Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients

Gynecologic Cancer Clinical Trial

Official title:

Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04503668
• Other study ID #: UMCC 2019.173
• Secondary ID: HUM00175458
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 28, 2020
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: March 2024
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Diagnosis of gynecologic malignancy
• No chemotherapy in the last 12 months
• Scheduled to receive Carboplatin (AUC>=4) and Paclitaxel every three weeks
• ECOG performance status 0 or 1
• English speaking
• Willing and able to provide informed consent
• Laboratory values within protocol-defined parameters
• No vomiting in the 24 hours prior to initiating chemotherapy
• If childbearing potential exists, negative pregnancy test within 7 days prior to registration

Exclusion Criteria:

• Significant cognitive compromise
• History of CNS disease (e.g. brain metastases, seizure disorder, dementia)
• Current or recent (within 30 days) treatment with another antipsychotic agent (antidepressant medications are OK)
• Concurrent radiotherapy treatment
• Known hypersensitivity to olanzapine
• Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the last six months
• History of diabetes mellitus on medication (insulin or oral glycemic agent)
• Alcohol abuse / chronic alcoholism
• History of closed angle glaucoma
• Current enrollment in other clinical trials

Related Conditions & MeSH terms

• Gynecologic Cancer
• Vomiting

Intervention

Drug:
• Ondansetron
8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy
• Dexamethasone
20 mg IV on day 1 pre-chemotherapy
• Neurokinin-1 Receptor Antagonist (NK1-RA)
150 mg IV on day 1 pre-chemotherapy
• Olanzapine
5 mg by mouth on days 1-4 of chemotherapy (taken at night)
• Compazine
5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete response in the overall time period (0 - 120 hours post-chemotherapy)	Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.	At day 6
Secondary	Rate of complete response in the acute time period (0 - 24 hours post-chemotherapy)	Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.	At day 2
Secondary	Rate of complete response in the delayed time period (24 - 120 hours post-chemotherapy)	Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.	At day 6
Secondary	Rate of no nausea in the acute time period (0 - 24 hours post-chemotherapy)	Patients will record daily levels of nausea after chemotherapy using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).	At day 2
Secondary	Rate of no nausea in the delayed time period (24 - 120 hours post-chemotherapy)	Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).	At day 6
Secondary	Rate of no nausea in the overall time period (0 - 120 hours post-chemotherapy)	Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).	At day 6
Secondary	Mean somnolence score	Patients will record daily levels of undesired sedation using a Likert scale ranging from 0 to 10 (0 indicating no undesired sedation; 10 indicating maximum level of undesired sedation).	At day 6
Secondary	Mean increased-appetite score	Patients will record daily levels of undesired increase in appetite using a Likert scale ranging from 0 to 10 (0 indicating no undesired increase in appetite; 10 indicating maximum level of undesired increase in appetite).	At day 6