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

Primary Purpose

Olanzapine, CINV, Testicular Cancer by AJCC V6 and V7 Stage

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Olanzapine Tablets
Placebo
Sponsored by
Shi Yanxia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Olanzapine focused on measuring testicular cancer, olanzapine, Cisplatin 5-day regimen, Nausea and vomiting

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria

Patients must meet the following criteria for inclusion:

  1. Pathology confirmed germ cell tumor (both spermatogonoma and non-spermatogonoma) and had no chemotherapy before;
  2. Men;
  3. Age ≥16 years old;
  4. ECOG score of physical status 0-2;
  5. Chemotherapy regimen containing 5-day cisplatin (20mg/m2, 100mg total;
  6. No other nausea, vomiting, or use of any antiemetics within 72 hours prior to enrollment;
  7. There are no clear brain metastases or other reasons for long-term systemic use of hormones;
  8. 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

  9. Ability to read, understand and complete research questionnaires and journals, including visual analog scale (VAS);
  10. 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:

  1. Digestive tract obstruction, water and electrolyte disorder;
  2. Have central nervous system diseases (such as primary brain tumors, uncontrolled seizures, any history of brain metastases or strokes);
  3. 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;
  4. Patients with mental disabilities or severe emotional or mental disorders are considered unsuitable for inclusion in the study;
  5. 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;
  6. The patient is currently using any prohibited drugs, including medicinal marijuana or is currently using alcohol (Chinese Diagnostic criteria for drug dependence);
  7. The patient received an unapproved (experimental) drug treatment within the past 4 weeks;
  8. Taking oral olanzapine or other psychotropic drugs;
  9. A history of hypersensitivity to fosappitan, 5-HT3 receptor antagonists or dexamethasone;
  10. The patient cannot swallow the drugs;
  11. The principal investigator considered the patients unsuitable for the study;
  12. Inability or unwillingness to adhere to research protocols

Sites / Locations

  • Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Olanzapine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants With minimal nausea
Minimal nausea was defined as <25 mm on a visual analog scale
Percentage of Participants with total control
total control was defined as no vomiting, no rescue antiemetics, and no nausea
Severity of nausea
Number of rescue medications
Number of rescue medications for nause and vormitting
Time to Treatment Failure in each group of participates
Time to treatment failure was defined as time to 1st emetic episode or use of rescue medication
Patient's satisfaction with anti-emetic therapy
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

Full Information

First Posted
January 9, 2022
Last Updated
February 3, 2023
Sponsor
Shi Yanxia
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1. Study Identification

Unique Protocol Identification Number
NCT05244577
Brief Title
Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shi Yanxia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olanzapine, CINV, Testicular Cancer by AJCC V6 and V7 Stage, Cisplatin
Keywords
testicular cancer, olanzapine, Cisplatin 5-day regimen, Nausea and vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Olanzapine Tablets
Other Intervention Name(s)
Olanzapine
Intervention Description
Olanzapine,Ondansetron,Dexamethasone,Fosaprepitant
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo,Ondansetron,Dexamethasone,Fosaprepitant
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Response From 0 to 240 Hours After Initiation chemotherapy
Description
Complete Response was defined as no vomiting and no use of rescue medication
Time Frame
1 to 10 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With minimal nausea
Description
Minimal nausea was defined as <25 mm on a visual analog scale
Time Frame
1-10 days
Title
Percentage of Participants with total control
Description
total control was defined as no vomiting, no rescue antiemetics, and no nausea
Time Frame
1 to 10 days
Title
Severity of nausea
Time Frame
1 to 10 days
Title
Number of rescue medications
Description
Number of rescue medications for nause and vormitting
Time Frame
1 to 10 days
Title
Time to Treatment Failure in each group of participates
Description
Time to treatment failure was defined as time to 1st emetic episode or use of rescue medication
Time Frame
1 to 10 days
Title
Patient's satisfaction with anti-emetic therapy
Description
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
Time Frame
1 to 10 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanxia Shi, PHD
Phone
+8613609058827
Email
shiyx@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xin An, PHD
Phone
+8613650798675
Email
anxin@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanxia Shi, PHD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxia Shi, PHD
Phone
13609058827
Email
shiyx@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No
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Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer

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