Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer

Sponsor

Shi Yanxia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05244577

Collaborator

(none)

Enrollment

Location

Arms

14.4

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to investigate the efficacy and safety of olanzapine combined with fosaprepitant, ondansetron and dexamethasone compared with placebo combined with fosaprepitant, ondansetron and dexamethasone in the prevention of nausea and vomiting in germ-cell tumors receiving 5-day cisplatin chemotherapy

Condition or Disease	Intervention/Treatment	Phase
Olanzapine CINV Testicular Cancer by AJCC V6 and V7 Stage Cisplatin	Drug: Olanzapine Tablets Drug: Placebo	Phase 3

Detailed Description

This is a prospective, randomized, double-blind, placebo-controlled, cross-over Phase III clinical study.

A total of 75 patients were enrolled in two sequential treatment groups (olanzapine-placebo and placebo-Olanzapine).

(1) The screening process begins after the patient signs the written informed consent. (2) Patients were randomly divided into control group (placebo) and experimental group (olanzapine). (3) Patients' effectiveness from the beginning of chemotherapy drug infusion (0 h on day 1) to day 10 (approximately 240 h) was monitored by patients' diary from 2 to 10 days after chemotherapy, in which patients should report episodes of vomiting in the previous 24 hours, use of remedial therapy, and assessment of daily nausea. Any episodes of vomiting or retching, as well as the time and date of use of rescue medications, should also be recorded. At days 2 to 6, patients were assessed on the visual analog scale (VAS) for the previous 24 hours. (4) The Hospital Anxiety and Depression Scale (HADS),and Life Index - Vomiting (FLIE) questionnaire of days 1-10 should be completed immediately after the log is completed on day 10. (5) During the study period, patients may receive "remedial treatment" for nausea or vomiting, and patients requiring remedial treatment are considered to have failed treatment because the primary endpoint is complete remission. However, patients receiving remedial treatment must continue to receive the study drug and complete the diary as directed.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind, placebo-controlledRandomized, double-blind, placebo-controlled

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase III Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer Receiving 5-day Cisplatin Combination Chemotherapy

Actual Study Start Date :

Jan 18, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olanzapine Ondansetron 8mg IV, D1-5 30 minutes before chemotherapy; Dexamethasone 6mg Po QD, D1-7; Fosaprepitant 150mg IVD D1,4, 60 minutes before chemotherapy; Olanzapine 5mg Po D1-7	Drug: Olanzapine Tablets Olanzapine,Ondansetron,Dexamethasone,Fosaprepitant Other Names: Olanzapine
Placebo Comparator: Placebo Ondansetron 8mg IV, D1-5 30 minutes before chemotherapy; Dexamethasone 6mg Po QD, D1-7; Fosaprepitant 150mg IVD D1,4, 60 minutes before chemotherapy; Placebo 5mg Po D1-7	Drug: Placebo Placebo,Ondansetron,Dexamethasone,Fosaprepitant

Arm

Intervention/Treatment

Experimental: Olanzapine

Ondansetron 8mg IV, D1-5 30 minutes before chemotherapy; Dexamethasone 6mg Po QD, D1-7; Fosaprepitant 150mg IVD D1,4, 60 minutes before chemotherapy; Olanzapine 5mg Po D1-7

Drug: Olanzapine Tablets

Olanzapine,Ondansetron,Dexamethasone,Fosaprepitant

Other Names:

Olanzapine

Placebo Comparator: Placebo

Ondansetron 8mg IV, D1-5 30 minutes before chemotherapy; Dexamethasone 6mg Po QD, D1-7; Fosaprepitant 150mg IVD D1,4, 60 minutes before chemotherapy; Placebo 5mg Po D1-7

Drug: Placebo

Placebo,Ondansetron,Dexamethasone,Fosaprepitant

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Complete Response From 0 to 240 Hours After Initiation chemotherapy [1 to 10 days]
Complete Response was defined as no vomiting and no use of rescue medication

Secondary Outcome Measures

Percentage of Participants With minimal nausea [1-10 days]
Minimal nausea was defined as <25 mm on a visual analog scale
Percentage of Participants with total control [1 to 10 days]
total control was defined as no vomiting, no rescue antiemetics, and no nausea
Severity of nausea [1 to 10 days]
Number of rescue medications [1 to 10 days]
Number of rescue medications for nause and vormitting
Time to Treatment Failure in each group of participates [1 to 10 days]
Time to treatment failure was defined as time to 1st emetic episode or use of rescue medication
Patient's satisfaction with anti-emetic therapy [1 to 10 days]
The patient was asked to evaluate his satisfaction with the control of nausea and vomiting by recording two scales: Hospital Anxiety and Depression Scale and The Functional Living Index-Emesis questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must meet the following criteria for inclusion:

Pathology confirmed germ cell tumor (both spermatogonoma and non-spermatogonoma) and had no chemotherapy before;
Men;
Age ≥16 years old;
ECOG score of physical status 0-2;
Chemotherapy regimen containing 5-day cisplatin (20mg/m2, 100mg total;
No other nausea, vomiting, or use of any antiemetics within 72 hours prior to enrollment;
There are no clear brain metastases or other reasons for long-term systemic use of hormones;
The general condition is good, and the blood, liver and kidney functions meet the following standards:

Hemoglobin: 90 g/L and above White blood cell count: 3.5 * 109 / L - 10.0 109 / L Neutrophil count: 1.5 109/L or above Platelet count: 90* 109/L or above Serum total bilirubin: below 1.5 times the upper limit of normal Serum AST, ALT and ALP: the upper limit of normal is below 2.5 times when the patient is present

Ability to read, understand and complete research questionnaires and journals, including visual analog scale (VAS);
Understand the study procedure and sign the informed consent in person to participate in the study

Exclusion Criteria

Patients who meet any of the following criteria will be excluded:

Digestive tract obstruction, water and electrolyte disorder;
Have central nervous system diseases (such as primary brain tumors, uncontrolled seizures, any history of brain metastases or strokes);
Contraindications to the use of glucocorticoids: ① Viral, bacterial, fungal and other infections that cannot be controlled by antibiotics;② Active gastric or duodenal ulcer;③ Severe hypertension, arteriosclerosis, diabetes; ④ Osteoporosis;⑤ Corneal ulcer;⑥Trauma or surgical repair period, fracture; ⑦Adeno-cortical hyperfunction; ⑧Severe mental illness and epilepsy; ⑨ patients with cardiac or renal dysfunction;
Patients with mental disabilities or severe emotional or mental disorders are considered unsuitable for inclusion in the study;
In addition to malignancy, the patient has an active infection (e.g. pneumonia, hepatitis) or any uncontrolled infection diseases (such as diabetic ketoacidosis), and the researchers believe may contribute to the study's findings confounding, or exposing patients receiving study drugs to unnecessary risks;
The patient is currently using any prohibited drugs, including medicinal marijuana or is currently using alcohol (Chinese Diagnostic criteria for drug dependence);
The patient received an unapproved (experimental) drug treatment within the past 4 weeks;
Taking oral olanzapine or other psychotropic drugs;
A history of hypersensitivity to fosappitan, 5-HT3 receptor antagonists or dexamethasone;
The patient cannot swallow the drugs;
The principal investigator considered the patients unsuitable for the study;
Inability or unwillingness to adhere to research protocols