Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether repeated magnetic pulses to the brain, called rTMS, change pain scores. It is for women who have survived breast cancer or cancer of the female reproductive organs and have nerve pain caused by chemotherapy.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older with breast cancer or cancer of the female reproductive organs confirmed by a tissue test.
- Nerve pain began when starting chemotherapy or within one month after finishing it. The drugs must have been platinum-based drugs, taxanes, or vinca alkaloids.
- A pain rating of at least 4 and a score of at least 3 on the DN-4 nerve pain questionnaire.
- Tried at least one standard nerve pain medicine but stopped because of severe side effects or no pain relief after at least 6 weeks.
- If taking nerve pain medicine now, the dose must have stayed the same for at least 6 weeks. The study doctor may require a break from other pain medicines.
- Have a negative pregnancy test or meet the study's rules for menopause or surgery to prevent pregnancy. These rules depend on age, periods, hormone use, hormone tests, and surgery history.
- If able to become pregnant, agree to use a highly effective birth control method.
- Be able to understand the study, agree to join, and sign a consent form.
Who can't join
- Breast cancer or cancer of the female reproductive organs has come back.
- Receiving or planning chemotherapy. The study doctor may allow other cancer treatments.
- A history of seizures or epilepsy, or taking medicines the study doctor believes greatly raise seizure risk.
- Nerve pain from causes other than cancer medicines, such as diabetes, HIV, radiation, cancer itself, or other illnesses.
- An implanted device or metal inside the skull that the study doctor believes is not safe with rTMS. Examples include nerve stimulators, hearing implants, and implanted pain pumps.
- A condition that makes the study unsafe or limits the ability to understand it, give consent, follow study steps, or finish it.
- A recent suicide attempt or current thoughts of suicide that the study doctor believes make joining too risky.
- Taking part in another study that the study doctor believes would interfere or create too much burden.
Simplified for readability. The official criteria below are what the study team uses.
Official 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. * Subjects must have failed at least one standard-of-care neuropathic medication. \--- Note: Failure is defined as discontinuation of the standard-of-care neuropathic pain medication due to intolerable side effects or lack of analgesic benefit after continuing the medication for at least 6 weeks. * Subjects who are currently on neuropathic medication must have been on a stable dose 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 or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). 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.
Study sites (1)
UT
- Huntsman Cancer Institute at University of Utah · Salt Lake City, UT 84112Janna Espinosa · Study contact · 801-585-0571 · Janna.Espinosa@hci.utah.eduNewaj Abdullah, MD · Study contact · 801-585-0255 · newaj.abdullah@hsc.utah.eduMore trials in Salt Lake City