Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy

NCT ID: NCT06371014

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-31

Brief Summary

Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Children recruited to arm-B received Ondansetron tablet plus dexamethasone. Ondansetron and dexamethasone were given continuously until 48hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy

Conditions

To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ondansetron mouth soluble film

Drug: ondansetron plus dexamethasone Ondansetron oral membrane lysis group, oral administration 30 minutes before chemotherapy, 8 mg bid for children over 12 years old, 4mg/ time for children 4-11 years old, bid; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy

Group Type: EXPERIMENTAL

Ondansetron oral membrane

Intervention Type: DRUG

A new oral film formulation of ondansetron was used to replace traditional tablets in the treatment of antiemetic chemotherapy

Ondansetron tablet

Ondansetron tablet group, oral administration 30 minutes before chemotherapy, 5mg/m2 q12h po; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy

Group Type: EXPERIMENTAL

Ondansetron oral membrane

Intervention Type: DRUG

A new oral film formulation of ondansetron was used to replace traditional tablets in the treatment of antiemetic chemotherapy

Interventions

Ondansetron oral membrane

A new oral film formulation of ondansetron was used to replace traditional tablets in the treatment of antiemetic chemotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged 4 to 15 years who have been diagnosed with malignant tumor through pathological examination and need to receive chemotherapy, gender is not limited;
• Receive moderate and low grade emetic chemotherapy;
• Patients with a score greater than 60 or higher have a life expectancy greater than 3 months;
• The patients were enrolled voluntarily, and the family members signed the informed consent, and the family members had good compliance and accurately recorded the vomiting diary.

Exclusion Criteria

• Children allergic to 5HT3 antagonists;
• Active infection;
• Abnormal bone marrow function (absolute neutrophil count <1000/mm3 platelet count <100000/mm3);
• Abnormal renal function in serum creatinine beyond the upper age limit of normal (ULN);
• Abnormal liver function of serum aspartate aminotransferase and alanine aminotransferase, age and serum bilirubin are 1.5 times that of ULN;
• vomiting 24 hours before chemotherapy begins;
• Start systemic corticosteroid therapy within 72 hours prior to study drug use, or plan to receive corticosteroids as part of a chemotherapy regimen;
• Patients with benzodiazepines or opioids

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 33724754 (View on PubMed)

Patel P, Robinson PD, Thackray J, Flank J, Holdsworth MT, Gibson P, Orsey A, Portwine C, Freedman J, Madden JR, Phillips R, Sung L, Dupuis LL. Guideline for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric cancer patients: A focused update. Pediatr Blood Cancer. 2017 Oct;64(10). doi: 10.1002/pbc.26542. Epub 2017 Apr 28.

Reference Type: BACKGROUND

PMID: 28453189 (View on PubMed)

Other Identifiers

Ondansetron mouth soluble film

Identifier Type: -

Identifier Source: org_study_id