Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients

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 this condition as an adverse effect of oncologic therapies, in order to prevent interruption of treatment, as it has been associated with reduced survival. ZIVEREL® is a new, over-the-counter medical device that comes as an oral solution in a 10-ml stick pack. It is composed of hyaluronic acid, chondroitin sulfate, and poloxamer 407 and Women plays a role in the symptomatic relief of esophagitis induced by radiotherapy alone or radiochemotherapy in oncologic patients. ZIVEREL® acts naturally and exerts a protective action by reinforcing the effect of the elements that make up the extracellular matrix, where the connective tissue provides the architecture, proteoglycans maintain the fluid-electrolyte balance, and glycoproteins maintain the intracellular substrate responsible for cell-cell reactions and cell-matrix reactions. The objective of this study is to evaluate whether administration of ZIVEREL® diminishes the grade of acute radiation-induced esophagitis and the incidence of severe esophagitis in oncologic patients treated with radiotherapy or radiochemotherapy.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* 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 Criteria:

* 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.