N/A Completed N=40 Randomized Quadruple-blind Supportive Care

Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

Cancer

Source: ClinicalTrials.gov NCT00248547 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Dec 2011

Primary outcomePrimary: Number of Emesis Free Participants During the Study Period. — 13; 5 Participants — p=0.041

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Emesis Free Participants During the Study Period.	13; 5	0.041 sig
SECONDARY Safety in Transplant Population	—	—
SECONDARY Effects on Nausea, Appetite and Taste Changes	—	—
SECONDARY Pharmacokinetic Interaction	—	—

Eligibility Criteria

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*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

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Data sourced from ClinicalTrials.gov (NCT00248547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.