NCT07604441

Brief Summary

The main goal of this trial is to identify the optimal cut-off score of a Scoring System to discriminate between mild chemotherapy-induced peripheral neuropathy (CIPN) and no CIPN in breast cancer survivors previously treated with taxane-based chemotherapy and adjuvant radiotherapy.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Breast Cancer

Keywords

Breast cancerChemotherapyTaxanesChemotherapy-induced peripheral neuropathyScoring system

Outcome Measures

Primary Outcomes (1)

  • Number of participants with mild 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 (2)

  • Rate of patient satisfaction

    from enrollment to clinical examination at 1 week

  • Number of participants with mild chemotherapy-induced peripheral neuropathy according to the Utah Early Neuropathy Scale

    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 mild chemotherapy-induced peripheral neuropathy

Diagnostic Test: Symptom-based scoring system

Interventions

Symptom-based scoring systemDIAGNOSTIC_TEST

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

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven breast cancer
  • Previous treatment with taxane-based chemotherapy followed by adjuvant radiotherapy
  • Mild or no CIPN according to 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, University of Luebeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dirk Rades, Prof. Dr. med., FASTRO

    University of Luebeck, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Rades, Prof. Dr. med., FASTRO

CONTACT

0049-451500Dirk.Rades@uksh.de

Maria K Streubel, Dr. rer. nat.

CONTACT

0049-451500MariaKarolin.Streubel@uksh.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: mono-center prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)