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Analysis of Body Composition in Relation to Outcome After Surgery in a Cohort of Patients With Esophageal Cancer

24. juli 2020 opdateret af: Vastra Gotaland Region

Analysis of Sarcopenia and Body Composition in Relation to Outcome in a Cohort of Patients With Esophageal Cancer or Cancer of the Gastroesophageal Junction Before and After Surgery With Curative Intent

The occurrence of dysphagia is a well-known early feature of esophageal cancer that may reduce caloric intake and thus cause weight loss. Sarcopenia is considered to be a consequence of such involuntary nutritional restriction. The prevalence of sarcopenia in patients with esophageal cancer before and after surgery is not well known and its possible consequences have been debated.

Aim: The aim of this study was to prospectively explore body composition and function in a cohort of patients with esophageal cancer before and after surgery with curative intent. In particular, to investigate the prevalence and development of sarcopenia and body composition as a consequence to surgery for esophageal cancer and the possible relation to morbidity, length of stay and quality of life (QoL).

Methods: In a cohort of 76 patients who had esophageal- or cardia-cancer and were planned for surgery with a curative intent, data on body-composition measured with bioimpedance, working capacity (cardiac stress test), grip strength and QoL (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 version 3.0) were prospectively collected. Data regarding dysphagia was derived from an esophagus related quality of life form (EORTC QLQ-OES18). Data on tumour stage and type, complications, length of stay and preoperative weight loss were collected from medical charts.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

76

Kontakter og lokationer

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

Studiesteder

    • Västra Götalandsregionen
      • Gothenburg, Västra Götalandsregionen, Sverige, 41345
        • Surgical Department, Sahlgrenska University Hospital

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The study was a prospective collected cohort study in 76 patients who were referred to the surgery clinic at the Sahlgrenska University hospital 2005-2010. Patients with esophageal cancer or cancer of the gastroesophageal junction (Siewert I or II), who were scheduled to undergo resection surgery with curative intent, were asked to participate. Patients were excluded if they were found to have an advanced tumour stage or if they declined participation.

Beskrivelse

Inclusion Criteria:

  • Cancer of the gastro-esophageal junction or the esophagus.
  • Planned for curative surgery.
  • Informed consent

Exclusion Criteria:

  • Not fulfilling the above.
  • Patient declined participation.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Body composition after surgery for esophageal cancer with curative intent.
Tidsramme: Three months
Body mass index (BMI) kg/m2
Three months
Changes in Body composition after surgery for esophageal cancer with curative intent
Tidsramme: Three months
Weight kg
Three months
Changes in Body composition after surgery for esophageal cancer with curative intent.
Tidsramme: Three months
Fat free mass (FFM) kg;
Three months
Changes in Body composition after surgery for esophageal cancer with curative intent.
Tidsramme: Three months
Fat mass (FM) kg;
Three months
Changes in Body composition after surgery for esophageal cancer with curative intent.
Tidsramme: Three months
Lean tissue mass (LTM) kg;
Three months
Changes in Body composition after surgery for esophageal cancer with curative intent.
Tidsramme: Three months
Total body water (TBW) l;
Three months
Changes in Body composition after surgery for esophageal cancer with curative intent.
Tidsramme: Three months
Intra cellular water (ICW) l;
Three months
Changes in Body composition after surgery for esophageal cancer with curative intent.
Tidsramme: Three months
Extra cellular water (ECW) l
Three months

Sekundære resultatmål

Resultatmål
Tidsramme
Changes in QoL (linear scale 0-100)
Tidsramme: From surgery up to three months
From surgery up to three months
Changes in dysphagia (linear scale 0-100)
Tidsramme: From surgery up to three months
From surgery up to three months
Length of stay (days)
Tidsramme: From surgery up to three months
From surgery up to three months
Complications after surgery (Clavien-Dindo scale 0-5)
Tidsramme: From surgery up to three months
From surgery up to three months
Mortality
Tidsramme: Length of survival after surgery
Length of survival after surgery

Samarbejdspartnere og efterforskere

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

Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

23. marts 2015

Primær færdiggørelse (Faktiske)

23. juli 2020

Studieafslutning (Faktiske)

23. juli 2020

Datoer for studieregistrering

Først indsendt

4. januar 2017

Først indsendt, der opfyldte QC-kriterier

23. januar 2017

Først opslået (Skøn)

26. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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