Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy in Breast and Gynecologic Cancer Survivors

NCT07120100 | Recruiting DMC FDA Device

• 1 other identifier: HCI188734
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Breast Cancer Female; Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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%.

  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.

  2 years

• Change in Pain Numeric Rating Scale (PNRS)

  up to 4 weeks after initiation of study intervention

• Change in Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29) v.2.1

  up to 4 weeks after initiation of the study intervention

• Change in Brief Pain Inventory-Short Form (BPI-SF) Scores

  up to 4-week after initiation of the study intervention

Study Arms (1)

Repetitive Transcranial Magnetic Stimulation (rTMS) Administration

EXPERIMENTAL

Device: rTMS

Interventions

rTMS DEVICE

Repetitive Transcranial Magnetic Stimulation will be administered Monday-Friday for two weeks (10 sessions total)

Repetitive Transcranial Magnetic Stimulation (rTMS) Administration

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Central Study Contacts

Janna Espinosa

CONTACT

801-585-0571; Janna.Espinosa@hci.utah.edu

Newaj Abdullah, MD

CONTACT

801-585-0255; newaj.abdullah@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 13, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

US (1)