Chemoradiation-Induced Nausea and Emesis: Quality of Life

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Brief Title

Chemoradiation-Induced Nausea and Emesis: Quality of Life

Official Title

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

Brief Summary

      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

        2. To longitudinally assess the quality of life of cancer patients scheduled to receive

        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.

Detailed Description

      You will be interviewed about your perceptions of side effects that are related to your
      chemoradiation treatment. The interview will take about 20 minutes. You will be interviewed
      at the beginning of your chemoradiation treatment, 3 weeks after treatment starts, and at the
      first follow-up appointment after chemoradiation treatment ends.

      Chemoradiation is a type of cancer treatment that involves both chemotherapy and radiation

      You will also receive a packet of 3 questionnaires to complete at different times during and
      after treatment. The questionnaires include a quality of life survey that asks about
      physical, social, and emotional well-being, a self-report symptom evaluation that will ask
      whether you are experiencing any particular side effects and if so how much it bothers you,
      and a brief survey to asks questions about anxiety and distress.

      The questionnaires should take about 20 minutes each to complete. The questionnaire packet
      will be given to patients at the beginning of chemoradiation treatment, 3 weeks after
      treatment starts, the last day of treatment, and at the first follow-up appointment after
      chemoradiation treatment ends. If the you do not have time to complete the questionnaires, a
      stamped, addressed envelop will be given so that you can mail the completed packet back to
      the research team.

      Your participation in this research study will be over about 4-6 weeks after chemoradiation
      treatment ends.

      This is an investigational study. Up to 208 individuals (104 patients and 104 caregivers)
      will take part in this study. All will be enrolled at M. D. Anderson.

Study Type


Primary Outcome

Longitudinal Quality of Life + Symptom Assessment Data


Gastric Cancer



Study Arms / Comparison Groups

Description:  Patients receiving chemoradiation for abdominal-pelvic tumors.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

April 7, 2004

Completion Date

May 8, 2019

Primary Completion Date

May 8, 2019

Eligibility 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




18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Charlotte C. Sun, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

M.D. Anderson Cancer Center


 Merck Sharp & Dohme Corp.

Study Sponsor

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

Verification Date

December 2019