CompletedPhase 4

Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea

181 participantsStarted 2003-08

Plain-language summary

The purpose of this study is to compare two different treatment protocols for treating nausea and vomiting in patients who have undergone bone marrow transplant. Patients will be assigned to one of two treatment groups. The first group will recieve ondansetron (Zofran) tablets combined with a medicine called dexamethasone given IV. Both of these drugs are commercially available. Patients in the second treatment consists of the first two drugs, plus a newly approved drug known as aprepitant (MK-869, Emend). This combination will be the treatment being tested. The combination is approved by the FDA for chemotherapy regimens known to cause a lot of nausea and vomiting. It significantly decreases the delayed (more than 24 hours after therapy) nausea and vomiting seen with these regimens.

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: * Diagnosis of cancer, admitted for myelosupppresive stem cell transplantation. Included preparative regimens include: TBI/VP16/CY, TBI/CY, BU/CY (PO \& IV), and BCV * Age 18 or older * Alcohol intake \<100 gm/d for the last year (\< approximately 5 drinks per day) * Renal function: estimated or measured CrCl 50 ml/min * Liver function: T.Bili \<1.5, AST \< 2x ULN, unless due to disease * Able to swallow tablets and capsules Exclusion Criteria: * Age \< 18 * High alcohol intake \[\> 100 gm/d in the last year\] * Allergy or intolerance to: ondansetron or dexamethasone * Renal dysfunction \[measured or estimated CrCl \< 50 ml/min\] * Liver dysfunction \[T.Bili \> 1.5, AST \> 2x ULN, unless due to disease\] * Inability to swallow tablets or capsules * Concurrent condition requiring systemic steroid use * Nonmyeloablative SCT, patients receiving the conditioning regimens not included \[see inclusion criteria\] * History of anticipatory nausea and vomiting

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.

What they're measuring

Complete Response Rates Among Standard of Care and Combination Therapy Groups.

Timeframe: 14 days

Trial details

NCT IDNCT00781768

SponsorLoyola University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-10

Results submitted2017-12-14

View on ClinicalTrials.gov More Nausea trials