Chemotherapy(Paclitaxel)-Induced Polyneuropathy in Breast Cancer as Part of the REBECCA Project (REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation of parameters of NCS, temperature thresholds, and IENFD at baseline screening with development and severity of CIPN
研究概览
简要总结
This is a single center prospective observational cohort study that aims to:
- examine and identify possible risk and susceptibility factors for the incidence and progression of chemotherapy-induced polyneuropathy (CIPN) in female patients primarily operated for early non-metastatic breast cancer who will receive adjuvant chemotherapy containing paclitaxel
- test different neurophysiological methods for early detection of CIPN
- explore changes that underlie the development of CIPN in relation to clinical presentations, neurophysiological assessment, including measures of small nerve fiber dysfunction, and possible biochemical, metabolic and genetic associations
- explore the effects of CIPN in the patient's lifestyle and quality of life for up to 12 months after the initiation of treatment
详细描述
The patients who follow the inclusion criteria of the study will be asked to complete:
- a baseline evaluation prior to receiving treatment. This will include a bedside clinical-neurological evaluation, nerve conduction studies (NCS) and quantitative sensory tests of thermal threshold (QST), blood sampling, an oral glucose tolerance test, a skin biopsy, and answering of questionnaires for assessment of symptoms of peripheral neuropathy as well as self-reports on their pre-treatment health and lifestyle status and cancer specific symptomatology
- an on-treatment evaluation 4 weeks after the start of the treatment which will include NCS and QST
- a post-treatment evaluation 4 weeks after the end of treatment which will include the evaluations stated above. During this visit the participants will be provided with the REBECCA lifestyle monitoring system which will include a smartwatch, installation of a mobile app and a PC plugin. The patients will be also asked to fill in some self-rated evaluations as in the pre-treatment period. Researchers, based on the outcomes of the participants, will divide them in two study groups A. CIPN-group and B. No CIPN which will be monitored with the REBECCA monitoring system.
- a final evaluation. This will be performed 8 months after the post-treatment evaluation and it will include clinical-neurological evaluation, nerve conduction studies (NCS) and thermal threshold testing (QST). Additionally, the participants will be requested to fill in the same self-rated evaluations as in the baseline and the post-treatment.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Age of ≥ 18 years
- •Newly operated primary breast cancer without metastatic disease receiving adjuvant chemotherapy containing paclitaxel
- •No prior chemotherapy other than cyclophosphamide and epirubicin
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Written informed consent
- •Able to communicate with investigators, participate in testing and comply with the requirements of the study-protocol
排除标准
- •Have received drugs suspected/known to cause peripheral neuropathy
- •Have history of acquired or inherited neuropathy or other genetic disease with increased tendency to develop neuropathy
- •Have known disturbed glucose metabolism, either diabetes mellitus or impaired glucose tolerance
- •Have moderate to severe kidney, liver, lung or heart disease
- •Have known symptomatic or other advanced spinal stenosis
- •Have known autoimmune disease that potentially cause or contribute to neuropathy
- •Have known HIV or active HBV or HCV infections
- •Have known paraneoplastic syndrome
- •Have known alcohol abuse
- •Have known pregnancy or nursing
研究组 & 干预措施
CIPN group
Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
干预措施: Garmin smartwatch (Device)
CIPN group
Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
干预措施: REBECCA Mobile application (Other)
CIPN group
Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
干预措施: REBECCA PC plug-in (Other)
No-CIPN group
Breast cancer patients that developed mild-to-no CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
干预措施: Garmin smartwatch (Device)
No-CIPN group
Breast cancer patients that developed mild-to-no CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
干预措施: REBECCA Mobile application (Other)
No-CIPN group
Breast cancer patients that developed mild-to-no CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
干预措施: REBECCA PC plug-in (Other)
结局指标
主要结局
Correlation of parameters of NCS, temperature thresholds, and IENFD at baseline screening with development and severity of CIPN
时间窗: 1 year
Correlation of significant deterioration in neurophysiological parameters including alterations in morphology of small fibers or reduced IENFD (Intraepidermal Nerve Fiber Density) on first follow up visit and development of CIPN
时间窗: 1 year
by performing detailed clinical neurophysiological examination and skin biopsies (where IENFD will be quantified) in different timepoints as described in the study protocol
Correlation of abnormal laboratory tests in baseline assessment with development/severity of CIPN
时间窗: 1 year
Biochemical and metabolic abnormalities prior to paclitaxel treatment and their association with the development of CIPN
时间窗: 1 year
by performing blood tests, genotyping and skin biopsies
次要结局
- Study any correspondence between deterioration of QoL indicated by REBECCA monitoring system and standardized patient self-reported measures with diagnosed CIPN after implementation of different methods during follow up(2 years)
- Association of altered scoring in different questionnaires (Fact/GOG-Ntx, SFN-SIQ) and different examinations (UENS) with the presence and severity of CIPN(1 year)
- Calculate and compare the false negative and false positive rate of CIPN in every used method during follow up(1 year)
- Evaluation of whether specific genotypes of breast cancer and higher or lower levels of different proteins are related with higher incidence rate and severity of CIPN(2 years)
研究者
Theodoros Foukakis
Senior Consultant, Associate Professor of Oncology
Karolinska University Hospital