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

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Trial Information

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

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.

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

Exclusion Criteria:

- No prior cytotoxic chemotherapy within the last 5 years.

- Should not be pregnant.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens

Outcome Description:

Despite appropriate administration of standard 5-HT3 receptor antagonist antiemetic prophylaxis after the first cycle of chemotherapy.

Outcome Time Frame:

After 1st cycle of chemotherapy

Safety Issue:


Principal Investigator

Maria Q Baggstrom, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Mecicine


United States: Institutional Review Board

Study ID:

06-0981 / 201104043



Start Date:

November 2006

Completion Date:

November 2009

Related Keywords:

  • Vomiting
  • nausea
  • vomiting
  • Carboplatin
  • cancer
  • delayed emesis following treatment with carboplatin
  • Nausea
  • Vomiting



Washington University School of Medicine Saint Louis, Missouri  63110