Chemotherapy induced peripheral neuropathy outcome measures standardisation study

Completed

• Conditions: peripheral nerve lesion; polyneuropathy; 10034606

• Registration Number: NL-OMON32417
• Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Subjects must have CIPN and be available for study at a participating centre. CIPN is defined as having symptoms, signs and/or test results that in the opinion of the Investigator are typical of a toxic polyneuropathy due to the subject*s chemotherapy.
2. Male and female subjects who are 18 years of age or older.
3. Subjects must give informed consent by signing and dating an informed consent form prior to study entry.
4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.
5. Subjects must have a stable clinical condition. A clinical stable condition is defined as either an unchanged clinical functionality as declared by the subject to the best of his/her knowledge over 1 month prior to the study or no clear objective changes at neurological examination by the researcher when compared with recorded findings over two month prior to study entry (if available).
6. Each subject will receive an information leaflet and an informed consent form. A common version will be prepared in English and translated by each investigator in its own language.
7. Subjects must have a Karnofsky performance score greater than or equal to 70.

Exclusion Criteria

Subjects presenting with any of the following will not be included in the trial:
1. Active underlying malignancy and poor prognosis.
2. Chemotherapy is planned while the subject is in this study.
3. Concomitant diseases e.g., diabetes, renal insufficiency, alcohol abuse (more than 5 IU/day) that would interfere or complicate the assessments.
4. Concomitant neurologic conditions, e.g., brain tumor, spinal or brain metastases that would interfere or complicate the assessments.
5. Severe depression that in the opinion of the Investigator would complicate the assessments.
6. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached.
7. Subjects with a known presence of peripheral nerve damage due to another illness or medication.
8. Subjects who are currently receiving another medication that has known potential to produce neurologic peripheral nerve toxicity, (e.g. metrodiazole or isoniazid).
9. Subjects with any other condition, which, in the investigator*s judgment might decrease the chance of obtaining satisfactory data to achieve the objectives of the study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endpoints: The primary endpoint for this study is to determine the validity and<br /><br>reproducibility of the proposed outcome measures in chemotherapy-induced<br /><br>peripheral neuropathy.<br /><br><br /><br>Trial Treatments: There are no trial-specified treatments as subjects will<br /><br>receive only their usual medical care which must be stable during this study.<br /><br>The investigators will not influence decisions regarding treatment duration nor<br /><br>supply medication for this study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>