Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorParacelsus Medical University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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.)

Trial population

CIPN patients from the paracleus medical university Healthy matched controls

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: CIPN patiients1 intervention
Group B: Healthy Controls1 intervention
Group C: Chemotherapy patients without CIPN symptoms1 intervention

Trial outcomes

Primary outcomes

1

correlation between questionnaire data abd functional assessments

correlation between questionnaire data abd functional assessments

Time frame
2 hours
2

Correlations between questionnaire data and functional assessments

Time frame
2 hours

Secondary outcomes

1

Group differences in functional assessments between CIPN patients and helathy controls

Group differences in functional assessments between CIPN patients and helathy controls

Time frame
2 hours

Other outcomes

Sponsors and contacts

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