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

NCT ID: NCT00716157

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation

Adult patients receiving both radiation therapy and chemotherapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Concurrent radiation and chemotherapy treatment
* Aerodigestive malignancy

Exclusion Criteria

* Other causes of vomiting (i.e.gastrointestinal obstruction...)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rita Axelrod, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2004-16

Identifier Type: OTHER

Identifier Source: secondary_id

1002004024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

04C.466

Identifier Type: -

Identifier Source: org_study_id