Lung Cancer Clinical Trial; Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer

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Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, October 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00422500

Purpose
Primary Objectives:

To compare the severity of symptoms, their impact on affective and health-related functional status, and symptom interference among patients with advanced-stage lung cancer following initiation of chemotherapy by disease status, tumor response to chemotherapy, and adequacy of symptom management.
To examine the relationship of disease-related and treatment-related physical symptoms to affective impairment and the patient's reported symptom interference and functional impairment.
To compare symptom severity, adequacy of symptom management, and interference with affective status and health-related function by patient's minority status.
To explore the serum level of inflammatory cytokines during chemotherapy among lung cancer patients.
To measure DNA repair capacity (DRC) in lymphocyte cultures of all patients enrolled in the protocol at baseline (before treatment) and during each follow-up blood draw. The hypothesis is that patients with suboptimal DRC will do better with chemotherapy than patients with efficient DRC.
To extract DNA and genotype for polymorphisms in genes involved in the nucleotide excision repair pathway and in those involved in response to pain (opioid receptors, dopamine receptors, COMT). We hypothesize that:

Polymorphisms in NER genes that modulate DNA repair capacity will also effect response to chemotherapy and to outcome.
Cytokine gene polymorphisms account for variations in symptom outcomes (specific symptoms and symptom clusters) before, during and after chemotherapy.
The COMT val/met polymorphism affects the metabolism of catecholamines on the modulation of response to sustained pain.
Dopamine receptor polymorphisms that result in decreased density of dopamine receptors will result in a deficit in the dopamine pathway. that will also affect response to pain.
To evaluate neurocognitive function to determine the prevalence, severity, and pattern of cognitive symptoms.


Condition Intervention
Lung Cancer
Behavioral: Questionnaire
Behavioral: Telephone Interactive System
Other: Blood Samples




MedlinePlus related topics: Cancer Lung Cancer Palliative Care
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Longitudinal Study of the Prevalence, Severity, and Interference of Multiple Symptoms in Advanced Lung Cancer


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


Primary Outcome Measures:
To learn about chemotherapy symptoms in patients with lung cancer. [ Time Frame: 10 Years ] [ Designated as safety issue: No ]



Secondary Outcome Measures:
To test the usefulness of a special telephone system for measuring the symptoms of patients during and following therapy. [ Time Frame: 10 Years ] [ Designated as safety issue: No ]


Biospecimen Retention: Samples With DNA


Biospecimen Description:
Study participants enrolled at M. D. Anderson will have additional serum drawn for cytokine analysis and DNA repair capacity. This blood will be drawn at the routine blood draws before treatment begins, and at the beginning of each treatment cycle.


Estimated Enrollment: 224
Study Start Date: November 2003
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
Study participants with advanced-stage lung cancer. Behavioral: Questionnaire
Surveys about symptoms, mood, and quality of life.
Behavioral: Telephone Interactive System
The automated telephone system will call the participant once a week. Using the numeric key pad on the telephone, the severity of symptoms and how much they interfere with daily life will be rated. Once therapy is complete, the phone system will call every two weeks for up to six months.
Other: Blood Samples
For participating patients, 3 additional tablespoons of blood drawn at the beginning of each chemotherapy treatment (before treatment starts) and at the beginning of each cycle of treatment.


Detailed Description:
One of the ways to learn about the symptoms of chemotherapy is by looking at how certain proteins called cytokines (found in the blood) change during therapy. Another way is to look at how symptoms change during treatment.

Before therapy starts, you will be asked to complete several questionnaires during a visit to the thoracic clinic at M. D. Anderson. These questionnaires measure physical and emotional (mental) symptoms. The questionnaires should take about 60 minutes to finish. You will also be asked to complete some cognitive (mental) questionnaires that take about 25 minutes to complete. During this visit, the research nurse will teach you how to use an interactive voice response telephone system for measuring symptoms. The research nurse will ask you the most convenient time for the telephone calls, and make sure the system is programmed to call you at that time. The date of the call will be at the same or close to the date of your weekly clinic visit.

Symptoms will be monitored weekly during chemotherapy treatment using this interactive voice response telephone system. The automated telephone system will call you once a week, and using the numeric key pad on your telephone, you will rate the severity of your symptoms and how much they interfere in your daily life. Once you complete therapy, the phone system will call every two weeks for up to six months. The information collected by these calls is only being used for this research study.

In addition to the telephone calls, the research nurse will arrange to meet you approximately every 6 weeks at your clinic visit. She will ask you to complete some surveys about your symptoms, mood, and quality of life. This meeting will take about 45 minutes. You will also be asked again to complete some cognitive (mental) questionnaires that take about 25 minutes to complete.

Research staff will also obtain from your medical record clinical information and lab values during your treatment period.

If you have agreed to participate in the companion caregiver study, the study staff will use your demographic and clinical data to study the influence of your symptoms on your caregiver's physical and mental health.

You are encouraged to report your symptoms to your treating physicians during the study, especially if you have any symptom that you rate greater than 7 on the 0 to 10 scale.

This is an investigational study. A total of up to 224 patients will take part in this multicenter study. Up to 112 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: Probability Sample

Study Population
Study participants with advanced-stage lung cancer and disease- or treatment-related symptoms.

Criteria
Inclusion Criteria:

Is an adult > 18 years of age
Is diagnosed with Stage III or IV Lung cancer
Is scheduled for a new chemotherapy regimen. Patients who have received prior chemotherapy are eligible.
Is English- or Spanish-speaking
Currently lives in the United States
Exclusion Criteria:

Does not have access to telephones
Is unable to use the telephone interactive system
Has a current diagnosis of psychosis or dementia
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422500


Contacts
Contact: Xin Shelley Wang, MD 713-745-3470


Locations
United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
United States, Texas
U.T. M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Xin Shelley Wang, MD
Lyndon Baines Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Xin Shelley Wang, MD M.D. Anderson Cancer Center

More Information


UT MD Anderson Cancer Center

Responsible Party: U.T. M.D. Anderson Cancer Institute ( Xin Shelley Wang, MD/Associate Professor )
Study ID Numbers: 2003-0701
Study First Received: January 12, 2007
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00422500 [history]
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Advanced Lung Cancer
Chemotherapy Symptoms
Disease-Related Symptoms
Treatment-Related Symptoms
Symptom Management
Questionnaire
Telephone Interactive System
IVR Telephone System
DNA Repair Capacity
DRC
Cognitive Symptoms



Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neurobehavioral Manifestations



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms



ClinicalTrials.gov processed this record on February 10, 2009


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