Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients

Acute Esophagitis Clinical Trial

Official title:

Prospective, Multicenter Clinical Study Assessing the Effect of ZIVEREL® on the Symptomatic Treatment of Radiation Oesophagitis in Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070677
• Other study ID #: ZESRAD
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2021
• Source: Grupo de Investigación Clínica en Oncología Radioterapia
• Contact: Eliseo Carrasco Esteban, MD
• Phone: 609438605
• Email: eliseo.carrasco.esteban[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Esophagitis
• Esophagitis

Intervention

Combination Product:
• Ziverel
Patients in treatments with radiotherapy alone (RT) or radiochemotherapy (RT-CH) with acute radiation-induced esophagitis grade 2 or superior according to the most recent CTCAE will received support treatment with ZIVEREL®

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Grupo de Investigación Clínica en Oncología Radioterapia	Norgine

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic relief of radiation-induced esophagitis grade =2 in cancer patients undergoing radiotherapy and radiochemotherapy after administration of ZIVEREL®.	Symptomatic relief of radiation-induced esophagitis grade =2	1 year
Secondary	Dosimetric prognostic factors	Determine the dosimetric prognostic factors in the development of radiation induced esophagitis (Dmed, Dmax, V5, V15, V20, V30, V35, V40, V45, V50, V60)	1 year
Secondary	Analyze the health-related quality of life during the treatment	EORTC QLQ-C30 (version 3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.; Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.; All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems	1 year