NCT04773379

Validation of the PNQ for CIPN Patients.

Completed Last updated 26 February 2021

What this trial tests

trial in Chemotherapy-induced Peripheral Neuropathy in 100 participants. Completed in 31 October 2020.

Timeline

1 April 2019

Primary endpoint
31 October 2020

31 October 2020

Quick facts

Lead sponsor	Democritus University of Thrace
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 April 2019
Primary completion	31 October 2020
Estimated completion	31 October 2020
Sites	1 location across Greece

Conditions studied

• Chemotherapy-induced Peripheral Neuropathy — all drugs for Chemotherapy-induced Peripheral Neuropathy →

Sponsor

Democritus University of Thrace

Who can join

Adults 18 to 80, any sex, with Chemotherapy-induced Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Patient Neurotoxicity Questionnaire (PNQ) represents a diagnostic tool concerning patients with Chemotherapy Induced Peripheral Neuropathy (CIPN). Application of such a tool in the Greek clinical praxis requires validation.

Validation consists of three stages: translation, reverse translation, and patient application. 100 oncologic patients were assessed by comparing the PNQ to the NCI-CTCAE at the chemotherapy onset and 2nd, 4th, and 6th sessions. Specific requirements of the diagnostic tool (compliance, validity, concordance, sensitivity, specificity, reliability) were statistically evaluated.

Differences between translated texts and between the reverse translation and the original were considered negligible. At the 2nd, 4th and 6th session compliance was 98%, 95% and 93% while Cronbach's α was 0,57 0,69 and 0,81 respectively. Cohen's weighted κ was 0,67 and 0,58, Spearman's ρ was 0,7 and 0,98 while AUC of the ROC was 1 and 0,9 for the sensory and the motor part respectively. The variance's linear regression analysis confirmed CIPN worsening over time (p-value\<0,0001).

The Greek version remains close to the original. Compliance rates reflect easy PNQ application. Cohen's κ values highlight the physicians' tension to underestimate the patients' condition. Spearman's ρ, Cronbach's α and AUC values reflect good validity, reliability and specificity of the PNQ respectively. Finally, the linear analysis confirmed the PNQ sensitivity over time.

The PNQ validation in Greek adds a crucial tool in the physicians' armory. It can now draw the necessary information to modify the chemotherapy and analgesic treatment schemes at both preventive and acute levels.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Validation of the Patient Neurotoxicity Questionnaire for Patients Suffering From Chemotherapy-Induced Peripheral Neuropathy in Greek.
   Tsoleridis T, Chloropoulou P, Tsaroucha A, Vadalouca A, et al · · 2021 · cited 6× · PMID 33842180 · DOI 10.7759/cureus.14324