Understanding and detecting nerve damage from paclitaxel in breast cancer patients
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 study is testing ways to find early signs of nerve damage in women with early-stage breast cancer who are getting chemotherapy with paclitaxel, while also looking at how their quality of life changes during treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Solna, Stockholm County) |
| Trial ID | NCT06052345 on ClinicalTrials.gov |
What this trial studies
This observational cohort study focuses on female patients with early-stage non-metastatic breast cancer who are receiving adjuvant chemotherapy with paclitaxel. It aims to identify risk factors for chemotherapy-induced polyneuropathy (CIPN) and to test neurophysiological methods for its early detection. Participants will undergo a series of evaluations, including nerve conduction studies and sensory tests, before, during, and after treatment, while also monitoring their quality of life and lifestyle changes. The study will utilize a lifestyle monitoring system to track patient outcomes over a year.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with newly diagnosed primary breast cancer who are set to receive paclitaxel as part of their treatment.
Not a fit: Patients with a history of neuropathy or those with conditions that could interfere with the study outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of nerve damage in breast cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have explored similar approaches to understanding CIPN, but this specific methodology and focus on lifestyle impacts is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Solna, Stockholm County
- Karolinska University Hospital — Solna, Stockholm County, Sweden (Recruiting)
Study contacts
- Principal investigator: Theodoros Foukakis, MD, PhD — Karolinska University Hospital
- Study coordinator: Theodoros Foukakis, MD,PhD
- Email: theodoros.foukakis@ki.se
- Phone: 0736896713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.