Assessment of the responsiveness of the Rasch-built, CIPN-specific questionnaire (CIPN-RODS) to clinical changes in patients undergoing neurotoxic chemotherapy.
- Conditions
- chemotherapy-induced polyneuropathy1002765610034606
- Registration Number
- NL-OMON42804
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
1. Subjects must be candidates for chemotherapy including in the treatment plan platinum-based drugs or taxanes at doses expected to be potentially neurotoxic
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 have a Karnofsky performance score greater than or equal to 70.
1. Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.
2. Concomitant neurologic conditions, e.g., brain tumor, spinal or brain metastases.
3. Severe depression that in the opinion of the Investigator would complicate the assessments.
4. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.
5. Subjects with a known presence of peripheral nerve damage due to another illness or medication.
6. Subjects who are currently receiving another medication that has known potential to produce neurologic peripheral nerve toxicity (e.g. metrodiazole or isoniazid).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method