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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lisa Biondo, West Virginia University Healthcare
ClinicalTrials.gov Identifier:
NCT01757210
First received: September 27, 2012
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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.


Condition
Chemotherapy-Induced Nausea and Vomiting

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by West Virginia University Healthcare:

Primary Outcome Measures:
  • Number of episodes of nausea and vomiting [ Time Frame: Five days after end of chemotherapy ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Appetite score on a 4-point Likert scale [ Time Frame: Five days after the end of chemotherapy ] [ Designated as safety issue: No ]
    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

  • Activities of daily living score on a 4-point Likert scale [ Time Frame: Five days after the end of chemotherapy ] [ Designated as safety issue: No ]
    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

  • Number of medications used for breakthrough nausea and vomiting [ Time Frame: Five days after the end of chemotherapy ] [ Designated as safety issue: No ]
    The usage of all breakthrough medications for chemotherapy-induced nausea and vomiting while in the hospital will be recorded.

  • Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Five days after the end of chemotherapy ] [ Designated as safety issue: No ]
    Incidence of adverse events that can be definitely or probably related to aprepitant using the Naranjo Adverse Event Scale.


Enrollment: 20
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will include pediatric patients with an active malignancy.

Criteria

Inclusion Criteria:

  1. Patient is between the ages of 1-17 years
  2. Patient has a confirmed malignancy
  3. Patient is receiving highly or moderately emetogenic chemotherapy
  4. Receiving aprepitant as part of an anti-emetic regimen
  5. 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.
  6. 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:

  1. Pregnant or breast feeding
  2. Concomitant use of pimozide, terfenadine, astemizole, or cisapride
  3. Child-Pugh score > 9
  4. Receiving IV fosaprepitant
  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: NCT01757210

Locations
United States, West Virginia
WVU Healthcare
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University Healthcare
Investigators
Principal Investigator: Lisa Biondo, Pharm.D. WVU Healthcare
  More Information

Publications:
Responsible Party: Lisa Biondo, Pharm.D., BCPS, West Virginia University Healthcare
ClinicalTrials.gov Identifier: NCT01757210     History of Changes
Other Study ID Numbers: 24267
Study First Received: September 27, 2012
Last Updated: August 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University Healthcare:
Aprepitant
Pediatrics
Chemotherapy-induced nausea/vomiting
Survey

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014