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Clinical Trials/NCT03061370
NCT03061370
Completed
Not Applicable

An Investigation of the Prevalence and Clinical Impact of Sarcopenia and Visceral Obesity Among Patients With Upper Gastrointestinal Malignancies

St. James's Hospital, Ireland2 sites in 1 country317 target enrollmentJanuary 1, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
St. James's Hospital, Ireland
Enrollment
317
Locations
2
Primary Endpoint
Oncologic outcome
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2010
End Date
January 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. James's Hospital, Ireland
Responsible Party
Principal Investigator
Principal Investigator

Dr Jessie A Elliott

Clinical Research Fellow

St. James's Hospital, Ireland

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Oncologic outcome

Time Frame: 6 months

Neoadjuvant therapy toxicity

Time Frame: 6 months

Postoperative morbidity

Time Frame: 6 months

Survival

Time Frame: 5 years

Study Sites (2)

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