MedTrace Logo

Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients

NCT04070677 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-08-05

No results posted yet for this study

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.

Conditions

  • Acute Esophagitis

Interventions

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®

Sponsors & Collaborators

  • Norgine

    collaborator INDUSTRY

  • Grupo de Investigación Clínica en Oncología Radioterapia

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-15
Primary Completion
2022-06-30
Completion
2023-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04070677 on ClinicalTrials.gov