Treatment of Chemotherapy-induced Nausea and Vomiting
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|ClinicalTrials.gov Identifier: NCT01101529|
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : December 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Nausea Vomiting||Drug: Aprepitant (Emend) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Controlled Study to Compare (EMEND®)to Standard Treatment as Prevention for Delayed Chemotherapy-induced Nausea and Vomiting (CINV) After Myeloablative Therapy for Patients Undergoing Autologous Stem Cell Transplantation.|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Placebo Comparator: Standard antiemetic therapy plus placebo
Standard anti-emetic prophylaxis consisting of 1/dexamethasone 6 mg daily during the chemotherapy days and 2/tropisetron (Navoban)5 mg daily during chemotherapy and 2 days after
Placebo will be administered instead of Emend
Experimental: aprepitant (Emend)
Aprepitant given orally 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after as an addition to standard antiemetic therapy as in the placebo arm.
Drug: Aprepitant (Emend)
Aprepitant will be added to the standard anti-emetic therapy. Emend is given orally, 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after
Other Name: Emend
- Vomiting and nausea [ Time Frame: 7 days ]The proportion of patients with a complete response (no vomiting and/or only mild nausea and no use of rescue therapy) a/ during chemotherapy and b/ in the delayed phase (up to 7 days after end of chemotherapy).
- Safety and tolerability of the aprepitant regimen for CINV [ Time Frame: 3 weeks ]Possible side effects will be recorded, and all AE:s reported during 3 weeks after the chemotherapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101529
|Uppsala University Hospital|
|Uppsala, Sweden, 75185|
|Principal Investigator:||Gunnar Birgegard, MD, PhD||University Hospital, Uppsala, Sweden|