Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT03061370|
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : March 26, 2020
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.
|Condition or disease||Intervention/treatment|
|Esophageal Cancer Gastric Cancer Sarcopenia Sarcopenic Obesity Obesity Visceral Obesity Quality of Life Surgery Complication of Treatment Chemotherapeutic Toxicity Physical Activity Oncology||Procedure: Esophagectomy or Gastrectomy|
|Study Type :||Observational|
|Actual Enrollment :||317 participants|
|Official Title:||An Investigation of the Prevalence and Clinical Impact of Sarcopenia and Visceral Obesity Among Patients With Upper Gastrointestinal Malignancies|
|Actual Study Start Date :||January 1, 2010|
|Actual Primary Completion Date :||January 1, 2017|
|Actual Study Completion Date :||January 1, 2019|
- Procedure: Esophagectomy or Gastrectomy
- Neoadjuvant therapy toxicity [ Time Frame: 6 months ]
- Postoperative morbidity [ Time Frame: 6 months ]
- Oncologic outcome [ Time Frame: 6 months ]
- Survival [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061370
|Department of Surgery, St. James's Hospital|
|Dublin, Ireland, D4|
|Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital|
|Dublin, Ireland, D8|
|Principal Investigator:||John V Reynolds, MCh FRCS||Department of Surgery, St. James's Hospital, Dublin|