Status:
UNKNOWN
Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients
Lead Sponsor:
Grupo de Investigación Clínica en Oncología Radioterapia
Collaborating Sponsors:
Norgine
Conditions:
Acute Esophagitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Radiation-induced esophagitis is an acute, dose-limiting toxicity in oncologic treatment. Since it can lead to interruption of treatment, hospitalization, and even death, clinicians should be aware of...
Detailed Description
Hyaluronic acid is a glycosaminoglycan formed by glucuronic acid and N acetylglucosamine disaccharide units. It is found mainly in the extracellular matrix of the loose connective tissue and is associ...
Eligibility Criteria
Inclusion
- ECOG PS 0-1.
- Signature of informed consent.
- Patients with any type of neoplasm that requires treatment with radiotherapy or radiochemotherapy, and who develop a radiation-induced esophagitis of degree ≥ 2 (according to CTCAE v4.03)
- Hematological function (neutrophils ≥2000 / ml, platelets ≥100000 / ml, hemoglobin\> gr / dl), hepatic (bilirubin \<1.5) and renal acceptable (glomerular filtration rate\> 50 ml / min).
- Patients without contraindication for the administration of ZIVEREL®, in accordance with the instructions for use of the product.
Exclusion
- ECOGPS≥2
- Hypersensitivity for some of the active ingredients or a component of ZIVEREL®
- Alteration in haematological function (neutrophils ≤2000 / ml, platelets ≤100000 / ml, hemoglobin \<8gr/dl), hepatic (bilirubin\> 1.5) and/or glomerular filtration rate \<50 ml/min).
- Patients who have a medical history of psychiatric disorders or any other condition that interfere with the study
- Patients with esophageal candidiasis or oral cavity candidiasis at the time of entry into the study.
Key Trial Info
Start Date :
June 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04070677
Start Date
June 15 2019
End Date
June 30 2023
Last Update
August 5 2021
Active Locations (1)
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1
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034