Clinical trial NCT03032224: Analysis of Body Composition in Relation to Outcome After Surgery in a Cohort of Patients With Esophageal Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Esophagus
Gastric Cancer
Keywords: Body composition
sarcopenia
Dysphagia
Surgery
Quality of Life
Morbidity
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Sahlgrenska University Hospital
name: The Göteborg Medical Society, Sweden
First posted: 2017-01-26
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
timeFrame: Three months
measure: Changes in Body composition after surgery for esophageal cancer with curative intent
timeFrame: Three months
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
timeFrame: Three months
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
timeFrame: Three months
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
timeFrame: Three months
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
timeFrame: Three months
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
timeFrame: Three months
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
timeFrame: Three months
Secondary outcomes:
measure: Changes in QoL (linear scale 0-100)
timeFrame: From surgery up to three months
measure: Changes in dysphagia (linear scale 0-100)
timeFrame: From surgery up to three months
measure: Length of stay (days)
timeFrame: From surgery up to three months
measure: Complications after surgery (Clavien-Dindo scale 0-5)
timeFrame: From surgery up to three months
measure: Mortality
timeFrame: Length of survival after surgery
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Surgical Department, Sahlgrenska University Hospital
state: Västra Götalandsregionen
Study officials:
References: