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

• Conditions: C56; C50; C34; Malignant neoplasm of ovary; Malignant neoplasm of breast; Malignant neoplasm of bronchus and lung

• Registration Number: DRKS00008185
• Lead Sponsor: OMNICARE Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-28
• Study Completion: 2020-03-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 83

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

None

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
• Evaluation of neurotoxicity by the investigator by means of CTCAE criteria (version 4.0)<br>• Evaluation of adverse drug reactions of Paclitaxel Omnicare®