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Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03061370
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Jessie A Elliott, 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.


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

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Study Type : Observational
Actual Enrollment : 317 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Esophagectomy or Gastrectomy
    Surgical resection


Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Esophageal or gastric cancer between 2010 and 2016
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.

Information from the National Library of Medicine

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


Locations
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Ireland
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
Sponsors and Collaborators
St. James's Hospital, Ireland
Investigators
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Principal Investigator: John V Reynolds, MCh FRCS Department of Surgery, St. James's Hospital, Dublin
Publications of Results:
Other Publications:
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Responsible Party: Dr Jessie A Elliott, Clinical Research Fellow, St. James's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT03061370    
Other Study ID Numbers: SJHDOS2016-01
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Sarcopenia
Obesity
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical