Observational Study of Delayed Nausea and Vomiting (DelayedNaus)
Delayed emesis following administration of carboplatin-based chemotherapy despite prophylaxis with standard antiemetic prophylaxis (5-HT3 and corticosteroid) remains a clinically significant and distressing problem for patients with cancer. The incidence of delayed emesis appears to be higher in women compared to men.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Observational Study of Delayed Nausea and Vomiting Following Administration of Carboplatin-containing Regimens for Treatment of Cancer|
|Study Start Date:||November 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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 patient's functional living, including physical activities, social and emotional function, and ability to enjoy food and drink. Patients will complete the questionnaire during the 5 days following carboplatin administration (at 24 hours, 48 hours, 72 hours and 96 hours) during their first and third cycles of chemotherapy. The questionnaire should take approximately 10 minutes or less to complete.
Patients will also be interviewed by a trained CRA or research nurse over the telephone 24-48 hours following carboplatin administration in order to assess the severity of the delayed nausea and vomiting.
|United States, Missouri|
|Washington University School of medicine|
|St. Louis, Missouri, United States, 63118|
|Principal Investigator:||Maria Q Baggstrom, M.D.||Washington University School of Mecicine|