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

NCT06052345 | Recruiting DMC

• 2 other identifiers: 2022-04453-01965231
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 patient's lifestyle and quality of life for up to 12 months after the initiation of treatment

Conditions

Breast Neoplasms; Breast Cancer; Early-stage Breast Cancer; Non-Metastatic Breast Carcinoma; Polyneuropathy Due to Drugs; Polyneuropathy; Drug; Chemotherapy-induced Peripheral Neuropathy; Quality of Life

Keywords

Paclitaxel-induced polyneuropathy; Antineoplastic Agents; Plant Alkaloids; Paclitaxel; Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (4)

• 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

  1 year

• Correlation of abnormal laboratory tests in baseline assessment with development/severity of CIPN

  1 year

• Correlation of parameters of NCS, temperature thresholds, and IENFD at baseline screening with development and severity of CIPN

  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

  1 year

Secondary Outcomes (4)

• Calculate and compare the false negative and false positive rate of CIPN in every used method during follow up

  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

  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

  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

  2 years

Study Arms (2)

CIPN group

Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)

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)

Device: Garmin smartwatch; Other: REBECCA Mobile application; Other: REBECCA PC plug-in

Interventions

Garmin smartwatch DEVICE

* 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)

CIPN group; No-CIPN group

REBECCA Mobile application OTHER

* 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)

CIPN group; No-CIPN group

REBECCA PC plug-in OTHER

* 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

CIPN group; No-CIPN group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theodoros Foukakis: lead
• Karolinska Institutet: collaborator
• Centre for Research and Technology Hellas (CERTH): collaborator

Study Sites (1)

Karolinska University Hospital

Solna, Stockholm County, 171 76, Sweden

RECRUITING

Related Links

• 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

Biospecimen

Retention: SAMPLES WITH DNA

Blood and skin samples will be taken in different timepoints of the study as described in the protocol. Specifically, from each patient at least 10 ml of blood will be collected and 2 skin samples (3 mm wide, 2-3 mm deep)

MeSH Terms

Conditions

Breast Neoplasms; Polyneuropathies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Theodoros Foukakis, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodoros Foukakis, MD,PhD

CONTACT

0736896713; theodoros.foukakis@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant, Associate Professor of Oncology

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: March 31, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

SE (1)