Last updated: February 20, 2024
Sponsor: The First Affiliated Hospital of Xinxiang Medical College
Overall Status: Active - Recruiting
Phase
3
Condition
Colic
Vomiting
Gastroenteritis
Treatment
Ondansetron Oral Soluble Pellicles
Clinical Study ID
NCT06282211
CHASE 005
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 years, gender is not limited;
- Histologically or cytologically confirmed diagnosis of malignant solid tumor;
- Initial highly emetogenic one-day chemotherapy regimen (cisplatin dose 60-75 mg/m2;anthracycline compound adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ); and
- Nausea and vomiting prophylaxis with a triple regimen of fosaprepitant + ondansetronorally dissolved membrane + dexamethasone started before chemotherapy;
- Expected survival ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) physical status score ≤2;
- Patients were able to read, understand, and complete study questionnaires;
- Patients understood the study procedures and signed a written informed consent form
Exclusion
Exclusion Criteria:
- Patients scheduled to receive multiple days of highly emetogenic chemotherapy withinone week;
- Patients using an antiemetic drug other than the study drug or a drug with anantiemetic active ingredient within 48 h prior to initiation of randomization and/orwithin one week of enrollment;
- Symptoms such as vomiting prior to randomization;
- Patients on opioid therapy (except stable dose administration);
- Patients treated with a chemotherapy regimen containing generic paclitaxel (usingcastor oil as a solvent);
- Patients who have received, or are expected to receive, radiotherapy to the abdomen (including the diaphragmatic plane and below) or pelvis within 1 week beforerandomization or one week after enrollment;
- Patients with active infection (e.g., pneumonia) or any uncontrolled disease (e.g.,diabetic ketoacidosis, gastrointestinal obstruction) other than malignancy;
- The patient has participated in another clinical trial within the past 4 weeks;
- Any condition that, in the judgment of the investigator, is unstable or may jeopardizethe safety of the subject and his or her compliance with the study;
- Pregnant or lactating females;
- Presence of allergic conditions or prior serious adverse reactions to the study drugand excipients;
- Suffering from psychological, familial, social, or geographic conditions that mayprevent compliance with the study protocol and follow-up schedule;
Study Design
Total Participants: 184
Treatment Group(s): 1
Primary Treatment: Ondansetron Oral Soluble Pellicles
Phase: 3
Study Start date:
February 20, 2024
Estimated Completion Date:
December 29, 2024
Study Description
Connect with a study center
Keya Zhi
Weihui, None Selected 453100
ChinaActive - Recruiting
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