Observational Study of Delayed Nausea and Vomiting

NCT00696280 | Completed

• 1 other identifier: 06-0981 / 201104043
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Vomiting

Keywords

nausea; vomiting; Carboplatin; cancer; delayed emesis following treatment with carboplatin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

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

  After 3rd cycle of chemotherapy

• 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

• Assess the need for breakthrough nausea and vomiting control in patients following administration of carboplatin-containing chemotherapy regimens

  Through the end of 3 cycles of therapy

Study Arms (1)

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.

Behavioral: Functional Living Index - Emesis

Interventions

Functional Living Index - Emesis BEHAVIORAL

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have received one treatment of carboplatin

You may qualify if:

• 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.

You may not qualify if:

• No prior cytotoxic chemotherapy within the last 5 years.
• Should not be pregnant.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (13)

• 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.

  PMID: 4045527 BACKGROUND

• 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.

  PMID: 16280105 BACKGROUND

• 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.

  PMID: 7636532 BACKGROUND

• 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.

  PMID: 8996130 BACKGROUND

• 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.

  PMID: 8692551 BACKGROUND

• 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.

  PMID: 9261525 BACKGROUND

• 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.

  PMID: 14559886 BACKGROUND

• 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.

  PMID: 12784346 BACKGROUND

• 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.

  PMID: 1299465 BACKGROUND

• 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.

  PMID: 12827483 BACKGROUND

• 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.

  PMID: 6374052 BACKGROUND

• 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.

  PMID: 12826042 BACKGROUND

• 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.

  PMID: 12697943 RESULT

Related Links

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

MeSH Terms

Conditions

Vomiting; Nausea; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Q Baggstrom, M.D.

  Washington University School of Mecicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 12, 2008
• Study Start: November 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

US (1)