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Completed

NCT Number: NCT00696280

Observational Study of Delayed Nausea and Vomiting

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.

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Key information

Conditions

Vomiting Nausea Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Living Index - Emesis

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: DelayedNaus

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2008
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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