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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Utah
Huntsman Cancer Institute at University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Janna Espinosa
Janna.Espinosa@hci.utah.edu
801-585-0571
Backup
Newaj Abdullah, MD
newaj.abdullah@hsc.utah.edu
801-585-0255
Time Frame
Start Date: 2025-08-27
Estimated Completion Date: 2028-09-15
Participants
Target number of participants: 19
Treatments
Experimental: Repetitive Transcranial Magnetic Stimulation (rTMS) Administration
Related Therapeutic Areas
Sponsors
Leads: University of Utah

This content was sourced from clinicaltrials.gov