Observational Study of Delayed Nausea and Vomiting

Completed

• Conditions: Vomiting
• Interventions: Behavioral: Functional Living Index - Emesis

• Registration Number: NCT00696280
• Lead Sponsor: Washington University School of Medicine

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 distressing problem for patients with cancer. The incidence of delayed emesis appears to be higher in women compared to men.

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 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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-12
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 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 Criteria

• No prior cytotoxic chemotherapy within the last 5 years.
• Should not be pregnant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Functional Living Index - Emesis	All patients will be given the Functional Living Index - Emesis (FLIE) standardized questionnaire during their scheduled clinic visit prior to receiving chemotherapy. This is a self-administered questionnaire. Patients will complete the questionnaire during the 5 days following carboplatin administration (at 24 hours, 48 hours, 72 hours, and 96 hours) of their first and third cycles of chemotherapy. 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.

Primary Outcome Measures

Name	Time	Method
Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens	After 1st cycle of chemotherapy	Despite appropriate administration of standard 5-HT3 receptor antagonist antiemetic prophylaxis after the first cycle of chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens	After 3rd cycle of chemotherapy	Despite appropriate administration of standard antiemetic prophylaxis after the third cycle of chemotherapy
Characterize the differences in incidence of delayed nausea and vomiting among male and female patients receiving carboplatin.	Through the end of 3 cycles of therapy
Assess the need for breakthrough nausea and vomiting control in patients following administration of carboplatin-containing chemotherapy regimens	Through the end of 3 cycles of therapy	Despite appropriate administration of standard antiemetic prophylaxis.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States