Magnetic brain stimulation to reduce chemotherapy-related nerve pain in breast and gynecologic cancer survivors

Repetitive Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Breast and Gynecologic Cancer Survivors: A Pilot Study

This trial tries repetitive transcranial magnetic stimulation (rTMS) to see if it reduces chemotherapy-induced peripheral neuropathy pain in adult women treated for breast or gynecologic cancers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Utah (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT07120100 on ClinicalTrials.gov

What this trial studies

This interventional study delivers repetitive transcranial magnetic stimulation (rTMS) to adult female survivors who developed neuropathic pain after treatment with platinum agents, taxanes, or vinca alkaloids. Eligible participants report moderate or worse neuropathic pain (PNRS ≥4 and DN-4 ≥3) and must be on a stable neuropathic medication regimen for at least six weeks. Pain scores will be recorded before and after the rTMS treatment course to measure changes in neuropathic pain severity. The trial is conducted at the Huntsman Cancer Institute, University of Utah.

Who should consider this trial

Good fit: Adult females (≥18 years) with histologically confirmed breast or gynecologic cancer who developed neuropathic pain during or within one month after platinum, taxane, or vinca chemotherapy, have PNRS ≥4 and DN-4 ≥3, and have been on a stable neuropathic pain medication for at least six weeks are ideal candidates.

Not a fit: Patients who do not have chemotherapy-related neuropathy, who have pain below the study thresholds, who are not on a stable neuropathic medication regimen, or who cannot attend in-person rTMS sessions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, rTMS could provide a noninvasive option to reduce neuropathic pain and improve daily functioning for survivors with chemotherapy-induced peripheral neuropathy.

How similar studies have performed: Small trials of rTMS for various neuropathic pain conditions have shown promising but mixed results, and evidence specifically for chemotherapy-induced peripheral neuropathy remains limited and exploratory.

Eligibility criteria

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 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.

Where this trial is running

Salt Lake City, Utah

• Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Study coordinator: Janna Espinosa

Conditions: Breast Cancer Female, Gynecologic Cancer