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

Официальное название

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

Обзор

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).

Вмешательства

• Устройство rTMS
  Repetitive Transcranial Magnetic Stimulation will be administered Monday-Friday for two weeks (10 sessions total)

Первичные конечные точки

• Change in Pain Numeric Rating Scale (PNRS) between screening and end of treatment in subjects who complete at least 7 rTMS treatments. [Срок оценки: 5 months]

Вторичные конечные точки (8)

• The rTMS therapy will be considered safe if the proportion of subjects reporting treatment related grade 3 adverse device effects per Common Terminology Criteria for Adverse Events (CTCAE 5.0) is less than or equal to 5%. [Срок оценки: 2 years]
• The rTMS therapy will be feasible if at least 70% of the treated subjects can complete at least 70% of the treatment sessions. [Срок оценки: 2 years]
• Change in Pain Numeric Rating Scale (PNRS) [Срок оценки: up to 4 weeks after initiation of study intervention]
• Change in Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29) v.2.1 [Срок оценки: up to 4 weeks after initiation of the study intervention]
• Change in Brief Pain Inventory-Short Form (BPI-SF) Scores [Срок оценки: up to 4-week after initiation of the study intervention]
• Change in Patient's Global Impression of Change (PGIC) Score [Срок оценки: up to 4-week after initiation of the study intervention]
• Change in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) [Срок оценки: up to 4-week after initiation of the study intervention]
• Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC-QLQ-CIPN-20) [Срок оценки: up to 4-week after initiation of the study intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Huntsman Cancer Institute at University of Utah — Salt Lake City

Идентификаторы

NCT: NCT07120100 · HCI188734

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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