AzTrials
AzTrials

Chemotherapy-Induced Nausea and VomitingNCT01757210

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

An observational study of Chemotherapy-Induced Nausea and Vomiting, run by West Virginia University Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Chemotherapy-Induced Nausea and Vomiting
How many people
20 participants
Where
1 siteUnited States
Study dates
Sep 2012to Aug 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: This study will include pediatric patients with an active malignancy.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • WVU Healthcare

    Morgantown, West Virginia, 26506

Other trials in United States

About this study

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.

Read the 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.

Keywords
Aprepitant, Pediatrics, Chemotherapy-induced nausea/vomiting, Survey
Medical subject headings
Vomiting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of episodes of nausea and vomiting

    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

    Measured: Five days after end of chemotherapy

Secondary outcomes (4)

  1. Appetite score on a 4-point Likert scale

    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

    Measured: Five days after the end of chemotherapy

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

    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

    Measured: Five days after the end of chemotherapy

  3. Number of medications used for breakthrough nausea and vomiting

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

    Measured: Five days after the end of chemotherapy

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

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

    Measured: Five days after the end of chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01757210
Sponsor's protocol ID
24267
Status last verified
Aug 2013
First submitted
27 Sep 2012
Last updated
22 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Smith AR, Repka TL, Weigel BJ. Aprepitant for the control of chemotherapy induced nausea and vomiting in adolescents. Pediatr Blood Cancer. 2005 Nov;45(6):857-60. doi: 10.1002/pbc.20378.

    PubMed 15849684

  • Choi MR, Jiles C, Seibel NL. Aprepitant use in children, adolescents, and young adults for the control of chemotherapy-induced nausea and vomiting (CINV). J Pediatr Hematol Oncol. 2010 Oct;32(7):e268-71. doi: 10.1097/MPH.0b013e3181e5e1af.

    PubMed 20736848

  • Gore L, Chawla S, Petrilli A, Hemenway M, Schissel D, Chua V, Carides AD, Taylor A, Devandry S, Valentine J, Evans JK, Oxenius B; Adolescent Aprepitant in Cancer Study Group. Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. Pediatr Blood Cancer. 2009 Feb;52(2):242-7. doi: 10.1002/pbc.21811.

    PubMed 18985740

Questions about this trial

What is this clinical trial studying?

An observational study of Chemotherapy-Induced Nausea and Vomiting, run by West Virginia University Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of episodes of nausea and vomiting (time frame: Five days after end of chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01757210, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in