Multicenter, non-interventional, prospective observational study to investigate the local treatment of chemotherapy-induced peripheral neuropathy with QUTENZA in breast cancer patients
Recruiting
- Conditions
- G62.0Drug-induced polyneuropathy
- Registration Number
- DRKS00022442
- Lead Sponsor
- Grünenthal GmbH German Sales Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 77
Inclusion Criteria
Painful CIPN after taxane and/or platinum derivative therapy for breast cancer; patients after neoadjuvant/adjuvant chemotherapy; Qutenza-naive patients; painDETECT Score =13 during inclusion phase; intact, non-irritated, dry skin in the painful area to be treated; ability to give consent; written declaration of consent by the patient after clarification
Exclusion Criteria
Patients under palliative chemotherapy; pregnancy; contraindications according to the QUTENZA professional information; peripheral polyneuropathies of other genesis (not CIPN-related, e.g. diabetes, HIV, alcohol abuse); insufficient knowledge of German language
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main objective is the reduction of neuropathic pain, including neuropathic pain symptoms, determined by the painDETECT questionnaire. In order to be able to determine significant differences between the survey points in time, one-sample t-tests for mean equality are used for connected samples.
- Secondary Outcome Measures
Name Time Method CIPN-specific quality of life (change in QLQ-CIPN20); pain reduction (absolute value on the NRS); health-related quality of life (EQ-5D-3L); satisfaction with the therapy; reduction of the accompanying pain medication; size of the painful area; intervals between treatments; compatibility; costs