Chemotherapy-induced Peripheral NeuropathyNCT04773379
Validation of the PNQ for CIPN Patients.
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2019to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 male or female patients from the oncology clinic of the General Hospital of Rhodes, Greece, regardless of cancer type
Who may be able to join
- Patients older than 18 and under 80 years of age
- Patients that undergo chemotherapy for the first time
- Patients regardless of cancer type
- Patients regardless of social and education underground
- Patients able to communicate with personnel
Who cannot join
- Pediatric patients
- Preexisting neurological condition
- Patients already under chemotherapy treatment
- Patients unable to communicate with personnel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Patient Neurotoxicity Questionnaire for Patients Suffering From Chemotherapy Induced Peripheral Neuropathy in Greek.
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.
Read more
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.
- Keywords
- chemotherapy, peripheral neuropathy, questionnaire
- Medical subject headings
- Peripheral Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in CIPN symptoms on the PNQ at the 2nd chemotherapy treatment session.
The PNQ is a self reported instrument assessing CIPN symptoms (sensory and motor) over time. Possible scores range from A(none) to E(severe).
Measured: Baseline (1st chemotherapy treatment session) and up to 1 month (2nd chemotherapy treatment session).
Change from the 2nd chemotherapy treatment session in CIPN symptoms on the PNQ at the 4th chemotherapy treatment session.
The PNQ is a self reported instrument assessing CIPN symptoms (sensory and motor) over time. Possible scores range from A(none) to E(severe).
Measured: 2nd chemotherapy treatment session and up to 2 months (4th chemotherapy treatment session).
Change from the 4th chemotherapy treatment session in CIPN symptoms on the PNQ at the 6th chemotherapy treatment session.
The PNQ is a self reported instrument assessing CIPN symptoms (sensory and motor) over time. Possible scores range from A(none) to E(severe).
Measured: 4th chemotherapy treatment session and up to 2 months (6th chemotherapy treatment session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Apr 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theofilos Tsoleridis, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773379
- Sponsor's protocol ID
- DUThrace
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Patient Neurotoxicity Questionnaire for Patients Suffering From Chemotherapy Induced Peripheral Neuropathy in Greek.
- ClinicalTrials.gov ID
- NCT04773379
- Acronym / sponsor ID
- DUThrace
- Keywords
- chemotherapy, peripheral neuropathy, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 male or female patients from the oncology clinic of the General Hospital of Rhodes, Greece, regardless of cancer type
Key inclusion criteria (5 listed)
- Patients older than 18 and under 80 years of age
- Patients that undergo chemotherapy for the first time
- Patients regardless of cancer type
- Patients regardless of social and education underground
- Patients able to communicate with personnel
Key exclusion criteria (4 listed)
- Pediatric patients
- Preexisting neurological condition
- Patients already under chemotherapy treatment
- Patients unable to communicate with personnel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in CIPN symptoms on the PNQ at the 2nd chemotherapy treatment session.
Time frame: Baseline (1st chemotherapy treatment session) and up to 1 month (2nd chemotherapy treatment session).
The PNQ is a self reported instrument assessing CIPN symptoms (sensory and motor) over time. Possible scores range from A(none) to E(severe).
Change from the 2nd chemotherapy treatment session in CIPN symptoms on the PNQ at the 4th chemotherapy treatment session.
Time frame: 2nd chemotherapy treatment session and up to 2 months (4th chemotherapy treatment session).
The PNQ is a self reported instrument assessing CIPN symptoms (sensory and motor) over time. Possible scores range from A(none) to E(severe).
Change from the 4th chemotherapy treatment session in CIPN symptoms on the PNQ at the 6th chemotherapy treatment session.
Time frame: 4th chemotherapy treatment session and up to 2 months (6th chemotherapy treatment session).
The PNQ is a self reported instrument assessing CIPN symptoms (sensory and motor) over time. Possible scores range from A(none) to E(severe).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Democritus University of Thrace at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in CIPN symptoms on the PNQ at the 2nd chemotherapy treatment session. (time frame: Baseline (1st chemotherapy treatment session) and up to 1 month (2nd chemotherapy treatment session).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.