Observational Study of Delayed Nausea and Vomiting (DelayedNaus)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00696280
First received: June 9, 2008
Last updated: June 11, 2013
Last verified: June 2013
  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 Intervention
Vomiting
Behavioral: Functional Living Index - Emesis

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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens [ Time Frame: After 1st cycle of chemotherapy ] [ Designated as safety issue: No ]
    Despite appropriate administration of standard 5-HT3 receptor antagonist antiemetic prophylaxis after the first cycle of chemotherapy.


Secondary Outcome Measures:
  • Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens [ Time Frame: After 3rd cycle of chemotherapy ] [ Designated as safety issue: No ]
    Despite appropriate administration of standard antiemetic prophylaxis after the third cycle of chemotherapy

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Despite appropriate administration of standard antiemetic prophylaxis.


Enrollment: 106
Study Start Date: November 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have received one treatment of carboplatin

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696280

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Merck Sharp & Dohme Corp.
Investigators
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
Study First Received: June 9, 2008
Last Updated: June 11, 2013
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:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014