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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00716157
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : December 5, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
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.

Condition or disease
Cancer of the Head and Neck Cancer of the Lung Cancer of the Esophagus Gastro-esophageal Junction Cancer

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

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study to Evaluate the Incidence and Patterns of Nausea and Vomiting in Patients Receiving Combined Chemotherapy and Radiation
Study Start Date : October 2004
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Adult patients receiving both radiation therapy and chemotherapy

Primary Outcome Measures :
  1. Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation [ Time Frame: week of treatment ]

Secondary Outcome Measures :
  1. Assess the impact of nausea and vomiting on the patients' daily functioning [ Time Frame: week of treatment ]
  2. Study the incidence of mucositis and esophagitis [ Time Frame: week of treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
University practice patients with aerodigestive malignancy

Inclusion Criteria:

  • Concurrent radiation and chemotherapy treatment
  • Aerodigestive malignancy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716157

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Merck Sharp & Dohme Corp.
Principal Investigator: Rita Axelrod, MD Thomas Jefferson University

Responsible Party: Thomas Jefferson University Identifier: NCT00716157     History of Changes
Other Study ID Numbers: 04C.466
2004-16 ( Other Identifier: CCRRC )
1002004024 ( Other Grant/Funding Number: Merck )
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Head and Neck Neoplasms
Esophageal Neoplasms
Lung Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms by Site
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases