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

August 12, 2026 updated by: Theodoros Foukakis

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
    • Stockholm County
      • Solna, Stockholm County, Sweden, 171 76
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be identified as potential candidates and consecutively recruited from the oncology clinic at Karolinska University Hospital in Solna. Eligible candidates are patients who have been primarily operated for early non-metastatic breast cancer and are recommended by the multidisciplinary conference to receive adjuvant chemotherapy containing paclitaxel.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CIPN group
Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
Device: 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)
Other: 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)
Other: 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)
Device: 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)
Other: 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)
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
1 year
Correlation of abnormal laboratory tests in baseline assessment with development/severity of CIPN
Time Frame: 1 year
1 year
Correlation of parameters of NCS, temperature thresholds, and IENFD at baseline screening with development and severity of CIPN
Time Frame: 1 year
1 year
Biochemical and metabolic abnormalities prior to paclitaxel treatment and their association with the development of CIPN
Time Frame: 1 year
by performing blood tests, genotyping and skin biopsies
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Calculate and compare the false negative and false positive rate of CIPN in every used method during follow up
Time Frame: 1 year
1 year
Association of altered scoring in different questionnaires (Fact/GOG-Ntx, SFN-SIQ) and different examinations (UENS) with the presence and severity of CIPN
Time Frame: 1 year
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
Time Frame: 2 years
by extracting DNA from blood samples and performing subsequent genotyping using SNP-array and GWAS. Also, by using proteomics analysis in blood samples and measure plasma levels of different proteins.
2 years
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
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theodoros Foukakis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet
Centre for Research and Technology Hellas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Theodoros Foukakis, MD, PhD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-04453-01
  • 965231 (Other Grant/Funding Number: European Union's Horizon 2020 research and innovation programme)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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