Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy
研究概览
简要总结
This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer, bortezomib for multiple myeloma, oxaliplatin-based regimens for colorectal cancer, or vincristine for lymphoma.. Demographic data, medical history, electronic PROs, ClinROs blood biomarkers including NF-L, PGx DNA analyses and Bedside-QST will be assessed at Baseline. The Observation Period will initiate with the first dose of chemotherapy and conclude with the last dose of chemotherapy. During the Observation Period, participants will be evaluated for the development of CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will be measured at various timepoints corresponding with treatment regimen schedules throughout the observation period. The Post Chemotherapy Follow-up Period will begin with the first visit after the last dose of chemotherapy and conclude 6 months after the last dose of chemotherapy. During the Post Chemotherapy Follow-up Period, participants will be evaluated for CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will also be measured at the beginning and at the end of the Post-Chemotherapy Follow-up Period. PROs will be assessed electronically on a monthly basis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following criteria must be met in order to be enrolled in the study:
- •Age ≥18 years
- •Life expectancy ≥6 months
- •Participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 CIPN (exception, patients with multiple myeloma treated with bortezomib, CTCAE Grade <=1)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Breast cancer only:
- •Breast cancer beginning treatment with paclitaxel or docetaxel with curative intent (i.e., not metastatic disease beyond regional lymph nodes)
- •Planned minimum of 6 cycles of chemotherapy
- •Lymphoma only:
- •Incident lymphoma initiating treatment with vincristine
- •Planned minimum of 4 cycles of chemotherapy
- •Oxaliplatin-based regimens, Stage III colorectal cancer: Total of 6 months (planned minimum of 12 cycles). May consider Stage IV with minimal metastatic confirmed with Sponsor prior to enrollment
- •Bortezomib use in untreated multiple myeloma: Total of 4 months (planned minimum of 9 cycles)
- •Written informed consent given
- •Enrollment must be completed prior to receiving the first dose of chemotherapy
排除标准
- •Patients meeting ANY of the following criteria are not eligible for participation:
- •Evidence of central nervous system metastases
- •Evidence of clinically significant peripheral neuropathy (CTCAE >2) as defined by patient report of frequent numbness or tingling in the hands or feet
- •Any uncontrolled serious illness or medical condition that would impact the conduct of the current study
- •Previous exposure to neurotoxic chemotherapy drugs
- •Pre-existing neurodegenerative disease (Parkinson's, Alzheimer's, Huntington's, etc.), neuromuscular disorder (multiple sclerosis, ALS, polio, hereditary neuromuscular disease) or history of stoke or history of traumatic brain injury
- •General anesthesia less than one month prior to the first dose of neurotoxic chemotherapy
结局指标
主要结局
Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy
时间窗: Through study completion, 2 years
Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy
次要结局
未报告次要终点