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

Completed

• Conditions: Gastric Cancer; Cancer of Esophagus

• Registration Number: NCT03032224
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-23
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Status Verified: 2020-07
• Primary Completion: 2020-07-23
• Study Completion: 2020-07-23
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Body composition after surgery for esophageal cancer with curative intent	Three months	Weight kg
Changes in Body composition after surgery for esophageal cancer with curative intent.	Three months	Extra cellular water (ECW) l

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Surgical Department, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götalandsregionen, Sweden