Chemoradiation-Induced Nausea and Emesis: Quality of Life

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00394602
• Other study ID #: 2003-0529
• Status: Terminated
• Start date: April 7, 2004
• Est. completion date: May 8, 2019

Study information

• Verified date: December 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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 therapy.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 207
• Est. completion date: May 8, 2019
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Gastric Cancer
• Nausea
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms
• Uterine Cervical Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Behavioral:
• Interview
Interview regarding perceptions of side effects that are related to chemoradiation treatment.

Other:
• Questionnaire
3 Questionnaires regarding quality of life given during and after treatment, each taking about 20 minutes to complete.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal Quality of Life + Symptom Assessment Data	Quality of life survey instruments scored according to EORTC QLQ-C30 scoring manual. Patients and controls compared with respect to preference data. The control group preference data collected at only 1 time point, but patient preference data from each time point will be compared to these control group preference data.	Survey(s) & Interview(s) at baseline (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.

External Links

•   University of Texas MD Anderson Cancer Center Website