Breast NeoplasmsCIPN-REBECCANCT06052345
Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
An observational study of Breast Neoplasms and Breast Cancer, run by Theodoros Foukakis at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Cancer, Early-stage Breast Cancer
- What is being tested?
- Garmin smartwatch, REBECCA Mobile application and REBECCA PC plug-in
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Have known HIV or active HBV or HCV infections
- Have known paraneoplastic syndrome
- Have known alcohol abuse
- Have known pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Breast Neoplasms, Breast Cancer, Early-stage Breast Cancer, Non-Metastatic Breast Carcinoma, Polyneuropathy Due to Drugs, Polyneuropathy; Drug
- Being tested
- Garmin smartwatch, REBECCA Mobile application, REBECCA PC plug-in
- Keywords
- Paclitaxel-induced polyneuropathy, Antineoplastic Agents, Plant Alkaloids, Paclitaxel, Adjuvant Chemotherapy
- Medical subject headings
- Breast Neoplasms, Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garmin smartwatchDevice
- 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 applicationOther
- 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-inOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| CIPN group | Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy) Receives: Device: Garmin smartwatch; Other: REBECCA Mobile application; Other: REBECCA PC plug-in | |
| No-CIPN group | Breast cancer patients that developed mild-to-no CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy) Receives: Device: Garmin smartwatch; Other: REBECCA Mobile application; Other: REBECCA PC plug-in |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
by performing detailed clinical neurophysiological examination and skin biopsies (where IENFD will be quantified) in different timepoints as described in the study protocol
Measured: 1 year
Correlation of abnormal laboratory tests in baseline assessment with development/severity of CIPN
Measured: 1 year
Correlation of parameters of NCS, temperature thresholds, and IENFD at baseline screening with development and severity of CIPN
Measured: 1 year
Biochemical and metabolic abnormalities prior to paclitaxel treatment and their association with the development of CIPN
by performing blood tests, genotyping and skin biopsies
Measured: 1 year
Secondary outcomes (4)
Calculate and compare the false negative and false positive rate of CIPN in every used method during follow up
Measured: 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
Measured: 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
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.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start31 Mar 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: No accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodoros Foukakis
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Centre for Research and Technology Hellas
- Responsible party
- Sponsor-investigator, Theodoros Foukakis, Karolinska University Hospital
- Investigators
- Theodoros Foukakis, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052345
- Sponsor's protocol ID
- 2022-04453-01
- Other IDs
- 965231
- Acronym
- CIPN-REBECCA
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06052345
- Acronym / sponsor ID
- CIPN-REBECCA / 2022-04453-01
- Conditions
- Breast Neoplasms, Breast Cancer, Early-stage Breast Cancer, Non-Metastatic Breast Carcinoma, Polyneuropathy Due to Drugs, Polyneuropathy; Drug
- Keywords
- Paclitaxel-induced polyneuropathy, Antineoplastic Agents, Plant Alkaloids, Paclitaxel, Adjuvant Chemotherapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Theodoros FoukakisUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Centre for Research and Technology Hellas
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIPN group | – | Device: Garmin smartwatch, Other: REBECCA Mobile application, Other: REBECCA PC plug-inBreast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy) |
| No-CIPN group | – | Device: Garmin smartwatch, Other: REBECCA Mobile application, Other: REBECCA PC plug-inBreast cancer patients that developed mild-to-no CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | CIPN group, No-CIPN group |
| 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 | CIPN group, No-CIPN group |
| 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 | Other | CIPN group, No-CIPN group |
Primary outcome
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
Correlation of abnormal laboratory tests in baseline assessment with development/severity of CIPN
Time frame: 1 year
Correlation of parameters of NCS, temperature thresholds, and IENFD at baseline screening with development and severity of CIPN
Time frame: 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
4 secondary outcomes
Calculate and compare the false negative and false positive rate of CIPN in every used method during follow up
Time frame: 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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- 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 workLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodoros Foukakis, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Breast Cancer, run by Theodoros Foukakis at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.