Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes (CIPN-REBECCA)

Theodoros Foukakis

Status

Enrolling

Conditions

Polyneuropathy Due to Drugs

Breast Cancer

Chemotherapy-induced Peripheral Neuropathy

Quality of Life

Early-stage Breast Cancer

Non-Metastatic Breast Carcinoma

Breast Neoplasms

Polyneuropathy; Drug

Treatments

Other: REBECCA PC plug-in

Other: REBECCA Mobile application

Device: Garmin smartwatch

Study type

Observational

Funder types

Other

Identifiers

965231 (Other Grant/Funding Number)

2022-04453-01

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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