Breast Cancer FemalerTMS for CIPNNCT07120100
Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy in Breast and Gynecologic Cancer Survivors
A study testing rTMS in people with Breast Cancer Female and Gynecologic Cancer, run by University of Utah at 1 site in United States.
Trial summary
The goal of this study is to evaluate the change in pain scores among patients with chemotherapy-induced peripheral neuropathy after receiving treatment with repetitive transcranial magnetic stimulation (rTMS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Gynecologic Cancer
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to 15 Sep 2028
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects aged ≥ 18 years.
- Histologically confirmed breast or gynecologic cancer.
- Developed neuropathic pain with the initiation of or within one month after completion of treatment with anti-neoplastic agents from the following class:
- Platinum-based drugs
- Taxanes
- Vinca alkaloids
Show all 24Show fewer
- Pain score 4 or more on the Pain Numeric Rating Scale (PNRS).
- Score 3 or more on the Douleur Neuropathique 4 (DN-4) questionnaire.
- Subjects must have failed at least one standard-of-care neuropathic medication.
- --- Note: Failure is defined as discontinuation of the standard-of-care neuropathic pain medication due to intolerable side effects or lack of analgesic benefit after continuing the medication for at least 6 weeks.
- Subjects who are currently on neuropathic medication must have been on a stable dose for at least 6 weeks prior to enrollment.
- -- Note: Additional washout periods for other pain medications may be needed and will be determined by the Investigator.
- For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
- Women < 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
- Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago; or
- Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- Subjects of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Evidence of recurrent breast or gynecologic cancer at the time of enrollment.
- Current or planned treatment with chemotherapy.
- --Note: Other anti-cancer treatments (e.g. hormone therapy and targeted therapies) are allowed at the Investigator's discretion.
- History of seizure, epilepsy, or other conditions that would, in the opinion of the investigator, negatively impact the patient's safety or ability to participate in the study.
- Presence of neuropathic pain unrelated to systemic cancer therapy, including but not limited to: painful diabetic neuropathy, HIV-induced neuropathy, neuropathic pain from radiation therapy and underlying cancer/other medical conditions.
- Presence of implantable devices including spinal cord stimulators, dorsal root ganglion stimulators, deep brain stimulators, cochlear implants, intrathecal pain pumps, and intracranial metallic objects which are incompatible with rTMS administration in the opinion of the treating investigator.
Show all 11Show fewer
- Subjects on medications that, in the opinion of the investigator, significantly lower seizure threshold will be excluded.
- Any condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- History of recent suicide attempt or active suicidal ideation that, in the opinion of the investigator, presents an increased risk for study participation
- Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
- Enrollment in another study that, in the opinion of the investigator, would negatively impact study participation or cause undue burden for the subject.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Janna Espinosa, 801-585-0571, Janna.Espinosa@hci.utah.edu
Newaj Abdullah, MD, 801-585-0255, newaj.abdullah@hsc.utah.edu
About this study
Official title: Repetitive Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Breast and Gynecologic Cancer Survivors: A Pilot Study
The goal of this study is to evaluate the change in pain scores among patients with chemotherapy-induced peripheral neuropathy after receiving treatment with repetitive transcranial magnetic stimulation (rTMS).
- Conditions
- Breast Cancer Female, Gynecologic Cancer
- Being tested
- rTMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Repetitive Transcranial Magnetic Stimulation will be administered Monday-Friday for two weeks (10 sessions total)
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) Administration | Experimental | Not described Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Numeric Rating Scale (PNRS) between screening and end of treatment in subjects who complete at least 7 rTMS treatments.
To assess the change in pain scores (0- no pain to 10-worst pain imaginable) after treatment with repetitive transcranial magnetic stimulation (rTMS) in patients with CIPN.
Measured: 5 months
Secondary outcomes (8)
The rTMS therapy will be considered safe if the proportion of subjects reporting treatment related grade 3 adverse device effects per Common Terminology Criteria for Adverse Events (CTCAE 5.0) is less than or equal to 5%.
To evaluate the safety of open-label 10-Hz rTMS of the motor cortex in individuals with CIPN.
Measured: 2 years
The rTMS therapy will be feasible if at least 70% of the treated subjects can complete at least 70% of the treatment sessions.
To evaluate the feasibility of 10 sessions of open-label 10-Hz rTMS of the motor cortex in individuals with CIPN.
Measured: 2 years
Change in Pain Numeric Rating Scale (PNRS)
To evaluate the duration of pain (0- no pain to 10-worst pain imaginable) relief after treatment with rTMS.
Measured: up to 4 weeks after initiation of study intervention
Change in Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29) v.2.1
To evaluate the change in patient-reported outcomes.
Each question usually has five response options ranging in value from one to five. The raw score is the sum of the values of the response to each question. From the raw score, the T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
This outcome measure will report the mean T-scores of 8 subscales; Physical Function (Range: 22.5-57), Anxiety (40.3-81.6), Depression (41.0-79.4), Fatigue (33.7-75.8), Sleep Disturbance (32-73.3), Social Roles (27.5-64.2), Pain Interference (41.6-75.6), and Cognitive Function (29.5-61.2).
Measured: up to 4 weeks after initiation of the study intervention
Change in Brief Pain Inventory-Short Form (BPI-SF) Scores
To evaluate the change in patient-reported outcomes. This outcome measure will report two BPI-SF subscales.
Pain Severity Score is the mean of 4 items. Scores range from 0-10, with lower scores indicating less pain and higher scores indicating more pain.
