- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05230654
Efficacy and Safety of Fosaprepitant in Preventing Chemotherapy-induced Vomiting in Children Treated With Medium and High Emetic Chemotherapeutic Drugs
January 28, 2022 updated by: Shanghai Children's Medical Center
This study was a prospective, randomized, double-blind, parallel controlled clinical trial.
The children who met the inclusion criteria and were treated with medium and high emetic chemotherapy drugs were randomly included in the experimental group (forsapitan group) and the control group (placebo group) in the ratio of 1 ∶ 1.
The children in the experimental group were infused with fosapitan, dexamethasone and granisetron before chemotherapy, and then continued to be infused with granisetron and dexamethasone until 48 hours after the end of chemotherapy.
The antiemetic regimen of children in the control group was placebo instead of fosapitan, and the others were the same as those in the experimental group.
In this study, CNNC antiemetic scale and pediatric scale proposed by Dupuis were used to evaluate the vomiting data.
The primary end point was the proportion of children who achieved complete remission (CR) in the delayed period (within 24-120 hours after the start of chemotherapy); The secondary end points were the CR rate in the acute phase (within 24 hours after the first chemotherapy administration) and the overall phase.
The antiemetic efficacy and adverse reactions of the two groups were observed and analyzed.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liting Yu
- Phone Number: 13636303912
- Email: yuliting20091396@163.com
Study Locations
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Shanghai, China
- Shanghai Children's Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children aged 2-12 years at the time of study entry with documented cancer scheduled to receive MEC or HEC (more than 30% emetogenic potential) with Karnofsky score of 60 or more (for patients aged greater than 10 years) or Lansky play performance score of 60 or more (for patients aged 10 years or less) predicted life expectancy of at least 3 months; and written informed consent provided by parent or guardian
Exclusion Criteria:
- vomiting 24 hours before treatment day 1 known history of QT prolongation or allergic reaction to any of the study drugs symptomatic primary or metastatic CNS malignancy causing nausea or vomiting patients who received radiation therapy to the abdomen or pelvis in the week before treatment; active infection or any uncontrolled concurrent illness except for malignancy abnormal laboratory values at screening (peripheral absolute neutrophil count <1000 cells per μL, platelet count <100 000 cells per μL; alanine amino transferase or aspartate aminotransferase >5 times of the upper limit of normal for age, bilirubin or serum creatinine >1.5 times of the upper limit of normal for age) initiation of systemic corticosteroids within 72 hours before study drug administration or as part of the chemotherapy regimen; benzodiazepines or opioids initiated within 48 hours before treatment, except for single doses of triazolam, temazepam, or midazolam use of antiemetics within 48 hours of treatment use of CYP3A4 substrates or inhibitors within 7 days or CYP3A4 inducers within 30 days of treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fosaprepitant
Patients received intravenous Ganisetron plus dexamethasone followed by fosaprepitant infusion
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Fosaprepitant: 4 mg/kg IV Granisetron+dexamethasone: granisetron:40mcg/kg, IV ; dexamethasone : S<0.6m2, 2 mg/dose, q12h IV/PO; S>0.6m2, 4 mg/dose, q12h , IV/PO.
When used with fosaprepitant, dexamethasone dose was halved.
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Placebo Comparator: Placebo
Patients received intravenous Ganisetron plus dexamethasone followed by normal saline
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Placebo(normal saline): 4 ml/kg IV Granisetron+dexamethasone: granisetron:40mcg/kg, IV ; dexamethasone : S<0.6m2, 2 mg/dose, q12h IV/PO; S>0.6m2, 4 mg/dose, q12h , IV/PO.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete remission rates in the acute phases
Time Frame: up to 6 months
|
The primary end point was complete remission rates in the acute phase.
Complete Remission was defined as no vomiting, no retching, and no use of rescue medecation
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up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Remission rates in the delayed and overall phases
Time Frame: up to 6 months
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Complete Remission rates in the delayed and overall phases
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up to 6 months
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Adverse events reported in study patients
Time Frame: up to 6 months
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All of the adverse reaction of aprepitant and fosaprepitant during the study
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up to 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yijin Gao, Shanghai Children's Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Flank J, Robinson PD, Holdsworth M, Phillips R, Portwine C, Gibson P, Maan C, Stefin N, Sung L, Dupuis LL. Guideline for the Treatment of Breakthrough and the Prevention of Refractory Chemotherapy-Induced Nausea and Vomiting in Children With Cancer. Pediatr Blood Cancer. 2016 Jul;63(7):1144-51. doi: 10.1002/pbc.25955. Epub 2016 Mar 9.
- Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Vallejos W, Liang LW, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016 Jan;27(1):172-8. doi: 10.1093/annonc/mdv482. Epub 2015 Oct 8.
- Radhakrishnan V, Joshi A, Ramamoorthy J, Rajaraman S, Ganesan P, Ganesan TS, Dhanushkodi M, Sagar TG. Intravenous fosaprepitant for the prevention of chemotherapy-induced vomiting in children: A double-blind, placebo-controlled, phase III randomized trial. Pediatr Blood Cancer. 2019 Mar;66(3):e27551. doi: 10.1002/pbc.27551. Epub 2018 Nov 13.
- Mora J, Valero M, DiCristina C, Jin M, Chain A, Bickham K. Pharmacokinetics/pharmacodynamics, safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients. Pediatr Blood Cancer. 2019 Jun;66(6):e27690. doi: 10.1002/pbc.27690. Epub 2019 Mar 21.
- Dupuis LL, Boodhan S, Holdsworth M, Robinson PD, Hain R, Portwine C, O'Shaughnessy E, Sung L; Pediatric Oncology Group of Ontario. Guideline for the prevention of acute nausea and vomiting due to antineoplastic medication in pediatric cancer patients. Pediatr Blood Cancer. 2013 Jul;60(7):1073-82. doi: 10.1002/pbc.24508. Epub 2013 Mar 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2022
Primary Completion (Anticipated)
April 1, 2022
Study Completion (Anticipated)
May 1, 2022
Study Registration Dates
First Submitted
January 28, 2022
First Submitted That Met QC Criteria
January 28, 2022
First Posted (Actual)
February 9, 2022
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
January 28, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- fosaprepitant
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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