Status:
NOT_YET_RECRUITING
Stibium Metallicum Praeparatum 6x Versus Placebo in the Prevention of Paclitaxel-induced Peripheral Neurotoxicity
Lead Sponsor:
University of Bern
Collaborating Sponsors:
Insel Gruppe AG, University Hospital Bern
Hospital of Thun
Conditions:
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Chemotherapy induced peripheral neuropathy (CIPN) is one of the most limiting side effects of chemotherapy and often leads to adaptations in the protocol of the chemotherapy including dose reduction o...
Detailed Description
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most limiting side effects of chemotherapy and often leads to adaptations in the administration of the chemotherapy, including dose redu...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age ≥ 18
- Individuals with early breast cancer, stage I to IIIC, who are about to receive a paclitaxel-based neo-adjuvant or adjuvant chemotherapy, with a planned dosing regimen of 80 mg of paclitaxel per square meter of body surface by intravenous infusion weekly for 12 doses.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Ability to provide informed consent as documented by signature
- Ability to read, write, and speak German
- Exclusion Criteria:
- Patients with pre-existing neuropathy
- Prior chemotherapy with taxanes or other neurotoxic agents
- Concomitant medications that are known to cause neuropathy
- Pregnancy or lactation
- Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Patients with psychiatric, addictive or any disorder that prevents the patient from adhering to the protocol requirements, in the opinion of the investigator
- Lactose intolerance or glucose-galactose-malabsorption, as well as any other contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
- Life expectancy \< 3 months
Exclusion
Key Trial Info
Start Date :
August 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04715542
Start Date
August 1 2026
End Date
August 1 2029
Last Update
November 25 2025
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