Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
NCT ID: NCT06052345
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-03-31
2026-12-31
Brief Summary
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* 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
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CIPN group
Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
Garmin smartwatch
* Physical activity (Activity sessions, type and length of activity, activity intensity estimations)
* Meal detection and meal characteristics (accelerometry and gyroscope data)
* Oxygen saturation (pulse oximetry)
* Number of steps (pedometer)
* Stress level indicators (based on heart-rate analytics)
* Sleep patterns (sleep and wake-up time, sleep quality)
REBECCA Mobile application
* GPS positioning (daily location change patterns through pathway analysis and Point-of-interest analysis based on type-of-location automatic detection)
* Self-reports from patients and companions reports on mental and physical health, as well as periodic quality of life evaluations3
* Patient self-uploaded pictures of meals (for evaluation of nutritional habits) and living environment stressors (for evaluation of living environment and self-perceived stressor analysis)
REBECCA PC plug-in
* the developed plug-in monitors online activity, collecting anonymized data from web-browsers (Chrome) and social media (Facebook, Youtube and Instagram).
* These are relevant to current and historical data on: i) keywords in searches, ii) types of websites visited, iii) reactions to posts, iv) participation in online groups, v) types of bookmarked websites
No-CIPN group
Breast cancer patients that developed mild-to-no CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
Garmin smartwatch
* Physical activity (Activity sessions, type and length of activity, activity intensity estimations)
* Meal detection and meal characteristics (accelerometry and gyroscope data)
* Oxygen saturation (pulse oximetry)
* Number of steps (pedometer)
* Stress level indicators (based on heart-rate analytics)
* Sleep patterns (sleep and wake-up time, sleep quality)
REBECCA Mobile application
* GPS positioning (daily location change patterns through pathway analysis and Point-of-interest analysis based on type-of-location automatic detection)
* Self-reports from patients and companions reports on mental and physical health, as well as periodic quality of life evaluations3
* Patient self-uploaded pictures of meals (for evaluation of nutritional habits) and living environment stressors (for evaluation of living environment and self-perceived stressor analysis)
REBECCA PC plug-in
* the developed plug-in monitors online activity, collecting anonymized data from web-browsers (Chrome) and social media (Facebook, Youtube and Instagram).
* These are relevant to current and historical data on: i) keywords in searches, ii) types of websites visited, iii) reactions to posts, iv) participation in online groups, v) types of bookmarked websites
Interventions
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Garmin smartwatch
* Physical activity (Activity sessions, type and length of activity, activity intensity estimations)
* Meal detection and meal characteristics (accelerometry and gyroscope data)
* Oxygen saturation (pulse oximetry)
* Number of steps (pedometer)
* Stress level indicators (based on heart-rate analytics)
* Sleep patterns (sleep and wake-up time, sleep quality)
REBECCA Mobile application
* GPS positioning (daily location change patterns through pathway analysis and Point-of-interest analysis based on type-of-location automatic detection)
* Self-reports from patients and companions reports on mental and physical health, as well as periodic quality of life evaluations3
* Patient self-uploaded pictures of meals (for evaluation of nutritional habits) and living environment stressors (for evaluation of living environment and self-perceived stressor analysis)
REBECCA PC plug-in
* the developed plug-in monitors online activity, collecting anonymized data from web-browsers (Chrome) and social media (Facebook, Youtube and Instagram).
* These are relevant to current and historical data on: i) keywords in searches, ii) types of websites visited, iii) reactions to posts, iv) participation in online groups, v) types of bookmarked websites
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Karolinska Institutet
OTHER
Centre for Research and Technology Hellas (CERTH)
UNKNOWN
Theodoros Foukakis
OTHER
Responsible Party
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Theodoros Foukakis
Senior Consultant, Associate Professor of Oncology
Principal Investigators
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Theodoros Foukakis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Locations
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Karolinska University Hospital
Solna, Stockholm County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Theodoros Foukakis, MD,PhD
Role: primary
Kaveh Pourhamidi, MD,PhD
Role: backup
Dimitrios Avramidis, MD
Role: backup
Maria Angeliki Toli, MD
Role: backup
Related Links
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REBECCA stands for REsearch on BrEast Cancer induced chronic conditions supported by Causal Analysis of multi-source data and aims to tap into the potential of Real-World Data to support clinical research and to improve existing clinical work
Other Identifiers
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965231
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022-04453-01
Identifier Type: -
Identifier Source: org_study_id
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