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

NCT03032224 | Completed DMC

• 1 other identifier: janpe4
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Esophagus; Gastric Cancer

Keywords

Body composition; sarcopenia; Dysphagia; Surgery; Quality of Life; Morbidity

Outcome Measures

Primary Outcomes (8)

• Changes in Body composition after surgery for esophageal cancer with curative intent.

  Body mass index (BMI) kg/m2

  Three months

• Changes in Body composition after surgery for esophageal cancer with curative intent

  Weight kg

  Three months

• Changes in Body composition after surgery for esophageal cancer with curative intent.

  Fat free mass (FFM) kg;

  Three months

• Changes in Body composition after surgery for esophageal cancer with curative intent.

  Fat mass (FM) kg;

  Three months

• Changes in Body composition after surgery for esophageal cancer with curative intent.

  Lean tissue mass (LTM) kg;

  Three months

• Changes in Body composition after surgery for esophageal cancer with curative intent.

  Total body water (TBW) l;

  Three months

• Changes in Body composition after surgery for esophageal cancer with curative intent.

  Intra cellular water (ICW) l;

  Three months

• Changes in Body composition after surgery for esophageal cancer with curative intent.

  Extra cellular water (ECW) l

  Three months

Secondary Outcomes (5)

• Changes in QoL (linear scale 0-100)

  From surgery up to three months

• Changes in dysphagia (linear scale 0-100)

  From surgery up to three months

• Length of stay (days)

  From surgery up to three months

• Complications after surgery (Clavien-Dindo scale 0-5)

  From surgery up to three months

• Mortality

  Length of survival after surgery

Interventions

Resection of the esophagus and the gastroesophageal junction PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not fulfilling the above.
• Patient declined participation.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Sahlgrenska University Hospital: collaborator
• The Göteborg Medical Society, Sweden: collaborator

Study Sites (1)

Surgical Department, Sahlgrenska University Hospital

Gothenburg, Västra Götalandsregionen, 41345, Sweden

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Sarcopenia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 26, 2017
• Study Start: March 23, 2015
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)