Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00502502
First received: July 16, 2007
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

Primary Objectives:

  • To determine the feasibility of a study that would describe changes of certain circulating inflammatory cytokines (interleukin-1, 6, 8, 10, 12, and tumor necrosis factor-alpha [TNF] and symptoms related to chemoradiation therapy (pre-therapy, during therapy and up to 3 months post-therapy) among patients with lung, esophageal, gastric, colorectal and anal cancer.
  • To determine the feasibility of studying neurocognitive function in patients with non-small cell lung cancer (NSCLC) at presentation and during chemoradiation therapy to determine the prevalence, severity, and pattern of cognitive symptoms.

Condition Intervention
Anal Cancer
Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Lung Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility Study of the Assessment of Symptom-Related Cytokines in Lung and GI Cancer Patients Undergoing Chemoradiation Therapy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Symptom Assessment (Questionnaire) [ Time Frame: Weekly for 1-3 months post-therapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples will be collected to study the levels of cytokines in your blood.


Enrollment: 205
Study Start Date: November 2002
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Symptom-Related Cytokines Questionnaire Behavioral: Questionnaire
Weekly questionnaires lasting about 30 minutes.
Other Name: Survey

Detailed Description:

One of the ways to learn about the symptoms of chemoradiation therapy is by looking at how certain proteins called cytokines (found in the blood) change during therapy. Another way is to look at how thinking and memory may be changed because of treatment.

Before therapy starts, you will be asked to complete several questionnaires during a visit to the Radiation Oncology clinic at M. D. Anderson. These questionnaires measure physical and emotional symptoms. These questionnaires should take about 30 minutes to finish. Lung cancer patients will also complete some cognitive (mental) questionnaires. During this visit, the research nurse will teach you how to use the telephone system for measuring symptoms. You will tell the system the most convenient times for the telephone calls. The date of the call will be at the same or close to the date of your weekly clinic visit.

Before you begin your chemoradiation treatments, you will have a sample of blood drawn (around 2½ tablespoons). The sample of blood will be used to measure levels of cytokines in your blood pre treatment.

You will have about 2½ tablespoons of blood drawn again when you start chemoradiation, and then once a week while you are receiving treatment. These cytokines may be related to symptoms experienced while having treatment for cancer. These blood tests are being done to study the levels of cytokines in your blood during, and after treatment for cancer.

Symptoms will be monitored weekly using an interactive voice response telephone system. During chemoradiation, the automated telephone system will call you once a week to ask you to rate your symptoms and how much the symptoms interfere in your daily life. The information collected by these calls is only being used for this research study.

At the end of the chemoradiation, lung cancer patients will again be given questionnaires to measure cognitive symptoms.

For lung cancer patients who are post-chemotherapy, your symptoms will be monitored weekly for 3 months after therapy using the interactive voice response telephone system. For esophageal, gastric, colorectal, and anal patients who are post-therapy, your symptoms will be monitored weekly for 6 weeks after therapy using the interactive voice response telephone system. About 30 days after chemoradiation, you will have 2½ tablespoons of blood drawn at your regularly scheduled clinic visit. If you are not scheduled for a 3 month clinic visit, we will contact your local physician for blood lab results.

This is an investigational study. About 225 evaluable patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study participants with lung, esophageal, gastric, colorectal or anal cancer.

Criteria

Inclusion Criteria:

  1. Patients scheduled for chemoradiation therapy at MDACC.
  2. Adults > 18 years of age.
  3. Diagnosis of lung, esophageal, gastric, colorectal, or anal cancer.
  4. English-speaking.
  5. Lives in the United States.
  6. Adequate vision and hearing to use the IVR system.
  7. Provides written informed consent.

Exclusion Criteria:

  1. Patients with a current diagnosis of psychosis or dementia.
  2. Patients who are unable to complete the assessment measures or refuse to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502502

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Xin Shelley Wang, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502502     History of Changes
Other Study ID Numbers: ANS02-495
Study First Received: July 16, 2007
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Anal Cancer
Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Lung Cancer
Questionnaire
Survey
Chemoradiation Therapy
Symptoms
Cytokines

Additional relevant MeSH terms:
Anus Neoplasms
Colorectal Neoplasms
Esophageal Neoplasms
Lung Neoplasms
Stomach Neoplasms
Anus Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Stomach Diseases
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014