NCT07120100招募中不适用
Repetitive Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Breast and Gynecologic Cancer Survivors: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Pain Numeric Rating Scale (PNRS) between screening and end of treatment in subjects who complete at least 7 rTMS treatments.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •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.
研究组 & 干预措施
Repetitive Transcranial Magnetic Stimulation (rTMS) Administration
Experimental
干预措施: rTMS (Device)
结局指标
主要结局
Change in Pain Numeric Rating Scale (PNRS) between screening and end of treatment in subjects who complete at least 7 rTMS treatments.
时间窗: 5 months
To assess the change in pain scores (0- no pain to 10-worst pain imaginable) after treatment with repetitive transcranial magnetic stimulation (rTMS) in patients with CIPN.
次要结局
- The rTMS therapy will be feasible if at least 70% of the treated subjects can complete at least 70% of the treatment sessions.(2 years)
- 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%.(2 years)
- Change in Pain Numeric Rating Scale (PNRS)(up to 4 weeks after initiation of study intervention)
- Change in Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29) v.2.1(up to 4 weeks after initiation of the study intervention)
- Change in Brief Pain Inventory-Short Form (BPI-SF) Scores(up to 4-week after initiation of the study intervention)
- Change in Patient's Global Impression of Change (PGIC) Score(up to 4-week after initiation of the study intervention)
- Change in EuroQol 5-Dimension, 5-Level (EQ-5D-5L)(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)(up to 4-week after initiation of the study intervention)
研究者
研究点 (1)
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