Pain Interference Score is the mean of 7 items. Scores range from 0-10, with lower scores indicating less pain interference and higher scores indicating more pain interference.
This outcome measure will report the mean of the Pain Severity and Pain Interference Scores.
Measured: up to 4-week after initiation of the study intervention
Change in Patient's Global Impression of Change (PGIC) Score
To evaluate the change in patient-reported outcomes.
The PGIC asks patients to rate how their pain has changed since the start of the study. This outcome measure will report the mean of the single-item, 7-point PGIC scale from 0 No change (or the condition has gotten worse) to 7 A great deal better, and considerable improvement that has made all the difference.
Measured: up to 4-week after initiation of the study intervention
Change in EuroQol 5-Dimension, 5-Level (EQ-5D-5L)
To evaluate the change in patient-reported outcomes.
The EQ-5D-5L assesses health status across five dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated from Level 1 (no problems) to Level 5 (extreme problems).
For analysis, each dimension will be dichotomized into two categories: No Problems (Level 1) Problems (Levels 2-5) The outcome measure will report the number of participants in each category for each health dimension.
Measured: up to 4-week after initiation of the study intervention
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC-QLQ-CIPN-20)
To evaluate the change in patient-reported outcomes.
The EORTC QLQ-CIPN20 is 20 items on a 1-4 Likert scale, where 1 is "not at all" and 4 is "very much". Items are summed to obtain the raw score, then converted to a 0-100 scale.
Higher scores indicate more severe chemotherapy-induced peripheral neuropathy (CIPN), lower scores indicate less CIPN
Measured: up to 4-week after initiation of the study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start27 Aug 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120100
- Sponsor's protocol ID
- HCI188734
- Acronym
- rTMS for CIPN
- Status last verified
- May 2026
- First submitted
- 30 Jul 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Breast and Gynecologic Cancer Survivors: A Pilot Study
- ClinicalTrials.gov ID
- NCT07120100
- Acronym / sponsor ID
- rTMS for CIPN / HCI188734
- Conditions
- Breast Cancer Female, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 13 Aug 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.
The goal of this study is to evaluate the change in pain scores among patients with chemotherapy-induced peripheral neuropathy after receiving treatment with repetitive transcranial magnetic stimulation (rTMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) Administration | Experimental | Device: rTMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Female subjects aged ≥ 18 years.
- Histologically confirmed breast or gynecologic cancer.
- Developed neuropathic pain with the initiation of or within one month after completion of treatment with anti-neoplastic agents from the following class:
- Pain score 4 or more on the Pain Numeric Rating Scale (PNRS).
- Score 3 or more on the Douleur Neuropathique 4 (DN-4) questionnaire.
Key exclusion criteria (11 listed)
- Evidence of recurrent breast or gynecologic cancer at the time of enrollment.
- Current or planned treatment with chemotherapy.
- --Note: Other anti-cancer treatments (e.g. hormone therapy and targeted therapies) are allowed at the Investigator's discretion.
- History of seizure, epilepsy, or other conditions that would, in the opinion of the investigator, negatively impact the patient's safety or ability to participate in the study.
- Presence of neuropathic pain unrelated to systemic cancer therapy, including but not limited to: painful diabetic neuropathy, HIV-induced neuropathy, neuropathic pain from radiation therapy and underlying cancer/other medical conditions.
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 |
|---|---|---|
| rTMSRepetitive Transcranial Magnetic Stimulation will be administered Monday-Friday for two weeks (10 sessions total) | Device | Repetitive Transcranial Magnetic Stimulation (rTMS) Administration |
Primary outcome
Change in Pain Numeric Rating Scale (PNRS) between screening and end of treatment in subjects who complete at least 7 rTMS treatments.
Time frame: 5 months
To assess the change in pain scores (0- no pain to 10-worst pain imaginable) after treatment with repetitive transcranial magnetic stimulation (rTMS) in patients with CIPN.
8 secondary outcomes
The rTMS therapy will be considered safe if the proportion of subjects reporting treatment related grade 3 adverse device effects per Common Terminology Criteria for Adverse Events (CTCAE 5.0) is less than or equal to 5%.
Time frame: 2 years
The rTMS therapy will be feasible if at least 70% of the treated subjects can complete at least 70% of the treatment sessions.
Time frame: 2 years
Change in Pain Numeric Rating Scale (PNRS)
Time frame: up to 4 weeks after initiation of study intervention
Change in Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29) v.2.1
Time frame: up to 4 weeks after initiation of the study intervention
Change in Brief Pain Inventory-Short Form (BPI-SF) Scores
Time frame: up to 4-week after initiation of the study intervention
Change in Patient's Global Impression of Change (PGIC) Score
Time frame: up to 4-week after initiation of the study intervention
Change in EuroQol 5-Dimension, 5-Level (EQ-5D-5L)
Time frame: up to 4-week after initiation of the study intervention
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC-QLQ-CIPN-20)
Time frame: up to 4-week after initiation of the study intervention
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 2 Jun 2026.
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Breast Cancer Female and Gynecologic Cancer, run by University of Utah at 1 site in United States.
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 24 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. 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 United States. 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?
Contact Janna Espinosa (801-585-0571, Janna.Espinosa@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Numeric Rating Scale (PNRS) between screening and end of treatment in subjects who complete at least 7 rTMS treatments. (time frame: 5 months). 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 2 Jun 2026.