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NCT Number: NCT01757210

A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients

Aprepitant was approved in 2003. The drug works to lessen the amount of nausea and vomiting that cancer patients experience after treatment. Aprepitant has been well-studied in adults, but not in children. Data from adult studies has shown aprepitant to be safe. It has also been shown to be effective in lessening the amount of nausea and vomiting that adult patients experience. Because aprepitant has been shown to be safe and effective, the investigators have been using it in pediatric patients at this hospital as standard of care. The investigators will be surveying patients already receiving aprepitant for prevention of chemotherapy-induced nausea and vomiting to determine the amount of nausea and vomiting they experience. The investigators will also be surveying these patients to determine what their appetite is like and if they experience any disruptions in activities of daily living. The investigators are also going to be assessing any side effects these patients experience from receiving aprepitant.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

WVU Healthcare

Morgantown, West Virginia, 26506, United States

About this study

This will be a prospective, observational study conducted at WVU Children´s Hospital. The study will be conducted over a one-year period until data from 20-40 patient encounters is obtained. There will be no randomization and no control group. Information will be collected from all patients who meet the study´s inclusion criteria. Patients will be given a survey to complete at baseline, on all days of chemotherapy, and for five days after the conclusion of chemotherapy using the BARF Scale and a 4-point Likert scale. The information collected from the survey will include the incidence and severity of nausea and emesis, evaluation of appetite, activities of daily living, and rescue medications used for acute CINV. The specific chemotherapy regimen that each patient receives will be recorded. Any data identifying the patient will be de-identified after all pertinent data is collected. Descriptive statistics will be used to analyze data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is between the ages of 1-17 years
  • Patient has a confirmed malignancy
  • Patient is receiving highly or moderately emetogenic chemotherapy
  • Receiving aprepitant as part of an anti-emetic regimen
  • Patient's legally-authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
  • Patient ≥7 years of age understands and voluntarily signs the written informed assent form prior to any study specific procedures. A copy of the signed informed assent form will be retained by the treating institution.

Exclusion criteria

  • Pregnant or breast feeding
  • Concomitant use of pimozide, terfenadine, astemizole, or cisapride
  • Child-Pugh score > 9
  • Receiving IV fosaprepitant

Treatment and study plan

Primary outcomes

  1. Number of episodes of nausea and vomiting

    Time frame: Five days after end of chemotherapy

    The primary outcome measure is assessing the incidence of chemotherapy-induced nausea and vomiting in pediatric patients receiving highly or moderately emetogenic chemotherapy and a prophylactic regimen that includes aprepitant. The incidence of chemotherapy-induced nausea and vomiting will be evaluated using the BARF Scale and a 4-point Likert scale on all days of chemotherapy and for five days following the conclusion of chemotherapy compared to baseline

Secondary outcomes

  1. Appetite score on a 4-point Likert scale

    Time frame: Five days after the end of chemotherapy

    Patients will be assessed for changes in appetite using a 4-point Likert scale at baseline, on all days of chemotherapy, and for the five days following the conclusion of chemotherapy

  2. Activities of daily living score on a 4-point Likert scale

    Time frame: Five days after the end of chemotherapy

    Patients will be assessed for changes in activities of daily living using a 4-point Likert scale at baseline, on all days of chemotherapy, and for five days following the conclusion of chemotherapy

  3. Number of medications used for breakthrough nausea and vomiting

    Time frame: Five days after the end of chemotherapy

    The usage of all breakthrough medications for chemotherapy-induced nausea and vomiting while in the hospital will be recorded.

  4. Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Five days after the end of chemotherapy

    Incidence of adverse events that can be definitely or probably related to aprepitant using the Naranjo Adverse Event Scale.

Sponsors and collaborators

Lead sponsor

West Virginia University Healthcare

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 28, 2012
Registry last updated
Aug 22, 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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