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AzTrials

Cancer of EsophagusNCT03032224

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

An observational study of Cancer of Esophagus and Gastric Cancer, run by Vastra Gotaland Region at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cancer of Esophagus, Gastric Cancer
What is being tested?
Resection of the esophagus and the gastroesophageal junction
Type of treatment
Surgery or procedure
How many people
76 participants
Where
1 siteSweden
Study dates
23 Mar 2015to 23 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Not fulfilling the above.
  • Patient declined participation.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Surgical Department, Sahlgrenska University Hospital

    Gothenburg, Västra Götalandsregionen, 41345

Other trials in Sweden

About this study

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

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.

Being tested
Resection of the esophagus and the gastroesophageal junction
Keywords
Body composition, sarcopenia, Dysphagia, Surgery, Quality of Life, Morbidity
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Sarcopenia, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resection of the esophagus and the gastroesophageal junctionProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Body mass index (BMI) kg/m2

    Measured: Three months

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

    Weight kg

    Measured: Three months

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

    Fat free mass (FFM) kg;

    Measured: Three months

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

    Fat mass (FM) kg;

    Measured: Three months

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

    Lean tissue mass (LTM) kg;

    Measured: Three months

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

    Total body water (TBW) l;

    Measured: Three months

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

    Intra cellular water (ICW) l;

    Measured: Three months

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

    Extra cellular water (ECW) l

    Measured: Three months

Secondary outcomes (5)

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

    Measured: From surgery up to three months

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

    Measured: From surgery up to three months

  3. Length of stay (days)

    Measured: From surgery up to three months

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

    Measured: From surgery up to three months

  5. Mortality

    Measured: Length of survival after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study start23 Mar 2015
  3. Primary completion23 Jul 2020
  4. Study completion23 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03032224
Sponsor's protocol ID
janpe4
Status last verified
Jul 2020
First submitted
4 Jan 2017
Last updated
28 Jul 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer of Esophagus and Gastric Cancer, run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Body composition after surgery for esophageal cancer with curative intent. (time frame: Three months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03032224.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.

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