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