Non-interventional study to evaluate neurotoxicity under therapy with Paclitaxel Omnicare for patients with various tumor entities

Non-interventional study to evaluate neurotoxicity under therapy with Paclitaxel Omnicare for patients with various tumor entities - NEPAL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00008185

Enrollment

300

Registered

2015-04-28

Start date

2015-07-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C56 C50 C34

Interventions

Group 1: Patients treated with Paclitaxel Omnicare are asked to complete a questionnaire every 3 months under therapy and every 6 months after end of treatment. The questionnaire contains questions re

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male and female patients = 18 years 2. Diagnosis of tumor disease for which a chemotherapy with Paclitaxel Omnicare is indicated 3. Investigator's decision (independent of study participation) to treat the patient with Paclitaxel Omnicare® 4. Sufficient patient's compliance upon investigator's assessment 5. Written informed consent of the patient to retrospective and prospective pseudonomized documentation, to forwarding and analysis of the data and to access to the data within monitoring

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Evaluation of grade and duration of neurotoxicity for patients (every 3 months under therapy and every 6 months after end of treatment) under therapy with Paclitaxel Omnicare by means of a patient questionnaire (FACT-GOG-Ntx)	—

Secondary

Measure	Time frame
• Evaluation of neurotoxicity by the investigator by means of CTCAE criteria (version 4.0) • Evaluation of adverse drug reactions of Paclitaxel Omnicare®	—

Countries

Germany

Contacts

Public ContactCaroline Schneider

Institut Dr. Schauerte

caroline.schneider@dr-schauerte.de089/6418040

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026