Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objectives:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptom-Related Cytokines Questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Weekly questionnaires lasting about 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Symptom Assessment (Questionnaire) | Weekly for 1-3 months post-therapy |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Study participants with lung, esophageal, gastric, colorectal or anal cancer.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xin Shelley Wang, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples will be collected to study the levels of cytokines in your blood.
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |