Clinical trial NCT00696280: Observational Study of Delayed Nausea and Vomiting
Official title: Observational Study of Delayed Nausea and Vomiting Following Administration of Carboplatin Containing Regimens for Treatment of Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vomiting
Keywords: nausea
vomiting
Carboplatin
cancer
delayed emesis following treatment with carboplatin
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-06-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received one treatment of carboplatin

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.

Eligibility 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.

Primary outcomes:
measure: Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens
timeFrame: After 1st cycle of chemotherapy
Secondary outcomes:
measure: Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens
timeFrame: After 3rd cycle of chemotherapy
measure: Characterize the differences in incidence of delayed nausea and vomiting among male and female patients receiving carboplatin.
timeFrame: Through the end of 3 cycles of therapy
measure: Assess the need for breakthrough nausea and vomiting control in patients following administration of carboplatin-containing chemotherapy regimens
timeFrame: Through the end of 3 cycles of therapy
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Mecicine
name: Maria Q Baggstrom, M.D.
role: PRINCIPAL_INVESTIGATOR
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