Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation

December 3, 2014 updated by: Thomas Jefferson University

A Prospective Study to Evaluate the Incidence and Patterns of Nausea and Vomiting in Patients Receiving Combined Chemotherapy and Radiation

Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients receiving combined chemotherapy and radiation. 83% of patients experience radiation therapy-induced vomiting; significant nausea and vomiting could develop with concurrent chemotherapy despite standard anti-nauseous medication prophylaxis.

Study Overview

Status

Completed

Conditions

Detailed Description

Questionnaires will be answered daily on a weekly basis during period of radiation and chemotherapy.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

University practice patients with aerodigestive malignancy

Description

Inclusion Criteria:

  • Concurrent radiation and chemotherapy treatment
  • Aerodigestive malignancy

Exclusion Criteria:

  • Other causes of vomiting (i.e.gastrointestinal obstruction...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observation
Adult patients receiving both radiation therapy and chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation
Time Frame: week of treatment
week of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the impact of nausea and vomiting on the patients' daily functioning
Time Frame: week of treatment
week of treatment
Study the incidence of mucositis and esophagitis
Time Frame: week of treatment
week of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Rita Axelrod, MD, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04C.466
  • 2004-16 (Other Identifier: CCRRC)
  • 1002004024 (Other Grant/Funding Number: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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