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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716157
First Posted: July 16, 2008
Last Update Posted: December 5, 2014
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Jefferson University
  Purpose
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
Cancer of the Head and Neck Cancer of the Lung Cancer of the Esophagus Gastro-esophageal Junction Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

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

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

Estimated Enrollment: 40
Study Start Date: October 2004
Study Completion Date: September 2011
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Adult patients receiving both radiation therapy and chemotherapy

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

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Concurrent radiation and chemotherapy treatment
  • Aerodigestive malignancy

Exclusion Criteria:

  • Other causes of vomiting (i.e.gastrointestinal obstruction...)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00716157


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

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00716157     History of Changes
Other Study ID Numbers: 04C.466
2004-16 ( Other Identifier: CCRRC )
1002004024 ( Other Grant/Funding Number: Merck )
First Submitted: July 14, 2008
First Posted: July 16, 2008
Last Update Posted: December 5, 2014
Last Verified: December 2014

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