Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032224
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : July 28, 2020
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
The Göteborg Medical Society, Sweden
Information provided by (Responsible Party):
Vastra Gotaland Region

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.


Condition or disease Intervention/treatment
Cancer of Esophagus Gastric Cancer Procedure: Resection of the esophagus and the gastroesophageal junction

Layout table for study information
Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 23, 2015
Actual Primary Completion Date : July 23, 2020
Actual Study Completion Date : July 23, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032224


Locations
Layout table for location information
Sweden
Surgical Department, Sahlgrenska University Hospital
Gothenburg, Västra Götalandsregionen, Sweden, 41345
Sponsors and Collaborators
Vastra Gotaland Region
Sahlgrenska University Hospital, Sweden
The Göteborg Medical Society, Sweden
Layout table for additonal information
Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03032224    
Other Study ID Numbers: janpe4
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vastra Gotaland Region:
Body composition
sarcopenia
Dysphagia
Surgery
Quality of Life
Morbidity
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Diseases