Anal CancerNCT00502502
Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients
An observational study of Anal Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer, Colorectal Cancer, Esophageal Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants with lung, esophageal, gastric, colorectal or anal cancer.
Who may be able to join
- Patients scheduled for chemoradiation therapy at MDACC.
- Adults > 18 years of age.
- Diagnosis of lung, esophageal, gastric, colorectal, or anal cancer.
- English-speaking.
- Lives in the United States.
- Adequate vision and hearing to use the IVR system.
- Provides written informed consent.
Who cannot join
- Patients with a current diagnosis of psychosis or dementia.
- Patients who are unable to complete the assessment measures or refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of the Assessment of Symptom-Related Cytokines in Lung and GI Cancer Patients Undergoing Chemoradiation Therapy
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.
Read the 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.
- Conditions
- Anal Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Lung Cancer
- Being tested
- Questionnaire
- Keywords
- Anal Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Lung Cancer, Questionnaire, Survey, Chemoradiation Therapy, Symptoms, Cytokines
- Medical subject headings
- Anus Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Weekly questionnaires lasting about 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Symptom-Related Cytokines Questionnaire | Not described Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Symptom Assessment (Questionnaire)
Measured: Weekly for 1-3 months post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startNov 2002
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Xin Shelley Wang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502502
- Sponsor's protocol ID
- ANS02-495
- Status last verified
- Jul 2012
- First submitted
- 16 Jul 2007
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Assessment of Symptom-Related Cytokines in Lung and GI Cancer Patients Undergoing Chemoradiation Therapy
- ClinicalTrials.gov ID
- NCT00502502
- Acronym / sponsor ID
- ANS02-495
- Conditions
- Anal Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Lung Cancer
- Keywords
- Anal Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Lung Cancer, Questionnaire, Survey, Chemoradiation Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2002
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptom-Related Cytokines Questionnaire | – | Behavioral: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants with lung, esophageal, gastric, colorectal or anal cancer.
Key inclusion criteria (7 listed)
- Patients scheduled for chemoradiation therapy at MDACC.
- Adults > 18 years of age.
- Diagnosis of lung, esophageal, gastric, colorectal, or anal cancer.
- English-speaking.
- Lives in the United States.
Key exclusion criteria (2 listed)
- Patients with a current diagnosis of psychosis or dementia.
- Patients who are unable to complete the assessment measures or refuse to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyWeekly questionnaires lasting about 30 minutes. | Behavioural | Symptom-Related Cytokines Questionnaire |
Primary outcome
Patient Symptom Assessment (Questionnaire)
Time frame: Weekly for 1-3 months post-therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Shelley Wang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Symptom Assessment (Questionnaire) (time frame: Weekly for 1-3 months post-therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2012.