyut, 11715
Shereen M Kamal, Lecturer, 01006279209, sheridouh79@yahoo.com
About this study
Official title: Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy
Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin)
Read the detailed description
Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) . CIPN is one of several long term side effects of anticancer medications that can appear during and after treatment. CIPN symptoms include pain, dysesthesia, motor and sensory disorders. CIPN can also be insufficiently responsive to pharmaceutical therapy similar to other types of refractory neuropathic pain This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation (CE-tDCS) over the primary motor cortex (M) in management of chemotherapy induced peripheral neuropathy.
- Being tested
- transcranial dirrect current brain stimuation
- Keywords
- brain stimulation, chemotherapy induced peripheral neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial dirrect current brain stimuationDevice
tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days (one session /day),
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Active comparator | tDCS targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days Receives: Device: transcranial dirrect current brain stimuation |
| sham tDCS | Sham comparator | tDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds Receives: Device: transcranial dirrect current brain stimuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the visual analogue scale
patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable
Measured: 0 (prestimulation), on the 5th day, 15th days and one month after the last session
Secondary outcomes (1)
changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS)
the patients will be asked to describe his pain by answering questions in yes or no; score ≥ 12 suggests neuropathic pain is likely to be involved and score < 12 suggests that neuropathic pain is unlikely to be involved
Measured: 0 (prestimulation),on the 5th day, 15th days and one month after the last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Apr 2021
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (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 Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
- Investigators
- Shereen M Kamal, Associate Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833920
- Sponsor's protocol ID
- 539
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04833920
- Acronym / sponsor ID
- 539
- Keywords
- brain stimulation, chemotherapy induced peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 6 Apr 2021 (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.
Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin)
Detailed description
Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) . CIPN is one of several long term side effects of anticancer medications that can appear during and after treatment. CIPN symptoms include pain, dysesthesia, motor and sensory disorders. CIPN can also be insufficiently responsive to pharmaceutical therapy similar to other types of refractory neuropathic pain This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation (CE-tDCS) over the primary motor cortex (M) in management of chemotherapy induced peripheral neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Active comparator | Device: transcranial dirrect current brain stimuationtDCS targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days |
| sham tDCS | Sham comparator | Device: transcranial dirrect current brain stimuationtDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any stage of cancer, with a confirmed treatment plan consisting of taxane-based or oxaliplatin-based chemotherapy, neuropathic pain and/or peripheral sensory neuropathy with VAS score ≥ 3 that are resistant to medical treatment
Key exclusion criteria (5 listed)
- patients with intracranial metallic devices or with pacemakers or any other device. - -W those with extensive myocardial ischemia,
- higher brain dysfunction,
- migraine headache,
- brain cancer or metastasis and
- those known to have epilepsy
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 |
|---|---|---|
| transcranial dirrect current brain stimuationtDCS (2 mA) targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days (one session /day), | Device | active tDCS, sham tDCS |
Primary outcome
changes in the visual analogue scale
Time frame: 0 (prestimulation), on the 5th day, 15th days and one month after the last session
patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable
1 secondary outcome
changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS)
Time frame: 0 (prestimulation),on the 5th day, 15th days and one month after the last session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Shereen M Kamal, Associate Professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial dirrect current brain stimuation in people with Chemotherapy-induced Peripheral Neuropathy, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 5 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 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Shereen M Kamal, Associate professor (01006279209, sheridouh79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the visual analogue scale (time frame: 0 (prestimulation), on the 5th day, 15th days and one month after the last session). 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 6 Apr 2021.