Breast Cancer FemalesCIPNNCT07151963
Effects of Prolonged Continuous Theta Burst Stimulation in Chemotherapy-induced Peripheral Neuropathy
A study testing prolonged continuous TBS and 20 Hz rTMS in people with Breast Cancer Females, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Laboratory studies have shown that prolonged continuous theta burst stimulation (pcTBS) provides better pain relief than 10 Hz repetitive transcranial magnetic stimulation (rTMS), with a shorter stimulation time, making it more practical for clinical use. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Females
- What is being tested?
- prolonged continuous TBS and 20 Hz rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Feb 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients aged between 18- and 80-years-old with CIPN
- history of receiving chemotherapy including taxane-based neurotoxic agents
- with neuropathic pain, score≥3 in a 0-10 VAS pain scale.
- with fair cognition and can cooperate to evaluate pain severity.
- neither at end-stage cancer nor at the estimated survival time less than 6 months.
Who cannot join
- brain tumor or history of epilepsy
- intracranial metallic devices, artificial cochleae, pacemakers, or any other metal device
- recent myocardial ischemia or unstable angina
- severe cognitive dysfunction or pregnancy
- injuries or fractures in the part of neuropathic pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Prolonged Continuous Theta Burst Stimulation in Chemotherapy-induced Peripheral Neuropathy: a Randomized Cross- Over Trial
Laboratory studies have shown that prolonged continuous theta burst stimulation (pcTBS) provides better pain relief than 10 Hz repetitive transcranial magnetic stimulation (rTMS), with a shorter stimulation time, making it more practical for clinical use. Chemotherapy-induced peripheral neuropathy often causes neuropathic pain in cancer patients. The aims of this study are:
- To compare the effects of pcTBS and 20 Hz rTMS on chemotherapy-induced peripheral neuropathy;
- To compare the effects of pcTBS applied to the primary motor cortex versus the dorsolateral prefrontal cortex on neuropathic pain as well as depression and anxiety.
Read the detailed description
Phase 1: Investigators will recruit 20 breast cancer patients who have chemotherapy-induced peripheral neuropathy. They will be randomly divided into two groups.
- Group 1 will first receive pcTBS. After an 8-week break, they will then receive 20 Hz rTMS.
- Group 2 will receive the treatments in the opposite order.
Each treatment lasts for 5 consecutive days. Before and after each treatment, patients will be assessed using:
- A pain visual analog scale (to measure pain levels)
- A Neuropathic Pain Symptom Inventory (The scale ranges from zero to 10, with zero indicating no pain at all and 10 indicating the worst imaginable pain)
- * A Depression Anxiety Stress Scale 21 (The scale ranges from 0-63, with a higher scores mean a worse outcome)
- * Clinical pressure pain threshold tests (Higher PPT values indicate a higher tolerance to pressure pain (less sensitivity).
- Nerve conduction studies Phase 2: Another 20 breast cancer patients with chemotherapy-induced peripheral neuropathy will be recruited and randomly divided into two groups.
- Group 1 will first receive pcTBS on the primary motor cortex. After an 8-week break, they will receive the same stimulation on the left dorsolateral prefrontal cortex.
- Group 2 will receive the treatments in the opposite order.
- Conditions
- Breast Cancer Females
- Being tested
- prolonged continuous TBS, 20 Hz rTMS
- Keywords
- conventional repetitive transcranial magnetic stimulation, breast cancer, chemotherapy induced peripheral neuropathy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolonged continuous TBSDevice
prolonged continuous theta burst stimulation
20 Hz rTMSDevice
20 Hz repetitive transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| prolonged continuous TBS (pcTBS) | Experimental | pcTBS over M1 Receives: Device: prolonged continuous TBS |
| 20 Hz rTMS | Active comparator | 20 Hz rTMS over M1 Receives: Device: 20 Hz rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue pain scale (VAS pain scale)
visual analogue pain scale (VAS) range from 0-100, with a higher score inducating more pain
Measured: baseline, pre-intervention and immediately after completion the intervention and at 4 weeks follow-up
Secondary outcomes (3)
Depression Anxiety Stress Scale 21
Depression Anxiety Stress Scale 21 scale ranges from 0-63, with a higher scores mean a worse outcome.
Measured: baseline and after completion the intervention and at 4 weeks follow-up
pressure pain threshold test
- Higher pressure pain threshold values indicate a higher tolerance to pressure pain (less sensitivity).
Measured: baseline and after completion the intervention and at 4 weeks follow-up
Neuropathic Pain Symptom Inventory
Neuropathic Pain Symptom Inventory ranges from zero to 10, with zero indicating no pain at all and 10 indicating the worst imaginable pain.
