Clinical Trial With Aconite Pain Oil in Oncology Patients Under Chemotherapy to Prevent CIPN Grade-II, to Reduce Symptoms and to Improve the Quality of Life of Patients With CIPN

Recruiting Phase 3 Interventional Study
Chemotherapy-induced Polyneuropathy
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
350 (estimated)
Sponsor
WALA Heilmittel GmbH · Other
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About This Trial

The clinical trial is planned as a prospective, multicentre, blinded, randomised, placebo-controlled, national clinical trial in Germany. The clinical trial is designed for testing the prophylactic and therapeutic effects of Aconite pain oil as compared to placebo in oncological patients receiving neurotoxic chemotherapy with taxanes and/or platinum derivatives.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. A consent form, fully dated and signed by the patient and the principal investigator/investigator, is available 2. Patients with a minimum age of 18 years 3. Patients with a Karnofsky Index ≥ 70% 4. Patients with an assumed life expectancy of at least 12 months 5. Patients wi…
Contacts

Florian Stintzing, Prof. Dr.

klin-pruef-klifo@wala.de

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