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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032224
• Other study ID #: janpe4
• Status: Completed
• Start date: March 23, 2015
• Est. completion date: July 23, 2020

Study information

• Verified date: July 2020
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 23, 2020
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Esophagus
• Esophageal Neoplasms
• Gastric Cancer

Intervention

Procedure:
• Resection of the esophagus and the gastroesophageal junction

Locations

Country	Name	City	State
Sweden	Surgical Department, Sahlgrenska University Hospital	Gothenburg	Västra Götalandsregionen

Sponsors (3)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Sahlgrenska University Hospital, Sweden, The Göteborg Medical Society, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Body composition after surgery for esophageal cancer with curative intent.	Body mass index (BMI) kg/m2	Three months
Primary	Changes in Body composition after surgery for esophageal cancer with curative intent	Weight kg	Three months
Primary	Changes in Body composition after surgery for esophageal cancer with curative intent.	Fat free mass (FFM) kg;	Three months
Primary	Changes in Body composition after surgery for esophageal cancer with curative intent.	Fat mass (FM) kg;	Three months
Primary	Changes in Body composition after surgery for esophageal cancer with curative intent.	Lean tissue mass (LTM) kg;	Three months
Primary	Changes in Body composition after surgery for esophageal cancer with curative intent.	Total body water (TBW) l;	Three months
Primary	Changes in Body composition after surgery for esophageal cancer with curative intent.	Intra cellular water (ICW) l;	Three months
Primary	Changes in Body composition after surgery for esophageal cancer with curative intent.	Extra cellular water (ECW) l	Three months
Secondary	Changes in QoL (linear scale 0-100)		From surgery up to three months
Secondary	Changes in dysphagia (linear scale 0-100)		From surgery up to three months
Secondary	Length of stay (days)		From surgery up to three months
Secondary	Complications after surgery (Clavien-Dindo scale 0-5)		From surgery up to three months
Secondary	Mortality		Length of survival after surgery