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Study Summary
No. 2003-0701:.......Lung......Xin Shelley Wang......Symptom Research
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Study Summary Title
Study Summary
Number:
2003-0701
Study Title:Longitudinal Study of the Prevalence, Severity, and Interference of Multiple Symptoms in Advanced Lung Cancer
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Physician New Patient Referral
Name:Xin Shelley WangPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Symptom ResearchReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3470
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:N/A
Phase of Study:N/AReturn
Visit:
No special requirement for return visit. However, we will contact patients
every time the patient comes for clinical evaluation.
Treatment
Agents:
NoneHome Care:No plan for home care; symptom assessment made using patient's home phone.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
Observation of symptoms: about 18 weeks
Description/
Intervention:
The goal of this research study is to learn about chemotherapy symptoms in
patients with lung cancer. This study will also test the usefulness of a
special telephone system for measuring the symptoms of patients during and
following therapy.
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Study Objectives / Outcomes
1. 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.

2. 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.

3. To compare symptom severity, adequacy of symptom management, and interference with affective status and health-related function by patient's minority status.

4. To explore the serum level of inflammatory cytokines during chemotherapy among lung cancer patients.

5. 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.

6. 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.
7. To evaluate neurocognitive function to determine the prevalence, severity, and pattern of cognitive symptoms.
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Study Status Information
Study Activation / Registration Date:11/12/2003
IRB Review and Approval Date:11/12/2003
Study Type:
Recruitment Status:Terminated
Projected Accrual:224
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Is an adult > 18 years of age

2) Is diagnosed with Stage III or IV Lung cancer

3) Is scheduled for a new chemotherapy regimen. Patients who have received prior chemotherapy are eligible.

4) Is English- or Spanish-speaking

5) Currenlty lives in the United States

Exclusion Criteria:1) Does not have access to telephones

2) Is unable to use the telephone interactive system

3) Has a current diagnosis of psychosis or dementia

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Links
Registration Number: NCT00422500
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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