Clinical trial NCT03061370: Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer
Official title: An Investigation of the Prevalence and Clinical Impact of Sarcopenia and Visceral Obesity Among Patients With Upper Gastrointestinal Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Gastric Cancer
Sarcopenia
Sarcopenic Obesity
Obesity
Visceral Obesity
Quality of Life
Surgery
Complication of Treatment
Chemotherapeutic Toxicity
Physical Activity
Oncology
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Esophageal or gastric cancer between 2010 and 2016

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.


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.

Primary outcomes:
measure: Neoadjuvant therapy toxicity
timeFrame: 6 months
measure: Postoperative morbidity
timeFrame: 6 months
measure: Oncologic outcome
timeFrame: 6 months
measure: Survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Department of Surgery, St. James's Hospital
city: Dublin
country: Ireland
facility: Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Study officials:
affiliation: Department of Surgery, St. James's Hospital, Dublin
name: John V Reynolds, MCh FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.