Multicenter, non-interventional, prospective observational study to investigate the local treatment of chemotherapy-induced peripheral neuropathy with QUTENZA in breast cancer patients

Multicenter, non-interventional, prospective observational study to investigate the local treatment of chemotherapy-induced peripheral neuropathy with QUTENZA in breast cancer patients - QUCIP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00022442

Enrollment

Registered

2020-07-28

Start date

2020-08-20

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

G62.0

Interventions

Group 1: In patients with chemotherapy-induced peripheral neuropathy after breast cancer, neuropathic pain, including neuropathic pain symptoms, is investigated using the painDETECT questionnaire when

Eligibility

Sex/Gender

Female

Age

18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Germany

Contacts

Public ContactHelena Thiem

Institut für Empirische Gesundheitsökonomie

helena.thiem@ifeg.de02174715126

Outcome results

None listed

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