Expired Study
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St. Louis, Missouri 63110


Purpose:

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 summary:

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.


Criteria:

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.


NCT ID:

NCT00696280


Primary Contact:

Principal Investigator
Maria Q Baggstrom, M.D.
Washington University School of Mecicine


Backup Contact:

N/A


Location Contact:

St. Louis, Missouri 63110
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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