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A prospective randomized controlled trial on the pervention of multiple-day chemotherapy-induced nausea and vomiting with delayed administration and standard administration

A prospective randomized controlled trial on the pervention of multiple-day chemotherapy-induced nausea and vomiting with delayed administration and standard administration

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040675
Enrollment
Unknown
Registered
2020-12-08
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor

Interventions

Group A:standard administration of fosapitam and/or olanzapine
Group B:Delaied administration of fosapitam and/or olanzapine

Sponsors

Ordos Central Hospital,Inner Mongolia
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. aged >=18 years old, pathologically diagnosed malignant tumor to accept cisplatin regimen 25mg/m^2/day chemotherapy; 2. KPS score>=70; 3. Before chemotherapy, liver and kidney function, blood routine, electrocardiogram are normal.Blood tests must meet the requirements of white blood cells > 3.5 * 10^9, neutrophils > 1.5 *10^9, platelets > 85 *10^9, alkaline phosphatase less than 2.5 times of normal value, glutamic pyruvic transaminase 2.5 times of normal value, bilirubin 1.5 times of normal value, and creatinine 1.5 times of normal value; 4. CT and (MRI) evaluated the tumor site without chemotherapy contraindications; 5. Obtain the patient's informed consent and sign the consent form.

Exclusion criteria

Exclusion criteria: 1. Primary exclusion criteria were: patients who were unable to take oral drugs and had a long history of hormone use; 2. Those who received radiotherapy at the same time and those who had vomiting 24 hours before chemotherapy; 3. Symptomatic primary or metastatic central nervous system metastasis and and patients who have received brain radiotherapy; 4. Pregnant or breast-feeding; 5. Concurrent quinolone antibiotic therapy; 6. Partial/complete bowel obstruction; 7. Known hypersensitivity to 5-HT3 receptor; 8. Aprepitant, and olanzapine; 9. Treatment with illegal drugs or evidence of alcohol abuse; 10. Patients with gastrointestinal tumors.

Design outcomes

Primary

MeasureTime frame
overall phase total contral;

Secondary

MeasureTime frame
overall phase complete response;overall phase total protection;FILE scale;Malignant score;Side effects;

Countries

China

Contacts

Public ContactLi Quanfu

Ordos Central Hospital, Inner Mongolia, Ordos clinical Medical College, Inner Mongolia Medical University

1729259137@qq.com+86 477-8363279

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026