Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients

Grupo de Investigación Clínica en Oncología Radioterapia

Status: Unknown

Conditions: Acute Esophagitis

Treatments: Combination Product: Ziverel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04070677

ZESRAD

Details and patient eligibility

About

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.

Full 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 associated with several key processes, including cell signaling and repair, as well as with tissue generation, morphogenesis, and structural organization of the extracellular matrix itself. In clinical terms, its role is well known in conditions such as mouth ulcers, where its barrier effect relieves symptoms. Chondroitin sulfate forms part of the glycosaminoglycan group in the extracellular matrix, which is in turn formed by D-glucuronic acid and N-acetylgalactosamine. It has been shown to protect the epithelium of the esophageal mucosa by shielding the epithelial areas damaged by acid, thus diminishing catabolic activity and inhibiting proteolytic enzymes (e.g., metalloproteases, collagenase, or elastase). Chondroitin sulfate also regulates several inflammatory mediators (TNF-α, IL-1β, COX-2, PGE2, and NFκB) and reduces the synthesis of nitric oxide, which is involved in the inflammatory cascade. Polaxamer 407 is a bioadhesive component that acquires the active ingredients of ZIVEREL® adhere to the damaged mucosa and are not dragged away by the ingestion of food and liquids.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Ziverel arm

Experimental group

Description:

Patients included will receive treatment with ZIVEREL®, initially 10 mL every 8 hours, 30 minutes after meals, to avoid physical entrainment by food, during a minimum of 8 weeks, recruited during a period of 12 months. The treatment will be indicated when the patient develops a radiation-induced esophagitis of degree ≥ 2.

Treatment:

Combination Product: Ziverel