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Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients

18. juli 2012 opdateret af: M.D. Anderson Cancer Center

Feasibility Study of the Assessment of Symptom-Related Cytokines in Lung and GI Cancer Patients Undergoing Chemoradiation Therapy

Primary Objectives:

  • To determine the feasibility of a study that would describe changes of certain circulating inflammatory cytokines (interleukin-1, 6, 8, 10, 12, and tumor necrosis factor-alpha [TNF] and symptoms related to chemoradiation therapy (pre-therapy, during therapy and up to 3 months post-therapy) among patients with lung, esophageal, gastric, colorectal and anal cancer.
  • To determine the feasibility of studying neurocognitive function in patients with non-small cell lung cancer (NSCLC) at presentation and during chemoradiation therapy to determine the prevalence, severity, and pattern of cognitive symptoms.

Studieoversigt

Detaljeret beskrivelse

One of the ways to learn about the symptoms of chemoradiation therapy is by looking at how certain proteins called cytokines (found in the blood) change during therapy. Another way is to look at how thinking and memory may be changed because of treatment.

Before therapy starts, you will be asked to complete several questionnaires during a visit to the Radiation Oncology clinic at M. D. Anderson. These questionnaires measure physical and emotional symptoms. These questionnaires should take about 30 minutes to finish. Lung cancer patients will also complete some cognitive (mental) questionnaires. During this visit, the research nurse will teach you how to use the telephone system for measuring symptoms. You will tell the system the most convenient times for the telephone calls. The date of the call will be at the same or close to the date of your weekly clinic visit.

Before you begin your chemoradiation treatments, you will have a sample of blood drawn (around 2½ tablespoons). The sample of blood will be used to measure levels of cytokines in your blood pre treatment.

You will have about 2½ tablespoons of blood drawn again when you start chemoradiation, and then once a week while you are receiving treatment. These cytokines may be related to symptoms experienced while having treatment for cancer. These blood tests are being done to study the levels of cytokines in your blood during, and after treatment for cancer.

Symptoms will be monitored weekly using an interactive voice response telephone system. During chemoradiation, the automated telephone system will call you once a week to ask you to rate your symptoms and how much the symptoms interfere in your daily life. The information collected by these calls is only being used for this research study.

At the end of the chemoradiation, lung cancer patients will again be given questionnaires to measure cognitive symptoms.

For lung cancer patients who are post-chemotherapy, your symptoms will be monitored weekly for 3 months after therapy using the interactive voice response telephone system. For esophageal, gastric, colorectal, and anal patients who are post-therapy, your symptoms will be monitored weekly for 6 weeks after therapy using the interactive voice response telephone system. About 30 days after chemoradiation, you will have 2½ tablespoons of blood drawn at your regularly scheduled clinic visit. If you are not scheduled for a 3 month clinic visit, we will contact your local physician for blood lab results.

This is an investigational study. About 225 evaluable patients will take part in this study. All will be enrolled at M. D. Anderson.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

205

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • UT MD Anderson Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Study participants with lung, esophageal, gastric, colorectal or anal cancer.

Beskrivelse

Inclusion Criteria:

  1. Patients scheduled for chemoradiation therapy at MDACC.
  2. Adults > 18 years of age.
  3. Diagnosis of lung, esophageal, gastric, colorectal, or anal cancer.
  4. English-speaking.
  5. Lives in the United States.
  6. Adequate vision and hearing to use the IVR system.
  7. Provides written informed consent.

Exclusion Criteria:

  1. Patients with a current diagnosis of psychosis or dementia.
  2. Patients who are unable to complete the assessment measures or refuse to participate.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Symptom-Related Cytokines Questionnaire
Weekly questionnaires lasting about 30 minutes.
Andre navne:
  • Undersøgelse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Patient Symptom Assessment (Questionnaire)
Tidsramme: Weekly for 1-3 months post-therapy
Weekly for 1-3 months post-therapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2002

Primær færdiggørelse (Faktiske)

1. juli 2010

Studieafslutning (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

16. juli 2007

Først indsendt, der opfyldte QC-kriterier

16. juli 2007

Først opslået (Skøn)

17. juli 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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