RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-08-27

Study Completion:2028-09-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07120100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* Evidence of recurrent disease at the time of enrollment. * Current or planned treatment with chemotherapy. * 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. * 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.

Inclusion Criteria

Exclusion 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.
* 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.

* Evidence of recurrent disease at the time of enrollment.
* Current or planned treatment with chemotherapy.
* 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.
* 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.

Contacts and Locations

Study Contact

Janna Espinosa

CONTACT

801-585-0571

Janna.Espinosa@hci.utah.edu

Newaj Abdullah, MD

CONTACT

801-585-0255

newaj.abdullah@hsc.utah.edu

Study Locations (Sites)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-27

Study Completion Date2028-09-15

Study Record Updates

Study Start Date2025-08-27

Study Completion Date2028-09-15

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer Female
Gynecologic Cancer