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NCT00422500 · ClinicalTrials.gov registry record
Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 204
- Enrollment target
NCT00422500: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT00422500 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 204 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00422500 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 204 participants
- Enrollment target
Study Summary
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.
Primary Outcome
IVR telephone system to collect longitudinal data on symptom patterns and severity using patient tumor response evaluation after 2-3 cycles chemotherapy and total weekly IVR assessment period at 18 weeks.
Interventions
- BEHAVIORAL Questionnaire
- OTHER Blood Samples
- BEHAVIORAL Telephone Interactive System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2003-11 |
| Est. Completion | 2010-12 |
What the finished NCT00422500 record still lists
NCT00422500 is an observational study that tracks outcomes without assigning an intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Questionnaire is the first listed.
NCT00422500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00422500 about?
NCT00422500 is a clinical study titled "Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer". 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 ...
What is the current status of trial NCT00422500?
This trial is currently completed. The enrollment target is 204 participants. The study started on 2003-11. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00422500?
The interventions under investigation include: Questionnaire (BEHAVIORAL), Blood Samples (OTHER), Telephone Interactive System (BEHAVIORAL).
Who is sponsoring clinical trial NCT00422500?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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