Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer

Completed

• Conditions: Oncology; Sarcopenic Obesity; Obesity; Visceral Obesity; Gastric Cancer; Surgery; Esophageal Cancer; Sarcopenia; Quality of Life; Complication of Treatment

• Registration Number: NCT03061370
• Lead Sponsor: St. James's Hospital, Ireland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2017-01-01
• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Study Completion: 2019-01-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neoadjuvant therapy toxicity	6 months
Oncologic outcome	6 months
Postoperative morbidity	6 months
Survival	5 years

Trial Locations

Locations (2)

Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital; 🇮🇪 Dublin, Ireland

Department of Surgery, St. James's Hospital; 🇮🇪 Dublin, Ireland