- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03032224
Analysis of Body Composition in Relation to Outcome After Surgery in a Cohort of Patients With Esophageal Cancer
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
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Västra Götalandsregionen
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Gothenburg, Västra Götalandsregionen, Sverige, 41345
- Surgical Department, Sahlgrenska University Hospital
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
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
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- janpe4
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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