Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Lif… (NCT06052345) | Clinical Trial Compass
WithdrawnNot Applicable
Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
Stopped: No accrual
Sweden0Started 2024-03-31
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 1 year
2
Correlation of abnormal laboratory tests in baseline assessment with development/severity of CIPN
Timeframe: 1 year
3
Correlation of parameters of NCS, temperature thresholds, and IENFD at baseline screening with development and severity of CIPN
Timeframe: 1 year
4
Biochemical and metabolic abnormalities prior to paclitaxel treatment and their association with the development of CIPN