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New treatment option for Breast Cancer Female
Official title Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy in Breast and Gynecologic Cancer Survivors
ClinicalTrials.gov ID: NCT07120100
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female people 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...
- Platinum-based drugs
- Taxanes
You likely can't join if
- 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...
- History of seizure, epilepsy, or other conditions that would, in the opinion of the investigator, negatively impact the patient's safety or ability...
- Presence of neuropathic pain unrelated to systemic cancer therapy, including but not limited to: painful diabetic neuropathy, HIV-induced neuropathy...
- Presence of implantable devices including spinal cord stimulators, dorsal root ganglion stimulators, deep brain stimulators, cochlear implants...
- people on medications that, in the opinion of the investigator, significantly lower seizure threshold will be excluded.
See the full eligibility criteria
Who can join
- Female people 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.
- people 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...
- people 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...
- For female people: 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...
- 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).
- people 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.
What rules you out
- 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...
- 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...
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.