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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer Female; Gynecologic Cancer

• Registration Number: NCT07120100
• Lead Sponsor: University of Utah

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-09-15
• Primary Completion: 2027-09-15
• Study Completion: 2028-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

• 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.

• Persistent neuropathic pain with current use of at least one neuropathic medication.

• Subjects must have been on a stable dose of neuropathic pain medication 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. 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.

Exclusion Criteria

• Evidence of recurrent disease 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 a neuroleptic medications or other drugs that lower seizure threshold will be excluded.

  --Note: Patients who are on tricyclic antidepressants will be asked to lower the dose to 50 mg daily at least one week prior to the initiation of rTMS treatment. If dose reduction would adversely affect the subject's underlying disease, the subject should be excluded from the study.

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Pain Numeric Rating Scale (PNRS) between screening and end of treatment in subjects who complete at least 7 rTMS treatments.	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.

Secondary Outcome Measures

Name	Time	Method
Change in scores from Brief Pain Inventory-Short Form at screening, end of rTMS, 4 weeks, and 12 weeks after treatment.	4 months	To evaluate the change in patient-reported outcomes.
Patient's Global Impression of Change (PGIC) score at end of rTMS, 1 week, 4 weeks, and 12 weeks after treatment.	4 months	To evaluate the change in patient-reported outcomes.
Change in scores from EQ-5D-5L at screening, end of rTMS, 4 weeks, and 12 weeks after treatment.	4 months	To evaluate the change in patient-reported outcomes.
Change in scores from EORTC-QLQ-CIPN-20 at screening, end of rTMS, 4 weeks, and 12 weeks after treatment.	4 months	To evaluate the change in patient-reported 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%.	2 years	To evaluate the safety of open-label 10-Hz rTMS of the motor cortex in individuals with CIPN.
Change in scores from PROMIS-29 at screening, end of rTMS, 4 weeks, and 12 weeks after treatment.	4 months	To evaluate the change in patient-reported outcomes.
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	To evaluate the feasibility of 10 sessions of open-label 10-Hz rTMS of the motor cortex in individuals with CIPN.
Change in Pain Numeric Rating Scale (PNRS) at screening, upon completion of at least 7 treatments, 1 week, 4 weeks and 12 weeks after treatment.	4 months	To evaluate the duration of pain (0- no pain to 10-worst pain imaginable) relief after treatment with rTMS.

Trial Locations

Locations (1)

Huntsman Cancer Institute at University of Utah; 🇺🇸 Salt Lake City, Utah, United States