Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant (NCT00248547) | Clinical Trial Compass
CompletedNot Applicable
Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
United States40 participantsStarted 2004-05
Plain-language summary
RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.
PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.
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:
* 18 years of age or greater
* must be scheduled for an autologous or allogeneic bone marrow or peripheral stem cell transplant
* Eastern Cooperative Oncology Group(ECOG) performance status \< or = 2
* patients must have signed informed consent
* must be able to swallow tablets and capsules
* must be receiving a cyclophosphamide containing regimen.
Exclusion:
* patient has known sensitivity to aprepitant, ondansetron, or dexamethasone
* patient has received another investigational drug in the past 30 days
* patient has had emesis or requires antiemetic agents in the 48 hours prior to beginning conditioning therapy
* patient has taken neurokinin-1 antagonists for 14 days prior to enrollment
* patient is pregnant, has a positive serum human chorionic gonadotropin(hCg) or is lactating
* patient has serum creatinine level \> or = 2\*ULN
* patient has severe hepatic insufficiency (Child-Pugh score \>9)
* patient drinks \> 5 drinks/day for the last year
* patient with concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning therapy
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
1
Number of Emesis Free Participants During the Study Period.