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NCT Number: NCT03032224

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

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.

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Key information

Conditions

Cancer of Esophagus Atrophy Deglutition Disorders Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Sarcopenia Signs and Symptoms Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical Department, Sahlgrenska University Hospital

Gothenburg, Västra Götalandsregionen, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resection of the esophagus and the gastroesophageal junction

Procedure

Primary outcomes

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

    Time frame: Three months

    Body mass index (BMI) kg/m2

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

    Time frame: Three months

    Weight kg

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

    Time frame: Three months

    Fat free mass (FFM) kg;

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

    Time frame: Three months

    Fat mass (FM) kg;

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

    Time frame: Three months

    Lean tissue mass (LTM) kg;

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

    Time frame: Three months

    Total body water (TBW) l;

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

    Time frame: Three months

    Intra cellular water (ICW) l;

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

    Time frame: Three months

    Extra cellular water (ECW) l

Secondary outcomes

  1. Changes in QoL (linear scale 0-100)

    Time frame: From surgery up to three months

  2. Changes in dysphagia (linear scale 0-100)

    Time frame: From surgery up to three months

  3. Length of stay (days)

    Time frame: From surgery up to three months

  4. Complications after surgery (Clavien-Dindo scale 0-5)

    Time frame: From surgery up to three months

  5. Mortality

    Time frame: Length of survival after surgery

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Sahlgrenska University Hospital
  • The Göteborg Medical Society, Sweden

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2017
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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