Clinical trial NCT04070677: Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients
Official title: Prospective, Multicenter Clinical Study Assessing the Effect of ZIVEREL® on the Symptomatic Treatment of Radiation Oesophagitis in Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Esophagitis
Keywords: Acute Esophagitis
Radiotherapy
Ziverel
Chondroitin sulfate
Hyaluronic acid
Poloxamer 407
Chemoradiotherapy
Chemotherapy
Lead sponsor: Grupo de Investigación Clínica en Oncología Radioterapia
Sponsor class: OTHER
Collaborators: name: Norgine
First posted: 2019-08-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Symptomatic relief of radiation-induced esophagitis grade ≥2 in cancer patients undergoing radiotherapy and radiochemotherapy after administration of ZIVEREL®.
timeFrame: 1 year
Secondary outcomes:
measure: Dosimetric prognostic factors
timeFrame: 1 year
measure: Analyze the health-related quality of life during the treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References: