Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer

Completed

Conditions studied: Lung Cancer

In brief

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: 1. Polymorphisms in NER genes that modulate DNA repair capacity will also effect response to chemotherapy and to outcome. 2. Cytokine gene polymorphisms account for variations in symptom outcomes (specific symptoms and symptom clusters) before, during and after chemotherapy. 3. The COMT val/met polymorphism affects the metabolism of catecholamines on the modulation of response to sustained pain. 4. 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.

Key facts

Study ID

NCT00422500

Run by

M.D. Anderson Cancer Center

People needed

204

Starts

2003-11-01

Expected to finish

2010-12-01

Last updated by the study team

2012-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Jackson Memorial Hospital — Miami, Florida, United States
• Lyndon Baines Johnson General Hospital — Houston, Texas, United States
• Ben Taub General Hospital — Houston, Texas, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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