Status:
NOT_YET_RECRUITING
Identification of Chemotherapy-induced Peripheral Neuropathy
Lead Sponsor:
University Hospital Schleswig-Holstein
Collaborating Sponsors:
Zealand University Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The main goal of this trial is to identify the optimal cut-off score of a Scoring System to discriminate between moderate to severe chemotherapy-induced peripheral neuropathy (CIPN) and no CIPN in bre...
Detailed Description
Adjuvant radiotherapy is a standard procedure following breast-conserving surgery for non-metastatic breast cancer. Depending of the tumor stage and other risk factors, radiotherapy may be indicated a...
Eligibility Criteria
Inclusion
- Histologically proven breast cancer
- Previous treatment with taxane-based chemotherapy followed by adjuvant radiotherapy
- Moderate to severe or no CIPN according to the Utah Early Neuropathy Scale and the Total Neuropathy Score
- Female gender
- Age ≥18 years
- Written informed consent
- Capacity of the patient to consent
Exclusion
- Disease-related skin disorders of the lower extremities (e.g., related to skin infections, bullous dermatoses, dermatitis, papulo-squamous skin disorders, or urticaria/erythema)
- Pregnancy, Lactation
- Expected non-compliance
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT07148336
Start Date
November 1 2025
End Date
June 30 2026
Last Update
September 8 2025
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