Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients

NCT04070677 | Unknown

• 1 other identifier: ZESRAD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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

Keywords

Acute Esophagitis; Radiotherapy; Ziverel; Chondroitin sulfate; Hyaluronic acid; Poloxamer 407; Chemoradiotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dosimetric prognostic factors

  1 year

• Analyze the health-related quality of life during the treatment

  1 year

Study Arms (1)

Ziverel arm

EXPERIMENTAL

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.

Combination Product: Ziverel

Interventions

Ziverel COMBINATION_PRODUCT

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®

Ziverel arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo de Investigación Clínica en Oncología Radioterapia: lead
• Norgine: collaborator

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Central Study Contacts

Eliseo Carrasco Esteban, MD

CONTACT

609438605; eliseo.carrasco.esteban@gmail.com

Fernando López Campos, MD

CONTACT

flcampos@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: August 28, 2019
• Study Start: June 15, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)