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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00716157
First received: July 14, 2008
Last updated: August 9, 2012
Last verified: August 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the impact of nausea and vomiting on the patients' daily functioning [ Time Frame: week of treatment ] [ Designated as safety issue: No ]
  • Study the incidence of mucositis and esophagitis [ Time Frame: week of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00716157     History of Changes
Other Study ID Numbers: 04C.466, 2004-16, 1002004024
Study First Received: July 14, 2008
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014