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CompletedNCT03032224Updated Jul 28, 2020

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

An observational study in Cancer of Esophagus and Gastric Cancer, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by Vastra Gotaland Region · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
76
Sex
All
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Study 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.

02

Conditions studied

  • Cancer of Esophagus
  • Gastric Cancer

Keywords

  • Body composition
  • sarcopenia
  • Dysphagia
  • Surgery
  • Quality of Life
  • Morbidity
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 76 is below the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not fulfilling the above.
  • Patient declined participation.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
76 participants (actual)
Patient registry
No

Interventions

  • ProcedureResection of the esophagus and the gastroesophageal junction
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What researchers measure

Primary outcomes

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

    Body mass index (BMI) kg/m2

    Time frame: Three months

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

    Weight kg

    Time frame: Three months

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

    Fat free mass (FFM) kg;

    Time frame: Three months

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

    Fat mass (FM) kg;

    Time frame: Three months

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

    Lean tissue mass (LTM) kg;

    Time frame: Three months

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

    Total body water (TBW) l;

    Time frame: Three months

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

    Intra cellular water (ICW) l;

    Time frame: Three months

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

    Extra cellular water (ECW) l

    Time frame: Three months

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

07

Study locations

1 site
  • Surgical Department, Sahlgrenska University Hospital
    Gothenburg, Västra Götalandsregionen 41345, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03032224
Lead sponsor
Vastra Gotaland Region
Collaborators
Sahlgrenska University Hospital, The Göteborg Medical Society, Sweden
Responsible party
Sponsor
First posted
Jan 26, 2017
Start date
Mar 23, 2015
Primary completion
Jul 23, 2020
Completion
Jul 23, 2020
Last update
Jul 28, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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