Randomized controlled pilot study on the effect of combined vibration and sensorimotor training on persistent chemotherapy-induced polyneuropathy in cancer survivors

Phase 2

• Conditions: C00-C97; Malignant neoplasms

• Registration Number: DRKS00024514
• Lead Sponsor: niversitätsklinikum Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-04
• Study Completion: 2023-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Patients within follow-up after malignant cancer (all entities); completion of medical system therapy (chemotherapy) at least 6 months ago; patients with existing CIPN (anamnesis); age = = 18 years.

Exclusion Criteria

Palliative patients or patients with advanced cancer; patients undergoing acute cancer therapy; polyneuropathy of other etiologies (diabetes mellitus, alcohol abuse, etc.); medications that cause polyneuropathy; participation in another study involving exercise intervention; medical conditions that compromise patient safety or study feasibility.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of CIPN (EORTC-QLQ-CIPN20) baseline (week 0) versus post assessment (week 12)

Secondary Outcome Measures

Name	Time	Method
CIPN (Common Terminology Criteria for Adverse Events (CTCAE), Peripheral deep sensitivity (Tuning fork), Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), Numeric Rating Scale), coordinative performance (Single Leg Stance, Short Physical Performance Battery, SPPB), physical activity (Bewegungs- und Sportaktivität Fragebogen, BSA-Fragebogen), quality of life (EORTC-QLQ-C30), feasibility