Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy

NCT07315334 | Not Yet Recruiting

• 1 other identifier: UIPMR_CIPN
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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, we will conduct comprehensive functional assessments and correlate the results with patients' subjective ratings using the EORTC-QLQ-CIPN20, QLQ-C30, and CTCAE v5.0 grading. In addition, data from matched healthy controls 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.

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Keywords

CIPN, EORTC CIPN20, gait , balance, functional assessment, 9 hole peg test,

Outcome Measures

Primary Outcomes (2)

• correlation between questionnaire data abd functional assessments

  correlation between questionnaire data abd functional assessments

  2 hours

• Correlations between questionnaire data and functional assessments

  2 hours

Secondary Outcomes (1)

• Group differences in functional assessments between CIPN patients and helathy controls

  2 hours

Study Arms (2)

CIPN patiients

CIPN

Diagnostic Test: Questionnaire and Physical Exam

Healthy Controls

healthy

Diagnostic Test: Questionnaire and Physical Exam

Interventions

Questionnaire and Physical Exam DIAGNOSTIC_TEST

Measurements: EORTC QLQ-CIPN 20 questionnaire, short physical performance test battery, gait and balance, 9 hole peg test, grip strength

CIPN patiients; Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CIPN patients from the paracleus medical university Healthy matched controls

You may qualify if:

• \- 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
• \- Male and female adults (age ≥ 18)
• \- Ability to stand and walk
• \- Ability to fill out a questionnaire

You may not qualify if:

• 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)

Sponsors & Collaborators

• Paracelsus Medical University: lead
• General Hospital Nuremberg & Paracelsus Medical University Nuremberg: collaborator

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Florian Rieder, PhD

CONTACT

00435725553182; f.rieder@salk.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.D.Dr. rer.nat.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share