Efficacy and Safety of Fosaprepitant in Preventing Chemotherapy-induced Vomiting in Children Treated With Medium and High Emetic Chemotherapeutic Drugs

NCT05230654 | Unknown

• 1 other identifier: fosaprepitant
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy Induced Nausea and Vomiting Pediatric Cancer Patients

Keywords

Fosaprepitant; Chemotherapy-induced nausea and vomiting; Pediatric patients; Emetogenic chemotherapy

Outcome Measures

Primary Outcomes (1)

• Complete remission rates in the acute phases

  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

  up to 6 months

Secondary Outcomes (2)

• Complete Remission rates in the delayed and overall phases

  up to 6 months

• Adverse events reported in study patients

  up to 6 months

Study Arms (2)

fosaprepitant

EXPERIMENTAL

Patients received intravenous Ganisetron plus dexamethasone followed by fosaprepitant infusion

Drug: Fosaprepitant

Placebo

PLACEBO COMPARATOR

Patients received intravenous Ganisetron plus dexamethasone followed by normal saline

Drug: Placebo(normal saline)

Interventions

Fosaprepitant DRUG

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.

fosaprepitant

Placebo(normal saline) DRUG

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.

Placebo

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, China

Location

Related Publications (5)

• 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.

  PMID: 26960036 BACKGROUND

• 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.

  PMID: 26449391 BACKGROUND

• 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.

  PMID: 30426714 BACKGROUND

• 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.

  PMID: 30900392 BACKGROUND

• 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.

  PMID: 23512831 BACKGROUND

MeSH Terms

Conditions

Vomiting

Interventions

fosaprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yijin Gao

  Shanghai Children's Medical Center

  STUDY DIRECTOR

Central Study Contacts

Liting Yu

CONTACT

13636303912; yuliting20091396@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: February 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)