Early Detection and Prevention of Neuropathy and Cognitive Impairment Following Treatment for Haematological Malignancies (the NOVIT Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in neuropathy assessed by change in the neurotoxicity (ntx)-subscale of the FACT/GOG-Ntx-13-Score
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, but not well understood complication to treatment with chemotherapy. In this study the investigators will investigate a novel method for early detection of CIPN and compare it to other methods in patients treated for haematological cancers.
详细描述
Haematological malignancies can be treated with chemotherapy if the patient tolerates the treatment. However, many patients develop complications during treatment including chemotherapy-induced peripheral neuropathy (CIPN) and/or impaired memory. Even though it is a well-known complication, no gold standard for CIPN assessment is known. Besides chemotherapy reduction or cessation, there is so far no sufficient prevention or treatment, therefore early detection and intervention is crucial.
The main purpose of this study is to find a reliable test for chemotherapy-induced peripheral neuropathy (CIPN) in order to predict early signs of CIPN. All included patients has to be scheduled for treatment with vincristine, bortezomib or lenalidomide regardless of haematological malignancy. Neuropathy and cognitive impairment will be tested at baseline (prior to treatment with chemotherapy), before each treatment course, 1 month after treatment and finally 1 year after onset of chemotherapy. CIPN will be examined by different methods: Clinician-based assessment, objective neurophysiological parameters and patient-reported outcome. A novel test using Perception Threshold Tracking (PTT), developed at Aalborg University, is included in the study. The test investigates the nerve excitability in both large and small fiber nerve fibers using two different electrodes. Blood samples will be collected, stored, and analyzed for deficiencies correlated to neuropathy.
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
- •Men and women, age ≥ 18 years
- •Scheduled for treatment with Vincristine (R-CHOP, CHOP, R-CHOEP, CHOEP, R-CVP, CVP or simi-lar), Bortezomib (VCD, MPV, VRD or similar) or Lenalidomide (VRD, len-dex or similar) regardless of type of haematological malignancy
- •Not started chemotherapy treatment before enrollment (pretreatment with steroids is allowed)
- •Associated to Department of Haematology, Aalborg University Hospital during the project period
- •Signed informed consent form
- •Able to read and speak Danish
排除标准
- •Known vitamin B12 deficiency and treated with either oral or intramuscular vitamin B12 within the last year
- •Known neural damage or disease in the neural system (e.g. MS, Guillain-Barre etc.)
- •Known severe skin disease
- •Pregnancy or breastfeeding
- •Inability to understand or comply with instructions
结局指标
主要结局
Change in neuropathy assessed by change in the neurotoxicity (ntx)-subscale of the FACT/GOG-Ntx-13-Score
时间窗: 0-12 months
A patient questionnaire with focus on Quality of Life and neuropathy. Range 0-52 with higher score meaning better Quality of Life (less neuropathy). Neuropathy will be defined as a 10 % reduction in the Ntx-score
次要结局
- Change in the score for FACT/GOG-cog(0-12 months)
- Change in Quality of Life (The total FACT/GOG-Ntx-score)(0-12 months)
- Change in nerve excitability assessed by Perception Threshold Tracking(0-12 months)
- Change in VagusTM Test(0-12 months)
- Change in Bioimpendance(0-12 months)
- Change in The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)(0-12 months)
- Change in the Total Neuropathy Score-Clinical(0-12 months)
- Change in Montreal Cognitive Assessment (MoCA)(0-12 months)
- Change in vitamin B12-level in blood test(0-12 months)
研究者
Marianne Tang Severinsen
Consultant, Head of Research, Ass. Professor
Aalborg University Hospital
