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Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer

NCT00422500 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 204

Last updated 2012-08-02

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Questionnaire

Surveys about symptoms, mood, and quality of life.

BEHAVIORAL

Telephone Interactive System

Automated telephone system call once a week during therapy, rating of severity of symptoms and daily life interference done with numeric key pad. Post therapy is complete, a 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Xin Shelley Wang, MD · M.D. Anderson Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00422500 on ClinicalTrials.gov