on-interventional study to observe skin toxicities under a Docetaxel therapy in treatment of concomitant use of Lipikar Baume AP + ® (NIS LipiDoc)

• Conditions: L99.8; C61; C50; C16; C34; Other specified disorders of skin and subcutaneous tissue in diseases classified elsewhere; Malignant neoplasm of prostate; Malignant neoplasm of breast; Malignant neoplasm of stomach; Malignant neoplasm of bronchus and lung

• Registration Number: DRKS00010725
• Lead Sponsor: ORCA2 GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-18
• Study Completion: 2018-09-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Presence of an indication for docetaxel - containing infusion therapy according to the monitoring plan
- Age = 18
- Presentation of written consent of the patient data capture

Exclusion Criteria

- Pregnancy, lactation
- Patients with a docetaxel - intolerance
- Patients with an intolerance of Lipikar Baume AP + ® - application
- Patients in 3rd- or xth-line therapy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of cutaneous side effects according to Common Toxicity Criteria for Adverse Events (CTCAE, v.4.03) under guideline conform and indication according docetaxel therapy ORCAzwei

Secondary Outcome Measures

Name	Time	Method
Observation of the efficacy of docetaxel ORCAzwei - therapy, taking into account the different indications and the Disease status (adjuvant, 1st-, 2nd-line)<br><br>- Observation of tolerability and safety of docetaxel ORCAzwei - therapy<br><br>- Observation quality of life (Quality of Life) by Patient Benefit Index Skin (PBI-K) under the optional accompanying, supportive use of Lipikar Baume AP + ® considering the individual, temporal use of concomitant therapy