- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070677
Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients
Prospective, Multicenter Clinical Study Assessing the Effect of ZIVEREL® on the Symptomatic Treatment of Radiation Oesophagitis in Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eliseo Carrasco Esteban, MD
- Phone Number: 0034 609438605
- Email: eliseo.carrasco.esteban@gmail.com
Study Contact Backup
- Name: Fernando López Campos, MD
- Email: flcampos@salud.madrid.org
Study Locations
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-
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Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon y Cajal
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Contact:
- Fernando López Campos
- Email: flcampos@salud.madrid.org
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Principal Investigator:
- Eliseo Carrasco Esteban
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Principal Investigator:
- Fernando López Campos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ziverel arm
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.
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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®
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptomatic relief of radiation-induced esophagitis grade ≥2 in cancer patients undergoing radiotherapy and radiochemotherapy after administration of ZIVEREL®.
Time Frame: 1 year
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Symptomatic relief of radiation-induced esophagitis grade ≥2
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dosimetric prognostic factors
Time Frame: 1 year
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Determine the dosimetric prognostic factors in the development of radiation induced esophagitis (Dmed, Dmax, V5, V15, V20, V30, V35, V40, V45, V50, V60)
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1 year
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Analyze the health-related quality of life during the treatment
Time Frame: 1 year
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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
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZESRAD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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