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Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy

Recruitingn/aAges 18 Years - anyAllParacelsus Medical University
NCT07315334 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Chemotherapy-induced peripheral neuropathy (CIPN) is a severe side effect of several anti-cancer agents. Typical symptoms include tingling and hypoesthesia in the fingertips and/or toes, which substantially impair patients' quality of life and independence. Providing effective, evidence-based treatments for CIPN remains a major challenge in clinical practice. In a recent randomized clinical trial, our group demonstrated the effectiveness of electrotherapy in reducing both sensory and motor symptoms, as assessed by the EORTC-QLQ-CIPN20 questionnaire and CIPN grading according to CTCAE. However, these findings were based exclusively on patients' subjective self-reports (EORTC QLQ CIPN 20 and C-30). To more objectively evaluate treatment success, functional assessments that capture impairments in daily activities are needed. In this cross-sectional comparison, comprehensive functional asse

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📋 Eligibility rules (as published)
Inclusion Criteria: \- Male and female patients with CIPN grade ≥ 2, according to Common Terminology Criteria for Adverse Events for peripheral sensory or motor neuropathy (CTCAE) version 5 \- Age ≥ 18 \- Ongoing or completed neuropathy-inducing chemotherapy \- Ability to stand and walk \- Ability to fill out a questionnaire Inclusion criteria for healthy controls \- Male and female adults (age ≥ 18) \- Ability to stand and walk \- Ability to fill out a questionnaire Exclusion Criteria: * Pre-existing clinically manifest peripheral neuropathy prior to start of chemotherapy (e.g. caused by radiation or malignant plexopathy, lumbar or cervical radiculopathy, carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) Acute or chronic injuries/ diseases of the musculoskeletal system affecting functional tests \- Acute or chronic cardiovascular diseases affecting functional tests \- Neurological disease affecting functional tests (for healthy controls) \- Neurological disease other than CIPN affecting functional tests (for CIPN patients)
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What it tests

  • Questionnaire and Physical Exam
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Where

1 site
Institute of Physical Medicine and Rehabilitation, University Hospital Salzburg
Salzburg, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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