Observational Study of Delayed Nausea and Vomiting (DelayedNaus)
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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.
| Condition |
|---|
|
Vomiting |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Observational Study of Delayed Nausea and Vomiting Following Administration of Carboplatin-containing Regimens for Treatment of Cancer |
| Enrollment: | 101 |
| Study Start Date: | November 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
patients whao have received one treatment of carboplatin
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.
Contacts and Locations| United States, Missouri | |
| Washington University School of medicine | |
| St. Louis, Missouri, United States, 63118 | |
| Principal Investigator: | Maria Q Baggstrom, M.D. | Washington University School of Mecicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00696280 History of Changes |
| Other Study ID Numbers: | 06-0981 / 201104043, delayed nausea and vomiting |
| Study First Received: | June 9, 2008 |
| Last Updated: | September 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
nausea vomiting Carboplatin cancer delayed emesis following treatment with carboplatin |
Additional relevant MeSH terms:
|
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms |
Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013