Observational Study of Delayed Nausea and Vomiting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study of Delayed Nausea and Vomiting Following Administration of Carboplatin Containing Regimens for Treatment of Cancer

Conditions
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Vomiting

Intervention / Treatment
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* Behavioral: Functional Living Index - Emesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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. | Behavioral: Functional Living Index - Emesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens | Despite appropriate administration of standard antiemetic prophylaxis after the third cycle of chemotherapy | After 3rd 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 | Despite appropriate administration of standard antiemetic prophylaxis. | Through the end of 3 cycles of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea, vomiting, Carboplatin, cancer, delayed emesis following treatment with carboplatin