Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer

NCT ID: NCT03061370

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2019-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Esophagectomy or Gastrectomy

Surgical resection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. James's Hospital, Ireland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Jessie A Elliott

Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John V Reynolds, MCh FRCS

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, St. James's Hospital, Dublin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Surgery, St. James's Hospital

Dublin, , Ireland

Site Status

Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital

Dublin, , Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18539529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23507222 (View on PubMed)

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.

Reference Type RESULT
PMID: 28796017 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SJHDOS2016-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.