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CompletedNCT03061370Updated Mar 26, 2020

Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer

An observational study in Esophageal Cancer, Gastric Cancer and Sarcopenia, sponsored by St. James's Hospital, Ireland. Completed at 2 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.

Sponsored by St. James's Hospital, Ireland · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
317
Ages
18 Years and older
Sex
All
01

Study summary

In line with improvements in oncologic outcome for patients with esophageal cancer, the attritional impact of curative treatment with respect to functional status and health-related quality of life (HR-QL) in survivorship is increasingly an important focus. Functional recovery after surgery for esophageal cancer is commonly confounded by anorexia and early satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss. One in three disease-free patients has more than fifteen percent body weight loss at three years after esophagectomy.

The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men, while similar cut-off points have been validated in upper gastrointestinal and respiratory malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should also include determination of muscle function, for example gait speed or grip strength, where possible.

The presence of sarcopenia is associated with increase treatment-associated morbidity, impaired HR-QL, reduced physical and role functioning, and increased pain scores in older adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL over a six year period in older adults was accelerated in the presence of sarcopenia. As such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of HR-QL and functional status, and may reinforce a persistent illness identity, among patients following potentially curative treatment for esophageal cancer.

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Conditions studied

  • Esophageal Cancer
  • Gastric Cancer
  • Sarcopenia
  • Sarcopenic Obesity
  • Obesity
  • Visceral Obesity
  • Quality of Life
  • Surgery
  • Complication of Treatment
  • Chemotherapeutic Toxicity
  • Physical Activity
  • Oncology
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 317 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

St. James's Hospital, Ireland is the lead sponsor of 28 studies on the registry; 6 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Esophageal or gastric cancer between 2010 and 2016

Inclusion criteria

  • Initial staging computed tomography (CT) scan capturing the level of the L3 conducted at our Centre and available for review

Exclusion criteria

Exclusion Criteria:

  • Patients who had a history of previous gastrointestinal resection, other active malignancy, eating disorder, inflammatory bowel disease or other significant illness that might alter body composition were excluded from analysis.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
317 participants (actual)
Patient registry
No

Interventions

  • ProcedureEsophagectomy or Gastrectomy

    Surgical resection

06

What researchers measure

Primary outcomes

  1. Neoadjuvant therapy toxicity

    Time frame: 6 months

  2. Postoperative morbidity

    Time frame: 6 months

  3. Oncologic outcome

    Time frame: 6 months

  4. Survival

    Time frame: 5 years

07

Study locations

2 sites
  • Department of Surgery, St. James's Hospital
    Dublin, D4, Ireland
  • Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
    Dublin, D8, Ireland
08

References and documents

Publications

  • Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6. PubMed 18539529 ↗
  • Doyle SL, Bennett AM, Donohoe CL, Mongan AM, Howard JM, Lithander FE, Pidgeon GP, Reynolds JV, Lysaght J. Establishing computed tomography-defined visceral fat area thresholds for use in obesity-related cancer research. Nutr Res. 2013 Mar;33(3):171-9. doi: 10.1016/j.nutres.2012.12.007. Epub 2013 Jan 30. PubMed 23507222 ↗
  • Elliott JA, Doyle SL, Murphy CF, King S, Guinan EM, Beddy P, Ravi N, Reynolds JV. Sarcopenia: Prevalence, and Impact on Operative and Oncologic Outcomes in the Multimodal Management of Locally Advanced Esophageal Cancer. Ann Surg. 2017 Nov;266(5):822-830. doi: 10.1097/SLA.0000000000002398. PubMed 28796017 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 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
NCT03061370
Lead sponsor
St. James's Hospital, Ireland
Responsible party
Dr Jessie A Elliott (Clinical Research Fellow, St. James's Hospital, Ireland) — Principal investigator
First posted
Feb 23, 2017
Start date
Jan 1, 2010
Primary completion
Jan 1, 2017
Completion
Jan 1, 2019
Last update
Mar 26, 2020

Study contacts

John V Reynolds, MCh FRCS
principal investigator · Department of Surgery, St. James's Hospital, Dublin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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