- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696280
Observational Study of Delayed Nausea and Vomiting (DelayedNaus)
Observational Study of Delayed Nausea and Vomiting Following Administration of Carboplatin Containing Regimens for Treatment of Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens
Time Frame: After 1st cycle of chemotherapy
|
Despite appropriate administration of standard 5-HT3 receptor antagonist antiemetic prophylaxis after the first cycle of chemotherapy.
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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
Time Frame: After 3rd cycle of chemotherapy
|
Despite appropriate administration of standard antiemetic prophylaxis after the third cycle of chemotherapy
|
After 3rd cycle of chemotherapy
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Characterize the differences in incidence of delayed nausea and vomiting among male and female patients receiving carboplatin.
Time Frame: Through the end of 3 cycles of therapy
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Through the end of 3 cycles of therapy
|
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Assess the need for breakthrough nausea and vomiting control in patients following administration of carboplatin-containing chemotherapy regimens
Time Frame: Through the end of 3 cycles of therapy
|
Despite appropriate administration of standard antiemetic prophylaxis.
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Through the end of 3 cycles of therapy
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maria Q Baggstrom, M.D., Washington University School of Mecicine
Publications and helpful links
General Publications
- Martin AR, Pearson JD, Cai B, Elmer M, Horgan K, Lindley C. Assessing the impact of chemotherapy-induced nausea and vomiting on patients' daily lives: a modified version of the Functional Living Index-Emesis (FLIE) with 5-day recall. Support Care Cancer. 2003 Aug;11(8):522-7. doi: 10.1007/s00520-003-0482-4. Epub 2003 Jun 25.
- Kris MG, Gralla RJ, Clark RA, Tyson LB, O'Connell JP, Wertheim MS, Kelsen DP. Incidence, course, and severity of delayed nausea and vomiting following the administration of high-dose cisplatin. J Clin Oncol. 1985 Oct;3(10):1379-84. doi: 10.1200/JCO.1985.3.10.1379.
- Ettinger D, Johnson B. Update: NCCN small cell and non-small cell lung cancer Clinical Practice Guidelines. J Natl Compr Canc Netw. 2005 Nov;3 Suppl 1:S17-21. No abstract available.
- Raby B, Pater J, Mackillop WJ. Does knowledge guide practice? Another look at the management of non-small-cell lung cancer. J Clin Oncol. 1995 Aug;13(8):1904-11. doi: 10.1200/JCO.1995.13.8.1904.
- Hesketh PJ, Kris MG, Grunberg SM, Beck T, Hainsworth JD, Harker G, Aapro MS, Gandara D, Lindley CM. Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol. 1997 Jan;15(1):103-9. doi: 10.1200/JCO.1997.15.1.103.
- du Bois A, Vach W, Kiechle M, Cramer-Giraud U, Meerpohl HG. Pathophysiology, severity, pattern, and risk factors for carboplatin-induced emesis. Oncology. 1996 Jun;53 Suppl 1:46-50. doi: 10.1159/000227640.
- Delayed emesis induced by moderately emetogenic chemotherapy: do we need to treat all patients? The Italian Group for Antiemetic Research. Ann Oncol. 1997 Jun;8(6):561-7.
- Hesketh PJ, Grunberg SM, Gralla RJ, Warr DG, Roila F, de Wit R, Chawla SP, Carides AD, Ianus J, Elmer ME, Evans JK, Beck K, Reines S, Horgan KJ; Aprepitant Protocol 052 Study Group. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group. J Clin Oncol. 2003 Nov 15;21(22):4112-9. doi: 10.1200/JCO.2003.01.095. Epub 2003 Oct 14.
- Poli-Bigelli S, Rodrigues-Pereira J, Carides AD, Julie Ma G, Eldridge K, Hipple A, Evans JK, Horgan KJ, Lawson F; Aprepitant Protocol 054 Study Group. Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Results from a randomized, double-blind, placebo-controlled trial in Latin America. Cancer. 2003 Jun 15;97(12):3090-8. doi: 10.1002/cncr.11433.
- Lindley CM, Hirsch JD, O'Neill CV, Transau MC, Gilbert CS, Osterhaus JT. Quality of life consequences of chemotherapy-induced emesis. Qual Life Res. 1992 Oct;1(5):331-40. doi: 10.1007/BF00434947.
- Schipper H, Clinch J, McMurray A, Levitt M. Measuring the quality of life of cancer patients: the Functional Living Index-Cancer: development and validation. J Clin Oncol. 1984 May;2(5):472-83. doi: 10.1200/JCO.1984.2.5.472.
- Martin AR, Carides AD, Pearson JD, Horgan K, Elmer M, Schmidt C, Cai B, Chawla SP, Grunberg SM. Functional relevance of antiemetic control. Experience using the FLIE questionnaire in a randomised study of the NK-1 antagonist aprepitant. Eur J Cancer. 2003 Jul;39(10):1395-401. doi: 10.1016/s0959-8049(03)00299-5.
- Schnell FM. Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control. Oncologist. 2003;8(2):187-98. doi: 10.1634/theoncologist.8-2-187.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-0981 / 201104043
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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