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Maladaptive Adipose Tissue Activity in Cancer

23. marts 2022 opdateret af: Virginia Commonwealth University
The purpose of this pilot research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer. Many patients affected by cancer lose weight, despite normal or increased nutrition. It may progress to the condition called "cancer-associated cachexia." Cancer associated cachexia is defined by an ongoing loss of skeletal muscle mass with or without the loss of fat mass, and may negatively affect quality of life and the ability to undergo cancer treatments. Metabolism is the breakdown of food by the body into the energy that your body needs.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298-0070
        • Virginia Commonwealth University/ Massey 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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients equal to or greater than forty years of age with an active cancer diagnosis.

Beskrivelse

Inclusion Criteria:

  • ≥ 40 years of age
  • Have active cancer diagnosis.
  • Have had a PET/CT scan within the past 12 months at time of enrollment.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Current use of beta-blockers
  • Women who are pregnant or unsure of their pregnancy status
  • Women who are breastfeeding
  • Suffers from severe claustrophobia
  • Diagnosed with a serious psychiatric condition which could impede the judgement of the investigators, and/or the successful conduct of the recording.
  • In remission stage for cancer diagnosis

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Brown Adipose Tissue Positive patients
Patients with known malignancy and incidental finding of positron emission tomography/ computerized tomography (PET/CT) scans positive for brown adipose tissue (BAT). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.
Procedure: Resting Energy Expenditure
During each visit, the participant will be assessed in a resting state in a stable temperature controlled environment, and will undergo tests to find out how the body adjusts its metabolism to different temperatures.
Andre navne:
  • ENRGEXP
Andet: Thermal Comfort Questionnaire
Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.
Brown Adipose Tissue Negative Patients
Patients with known malignancy and no evidence of brown adipose tissue BAT activity positron emission tomography/ computerized tomography (PET/CT) scans to be matched to group 1 for primary tumor and stage, sex, age (±5 years), BMI (±3 Kg/m2). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.
Procedure: Resting Energy Expenditure
During each visit, the participant will be assessed in a resting state in a stable temperature controlled environment, and will undergo tests to find out how the body adjusts its metabolism to different temperatures.
Andre navne:
  • ENRGEXP
Andet: Thermal Comfort Questionnaire
Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer.
Tidsramme: 27 Months
Characterization of the energy metabolism profiles of cancer patients with and without evidence of BAT activation will be assessed utilizing one sided t-test.
27 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in energy expenditure between room temperature and response to warm exposure (energy expenditure) in BAT-positive and BAT-negative cancer patients.
Tidsramme: 27 Months
Assessment of environmental modulation as an effective strategy to mitigate maladaptive BAT activation in patients with malignancy will be assessed by two-sided t-test.
27 Months

Samarbejdspartnere og efterforskere

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

Sponsor

Virginia Commonwealth University

Samarbejdspartnere

National Cancer Institute (NCI)

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 (Faktiske)

16. august 2018

Primær færdiggørelse (Faktiske)

20. maj 2020

Studieafslutning (Faktiske)

20. maj 2020

Datoer for studieregistrering

Først indsendt

1. august 2018

Først indsendt, der opfyldte QC-kriterier

6. august 2018

Først opslået (Faktiske)

8. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MCC-17-13470
  • P30CA016059 (U.S. NIH-bevilling/kontrakt)
  • NCI-2018-01510 (Anden identifikator: NCI CTRP)
  • HM20009089 (Anden identifikator: IRB No.)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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 .

Kliniske forsøg med Kræft nr

Kliniske forsøg med Resting Energy Expenditure

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Placeringer

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