Identification of Chemotherapy-induced Peripheral Neuropathy

NCT07148336 | Not Yet Recruiting

• 1 other identifier: NEURO-BREAC
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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 breast cancer survivors previously treated with taxane-based chemotherapy and adjuvant radiotherapy.

Conditions

Breast Cancer

Keywords

Breast cancer; Chemotherapy; Taxanes; Peripheral Neuropathy; Scoring System

Outcome Measures

Primary Outcomes (1)

• Number of participants with moderate to severe chemotherapy-induced peripheral neuropathy

  Chemotherapy-induced peripheral neuropathy will be assessed with a symptom-based scoring system supported by a neuropathy tracker.

  from enrollment to clinical examination at 1 week

Secondary Outcomes (1)

• Rate of patient satisfaction

  from enrollment to clinical examination at 1 week

Study Arms (1)

Breast cancer patients treated with taxane-base chemotherapy

EXPERIMENTAL

Patients who were previously treated with taxane-base chemotherapy and adjuvant radiotherapy for breast cancer and developed either no or moderate to severe chemotherapy-induced peripheral neuropathy

Other: Symptom-based scoring system

Interventions

Symptom-based scoring system OTHER

The patients will be asked to complete the self-evaluation of symptoms and signs of neuropathy using a Neuropathy Tracker that questions symptoms quality, severity and distribution and guide the user through a systematic evaluation of pin-prick from a needle and vibration from the mobile on successive levels from the toes to the knee on both legs. Finally, the extension force or both great toes will be self-assessed by the participant. The self-examination is based on the structure of the Utah Early Neuropathy Score.

Breast cancer patients treated with taxane-base chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• Zealand University Hospital: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Dirk Rades, Prof Dr med

  University of Lubeck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Rades, Prof Dr med

CONTACT

0049-451-500; dirk.rades@uksh.de

Maria K Streubel, Dr rer nat

CONTACT

0049-451-500; MariaKarolin.Streubel@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: mono-center prospective study

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share