Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06052345
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-09-18
Brief Title:
Paclitaxel-induced Polyneuropathy in Breast Cancer Early Detection Risk Factors Quality of Life and Lifestyle Outcomes
Sponsor:
Theodoros Foukakis
Organization:
Karolinska University Hospital
Study Overview
Official Title:
ChemotherapyPaclitaxel-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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIPN-REBECCA
Brief Summary:
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 patients lifestyle and quality of life for up to 12 months after the initiation of treatment
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 patients lifestyle and quality of life for up to 12 months after the initiation of treatment
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 965231 | OTHER_GRANT | European Unions Horizon 2020 research and innovation programme | None |