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Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life

This study is currently Recruiting

July 2011 By M.D. Anderson Cancer Center

First Recieved on October 30, 2006

Last Updated on July 27, 2011

Sponsor: M.D. Anderson Cancer Center
Collaborators: Merck
Information provided by: M.D. Anderson Cancer Center
Identifier: NCT00394602

Purpose

The primary objectives of this study are: 1. To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation. 1. To compare preferences of cancer patients to those of healthy individuals. 2. To compare how patients' preferences for side-effects of chemoradiation change over time. 2. To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation. 3. To determine the impact of nausea and vomiting associated with chemoradiation on patients' quality of life and evaluate potential change throughout the duration of chemoradiation treatment.

Study Type: Observational
Study Design: Observational Model: Case Control, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: 1. Patients receiving 5 to 6-week course of chemoradiation for abdominal-pelvic tumors (gastric cancers, gastro-esophageal (GE) junction, pancreatic, cervix, vulvar, endometrial, or anal) using conventional fractionation [(180cGy-200cGy per day)] 2. Patients receiving concurrent abdominal-pelvic radiation and single agent or combination of cisplatin, paclitaxel, CPT-11, oxaliplatin or 5-FU, capecitabine, gemcitabine, or bevacizumab (Avastin). 3. Patients must be least 18 years of age 4. Controls must be individuals with no prior cancer diagnosis 5. Controls must be at least 18 years of age 6. Controls must be the caregivers of patients on this study Exclusion Criteria: 1. Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer 2. Patients who are not scheduled to receive chemoradiation treatment 3. Patients who are not at least 18 years of age 4. Controls - individuals who have a prior diagnosis of cancer (with the exception of non-melanoma skin cancer) 5. Controls - individuals who are not at least 18 years of age

Investigators

  • Investigator: Charlotte C. Sun, MD - Principal Investigator - M.D. Anderson Cancer Center

Locations

  • UT MD Anderson Cancer Center

    Houston, Texas 77030 United States

Conditions related to this trial:

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