Clinical trial · Interventional
Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplatation(HCT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aprepitant | Drug | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| ondansetron | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Aprepitant
- interventionNames
- Drug: aprepitant
- Drug: dexamethasone
- Drug: ondansetron
- type
- PLACEBO_COMPARATOR
- label
- sugar pill
- description
- Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
- interventionNames
- Drug: dexamethasone
- Drug: ondansetron
- Drug: placebo
Primary outcomes (1)
- measure
- Number of Emesis Free Participants During the Study Period.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available