Self-Assessment of Neuropathic Symptoms Following Taxane-Based Chemotherapy for Breast Cancer
- Gender
- Women
- Age
- 18 years and older
- Trial type
- Interventional
- Line of therapy
- all
- Phase
- —
What is this trial about?
Breast cancer is often treated with chemotherapy that contains active ingredients from the taxane class, which can damage peripheral nerves (chemotherapy-induced peripheral neuropathy). The goal of the NEURO-BREAC-02 study is to investigate a method that allows patients to self-assess their nerve symptoms. Patients aged 18 and older with breast cancer who have previously received chemotherapy with taxanes followed by adjuvant radiation therapy are eligible to participate in this study.
Trial flow
Requirements
Diagnosis: breast cancer
Age: 18 years and older
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: women; completed chemotherapy with taxanes followed by adjuvant radiation therapy; with no or only mild chemotherapy-induced peripheral neuropathy (CIPN)
Allocation
Einarmige Studie
Treatment
Follow-up
Diagnosis: breast cancer
Age: 18 years and older
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: women; completed chemotherapy with taxanes followed by adjuvant radiation therapy; with no or only mild chemotherapy-induced peripheral neuropathy (CIPN)
Einarmige Studie
Detailed description
Breast cancer (mammary carcinoma) is a malignant disease of the breast tissue characterized by the uncontrolled proliferation of breast cells. Depending on the stage of the disease, treatment may include surgery, radiation therapy, and drug therapies. Many patients also receive chemotherapy before or after surgery, which often includes taxanes such as paclitaxel or docetaxel. These active ingredients stabilize the microtubules—fine tubes in the cell’s cytoskeleton that are necessary for cell division. As a result, rapidly dividing cells—such as cancer cells—can no longer divide properly. The microtubules also transport building blocks and signaling molecules within the long nerve fibers, which is why taxanes can damage the peripheral nerves. As a result, chemotherapy-induced peripheral neuropathy (CIPN) may occur, which usually first manifests in the toes and feet as well as the fingers and hands through tingling, numbness, altered sensation, or pain, and can be very distressing. Exactly how it develops has not yet been conclusively clarified scientifically. No effective prevention is known to date, and treatment options for existing neuropathy are limited, which is why early detection of initial signs is crucial. The aim of this study is to investigate a method that allows patients to self-assess their nerve symptoms. A so-called neuropathy tracker is used to assess the type, severity, and distribution of the symptoms. Patients then test their sensitivity to a pinprick sensation and vibration on both legs, from the toes to the knee. The Neuropathy Tracker guides the patients through this process; the vibration is generated using a cell phone. Finally, the extension strength of both big toes is tested. The data is used to calculate a score, and the study examines the threshold at which mild CIPN can best be distinguished from the absence of neuropathy. There is a single study group, and the study is open-label (not blinded), meaning that both the patients and the study physicians know which procedure is being used. Eligible participants are women aged 18 and older with breast cancer who have previously received taxane-based chemotherapy followed by adjuvant radiation therapy and who have no CIPN or only mild CIPN. Women with skin conditions on their legs, as well as those who are pregnant or breastfeeding, are ineligible to participate.
Facts
- Disease: Breast cancer (mammary carcinoma)
- Cancer characteristics: Following completion of chemotherapy with taxanes and subsequent adjuvant radiation therapy, with no or only mild chemotherapy-induced peripheral neuropathy (CIPN)
- What the study investigates: an assessment system that allows patients to self-report symptoms and signs of nerve damage using a neuropathy tracker
- Study objective: to determine the optimal cutoff value for this assessment system that distinguishes mild CIPN from the absence of CIPN
- Study duration: The study is expected to last approximately 3 months in total; each patient’s participation involves self-assessment of nerve-related symptoms
- Study characteristics: One treatment group, open-label (unblinded); no new treatment is being investigated
Trial sites
1 trial site in Germany is listed.
UKSH - Universitätsklinikum Schleswig-Holstein
Ratzeburger Allee 160, 23562 Lübeck
Status unknown
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description is based on the public trial registry (NCT07604441) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.

