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

July 24, 2020 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Collaborators

Sahlgrenska University Hospital, Sweden
The Göteborg Medical Society, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2015

Primary Completion (Actual)

July 23, 2020

Study Completion (Actual)

July 23, 2020

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • janpe4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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