Status:
COMPLETED
Observational Study of Delayed Nausea and Vomiting
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Vomiting
Eligibility:
All Genders
18+ years
Brief Summary
Delayed emesis following administration of carboplatin-based chemotherapy despite prophylaxis with standard antiemetic prophylaxis (5-HT3 and corticosteroid) remains a clinically significant and distr...
Detailed Description
All patients will be given the Functional Living Index- Emesis (FLIE), a standardized questionnaire. This is a self-administered questionnaire to assess the impact of nausea and vomiting on the patien...
Eligibility Criteria
Inclusion
- Patients must have newly diagnosed, histologically or cytologically proven cancer, and be scheduled to receive chemotherapy with carboplatin at AUC 5 or above.
- Patients should receive standard antiemetic prophylaxis prior to carboplatin administration, defined as 5-HT3 antagonist and dexamethasone. We will include only patients whose standard care includes treatment with a carboplatin-containing regimen and who are not being treated with aprepitant (Emend®).
- Age \>= 18.
- After being informed of the treatment involved, patients must give written consent.
- Entry to this study is open to both men and women and to all racial and ethnic subgroups.
Exclusion
- No prior cytotoxic chemotherapy within the last 5 years.
- Should not be pregnant.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00696280
Start Date
November 1 2006
End Date
November 1 2009
Last Update
June 12 2013
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110