Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer (NCT05403580) | Clinical Trial Compass
WithdrawnPhase 3
Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer
Stopped: Closed due to slow accrual
0Started 2022-06-03
Plain-language summary
This phase III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Giving olanzapine may help reduce nausea and increase appetite in patients who have advanced cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>= 18 years
* Histologically or cytologically-confirmed cancer in an advanced incurable stage
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Chronic nausea that has been present for at least one week (daily score \> 5, on a 0-10 visual analogue scale)
* Serum creatinine \< 2.0 mg/dl =\< 120 days prior to registration
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) values \< 3 times upper limits of normal =\< 120 days prior to registration
* Negative pregnancy test done =\< 14 days prior to registration, for persons of childbearing potential only
* Able to provide written informed consent
* Able to complete questionnaire(s) by themselves or with assistance
Exclusion Criteria:
* Any of the following because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects:
* Pregnant persons
* Nursing persons
* Received chemotherapy or radiation within the prior 14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
* Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =\< 30 days prior to registration or planned during protocol therapy (patients may have received prochlorpera…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.