Measured: baseline and after completion the intervention and at 4 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start17 Feb 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemalesStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Shiung Horng, MD., PhD., Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151963
- Sponsor's protocol ID
- 13-IRB009
- Acronym
- CIPN
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidential data
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prolonged Continuous Theta Burst Stimulation in Chemotherapy-induced Peripheral Neuropathy: a Randomized Cross- Over Trial
- ClinicalTrials.gov ID
- NCT07151963
- Acronym / sponsor ID
- CIPN / 13-IRB009
- Conditions
- Breast Cancer Females
- Keywords
- conventional repetitive transcranial magnetic stimulation, breast cancer, chemotherapy induced peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Sep 2025 (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.
Laboratory studies have shown that prolonged continuous theta burst stimulation (pcTBS) provides better pain relief than 10 Hz repetitive transcranial magnetic stimulation (rTMS), with a shorter stimulation time, making it more practical for clinical use. Chemotherapy-induced peripheral neuropathy often causes neuropathic pain in cancer patients. The aims of this study are:
- To compare the effects of pcTBS and 20 Hz rTMS on chemotherapy-induced peripheral neuropathy;
- To compare the effects of pcTBS applied to the primary motor cortex versus the dorsolateral prefrontal cortex on neuropathic pain as well as depression and anxiety.
Detailed description
Phase 1: Investigators will recruit 20 breast cancer patients who have chemotherapy-induced peripheral neuropathy. They will be randomly divided into two groups.
- Group 1 will first receive pcTBS. After an 8-week break, they will then receive 20 Hz rTMS.
- Group 2 will receive the treatments in the opposite order.
Each treatment lasts for 5 consecutive days. Before and after each treatment, patients will be assessed using:
- A pain visual analog scale (to measure pain levels)
- A Neuropathic Pain Symptom Inventory (The scale ranges from zero to 10, with zero indicating no pain at all and 10 indicating the worst imaginable pain)
- * A Depression Anxiety Stress Scale 21 (The scale ranges from 0-63, with a higher scores mean a worse outcome)
- * Clinical pressure pain threshold tests (Higher PPT values indicate a higher tolerance to pressure pain (less sensitivity).
- Nerve conduction studies Phase 2: Another 20 breast cancer patients with chemotherapy-induced peripheral neuropathy will be recruited and randomly divided into two groups.
- Group 1 will first receive pcTBS on the primary motor cortex. After an 8-week break, they will receive the same stimulation on the left dorsolateral prefrontal cortex.
- Group 2 will receive the treatments in the opposite order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prolonged continuous TBS (pcTBS) | Experimental | Device: prolonged continuous TBSpcTBS over M1 |
| 20 Hz rTMS | Active comparator | Device: 20 Hz rTMS20 Hz rTMS over M1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- breast cancer patients aged between 18- and 80-years-old with CIPN
- history of receiving chemotherapy including taxane-based neurotoxic agents
- with neuropathic pain, score≥3 in a 0-10 VAS pain scale.
- with fair cognition and can cooperate to evaluate pain severity.
- neither at end-stage cancer nor at the estimated survival time less than 6 months.
Key exclusion criteria (5 listed)
- brain tumor or history of epilepsy
- intracranial metallic devices, artificial cochleae, pacemakers, or any other metal device
- recent myocardial ischemia or unstable angina
- severe cognitive dysfunction or pregnancy
- injuries or fractures in the part of neuropathic pain
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 |
|---|---|---|
| prolonged continuous TBSprolonged continuous theta burst stimulation | Device | prolonged continuous TBS (pcTBS) |
| 20 Hz rTMS20 Hz repetitive transcranial magnetic stimulation | Device | 20 Hz rTMS |
Primary outcome
visual analogue pain scale (VAS pain scale)
Time frame: baseline, pre-intervention and immediately after completion the intervention and at 4 weeks follow-up
visual analogue pain scale (VAS) range from 0-100, with a higher score inducating more pain
3 secondary outcomes
Depression Anxiety Stress Scale 21
Time frame: baseline and after completion the intervention and at 4 weeks follow-up
pressure pain threshold test
Time frame: baseline and after completion the intervention and at 4 weeks follow-up
Neuropathic Pain Symptom Inventory
Time frame: baseline and after completion the intervention and at 4 weeks follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. confidential data
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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.
Yi-Shiung Horng, MD., PhD. principal investigator
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prolonged continuous TBS and 20 Hz rTMS in people with Breast Cancer Females, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. 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 Taiwan. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue pain scale (VAS pain scale) (time frame: baseline, pre-intervention and immediately after completion the intervention and at 4 weeks follow-up). 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 11 Sep 2025.