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NCT00716157 Clinical Trial

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

Cancer of the Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00716157
Other study ID # 04C.466
Secondary ID 2004-16100200402
Status Completed
Phase N/A
First received July 14, 2008
Last updated December 3, 2014
Start date October 2004
Est. completion date September 2011

Study information
Verified date December 2014
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 2011
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Concurrent radiation and chemotherapy treatment

- Aerodigestive malignancy

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Thomas Jefferson University Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation week of treatment No
Secondary Assess the impact of nausea and vomiting on the patients' daily functioning week of treatment No
Secondary Study the incidence of mucositis and esophagitis week of treatment No
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