Peripheral Neuropathy Clinical Trials

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Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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 assessments will be conduicted and the results will be corrleated with patients' subjective ratings using the EORTC-QLQ-CIPN20, QLQ-C30, and CTCAE v5.0 grading . In addition, data from matched healthy controls and chemotherapy patients without CIPN will be collected and compared with those of CIPN patients. The findings of this study will contribute to the development of objective measures of functional limitations caused by CIPN and provide a valuable complement to patient-reported outcome obtained through validated questionnaires.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• \- 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

Locations
Other Locations
Austria
Institute of Physical Medicine and Rehabilitation, University Hospital Salzburg
RECRUITING
Salzburg
Contact Information
Primary
Florian Rieder, PhD
f.rieder@salk.at
00435725553182
Time Frame
Start Date: 2026-03-15
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 120
Treatments
CIPN patiients
CIPN
Healthy Controls
healthy
Chemotherapy patients without CIPN symptoms
Chemotherapy patients without CIPN symptoms
Related Therapeutic Areas
Sponsors
Leads: Paracelsus Medical University

This content was sourced from clinicaltrials.gov