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Chemotherapy-Induced Peripheral Neuropathy - Additional Evaluation in Breast Cancer Survivors

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital Schleswig-Holstein

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Symptom-based scoring system

    Diagnostic 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.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Breast cancer patients treated with taxane-base chemotherapyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
from enrollment to clinical examination at 1 week

Secondary outcomes

1

Rate of patient satisfaction

Patient satisfaction with the symptom-based scoring system ranging from 0 to 44 points (higher scores represent a higher grade of peripheral neuropathy) will be assessed using a specific questionnaire.

Time frame
from enrollment to clinical examination at 1 week
2

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

Chemotherapy-induced peripheral neuropathy will be assessed with a symptom-based scoring system using the Utah Early Neuropathy Scale.

Time frame
from enrollment to clinical examination at 1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Schleswig-Holstein

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: