Observational Study of Delayed Nausea and Vomiting

Vomiting Clinical Trial

— DelayedNaus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696280
• Other study ID #: 06-0981 / 201104043
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: June 11, 2013
• Start date: November 2006
• Est. completion date: November 2009

Study information

• Verified date: June 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Vomiting

Intervention

Behavioral:
• Functional Living Index - Emesis

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2003 Oct 14. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2003 Jun 25. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Schnell FM. Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control. Oncologist. 2003;8(2):187-98. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens	Despite appropriate administration of standard 5-HT3 receptor antagonist antiemetic prophylaxis after the first cycle of chemotherapy.	After 1st cycle of chemotherapy	No
Secondary	Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens	Despite appropriate administration of standard antiemetic prophylaxis after the third cycle of chemotherapy	After 3rd cycle of chemotherapy	No
Secondary	Characterize the differences in incidence of delayed nausea and vomiting among male and female patients receiving carboplatin.		Through the end of 3 cycles of therapy	No
Secondary	Assess the need for breakthrough nausea and vomiting control in patients following administration of carboplatin-containing chemotherapy regimens	Despite appropriate administration of standard antiemetic prophylaxis.	Through the end of 3 cycles of therapy	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine