Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001472763
Ethics application status
Approved
Date submitted
7/11/2022
Date registered
22/11/2022
Date last updated
22/11/2022
Date data sharing statement initially provided
22/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Defining and characterising malnutrition and sarcopenia in patients undergoing oesophageal and gastric cancer surgery: a pilot observational study.
Scientific title
Defining and characterising malnutrition and sarcopenia, and the relationship with clinical and patient outcomes, throughout the treatment pathway for oesophagogastric cancer surgery: a pilot observational study.
Secondary ID [1] 308250 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal cancer 328028 0
Gastric cancer 328029 0
Malnutrition 328030 0
Sarcopenia 328031 0
Oesophagectomy surgery 328032 0
Gastrectomy surgery 328033 0
Condition category
Condition code
Cancer 325089 325089 0 0
Oesophageal (gullet)
Cancer 325090 325090 0 0
Stomach
Surgery 325091 325091 0 0
Other surgery
Diet and Nutrition 325249 325249 0 0
Other diet and nutrition disorders
Musculoskeletal 325250 325250 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Condition observed
1. Malnutrition: baseline (before surgery) and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively. Assessment of malnutrition includes measuring body weight, body mass index (BMI), weight loss, muscle mass and dietary intake (3-day food diary). Muscle mass will be assessed using computed tomography (CT) when the images are taken at 3 time points for routine clinical purposes (initial diagnosis, preoperative restaging, and 12-month surveillance). Bioelectrical impedance spectroscopy (BIS) will also be used to measure muscle mass before surgery, and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery.
2. Sarcopenia: baseline (before surgery) and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively. Sarcopenia diagnosis includes assessment of muscle strength (hand-grip strength dynamometer), muscle mass (CT or BIS body composition assessment), muscle quality or density (CT body composition assessment), and physical function (6-meter walk test).
3. Quality of life (QOL): baseline (before surgery) and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively. Assessed using the European Organisation for Research Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30, version 3) and the oesophagogastric cancer specific module (EORTC QLQ-OG25).

Additional information regarding the assessment of the above-mentioned conditions:
1. CT body composition analysis. The CT image used to assess body composition is those taken for routine clinical purposes at initial diagnosis, for restaging after chemotherapy and/or radiotherapy (this time point is before surgery) and at 12 months after surgery. This will take approximately 30-40 minutes to analyze the scan and obtain the results. Assessment of the CT image is done outside of the participant contact time. The CT body composition assessment is completed by a trained and competent dietitian, with supervision and assistance from a radiologist as required. A second trained dietitian will assess 10% of the CT images to determine inter-rater reliability.
2. Sarcopenia diagnosis. The three measurements required to diagnose sarcopenia are muscle mass (fat-free mass index using bioimpedance spectroscopy (BIS)), muscle strength (using hand-grip strength dynamometer), and physical function (using a 6-meter timed walk test). At each time point, these assessments will be carried out by a dietitian who is trained to operate and interpret the results from the BIS machine (no supervision is required). The assessments will take place in the surgical outpatient clinic rooms at Alfred Hospital. We anticipate that it may take up to 30 minutes to complete these assessments.
3. Questionnaires. The QOL surveys and 3-day food diaries are intended to be completed by the participant prior to their study appointment. On the occasion where the survey has not been completed, we estimate that it may take 15-20 minutes for the dietitian to complete them with the patient. Supervision is not required. Completion of the questionnaires will take place in the surgical outpatient clinic at The Alfred Hospital.

Exposure
Potentially curative surgical resection of oesophageal, gastric, or oesophagogastric junction cancer.
Intervention code [1] 324710 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332908 0
Assessment of skeletal muscle index (SMI, cm2/m2) and skeletal muscle density (muscle quality), as a composite measure, using computed tomography (CT) image body composition analysis.
Timepoint [1] 332908 0
Baseline (diagnosis), preoperatively (re-staging), 12 months postoperatively.
Primary outcome [2] 333101 0
Sarcopenia diagnosis as defined by the European Working Group on Sarcopenia in Older People (EWGSOP) consensus, using the CT body composition results for the muscle assessment component.
Timepoint [2] 333101 0
Baseline (diagnosis), preoperatively (re-staging), 12 months postoperatively.
Secondary outcome [1] 415078 0
Assessment of muscle mass, as fat-free mass index (FFMI, kg/m2), using bioimpedance spectroscopy (BIS) body composition analysis.
Timepoint [1] 415078 0
Preoperatively, and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively.
Secondary outcome [2] 415803 0
Sarcopenia diagnosis as defined by the European Working Group on Sarcopenia in Older People (EWGSOP) consensus, using the BIS body composition results for the muscle assessment component.
Timepoint [2] 415803 0
Preoperatively, and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively.
Secondary outcome [3] 415804 0
Malnutrition diagnosis is defined by the Global Leadership Initiative on Malnutrition (GLIM) criteria, the International Classification of Diseases, edition 10 (ICD-10) and the European Society of Enteral and Parenteral Nutrition (ESPEN) definition. The criteria used to diagnose malnutrition using each of the definitions, and subsequent malnutrition diagnosis will be collected prospectively at each study assessment at the pre-determined time points.
Timepoint [3] 415804 0
Preoperatively, and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively.
Secondary outcome [4] 415805 0
Body weight (measured in kg using calibrated digital scales), height (measured in metres, using height stadiometer), body mass index (BMI, kg/m2), and percentage weight loss (as a composite measure).
Timepoint [4] 415805 0
Preoperatively, and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively.
Secondary outcome [5] 415806 0
Dietary intake, including food, fluids, oral nutrition support, and enteral nutrition, was measured using a patient-recorded 3-day food diary.
Timepoint [5] 415806 0
Preoperatively, and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively.
Secondary outcome [6] 415807 0
Muscle strength, using a hand-grip dynamometer, in accordance with the EWGSOP definition of sarcopenia.
Timepoint [6] 415807 0
Preoperatively, and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively.
Secondary outcome [7] 415808 0
Physical function, using a 6-meter timed walk test, according to the EWGSOP definition of sarcopenia.
Timepoint [7] 415808 0
Preoperatively, and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively.
Secondary outcome [8] 415809 0
Quality of life is measured as a composite outcome using the European Organisation for Research Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30, version 3) and the module specific to oesophagogastric cancer (EORTC QLQ-OG25).
Timepoint [8] 415809 0
Preoperatively, and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postoperatively.
Secondary outcome [9] 415810 0
Postoperative complications according to the Clavien-Dindo Classification of Surgical Complications criteria.
Timepoint [9] 415810 0
Postoperatively, within hospital admission.
Secondary outcome [10] 415811 0
Length of postoperative hospital stay, measured from the date of surgery to the date of acute hospital discharge. Length of stay data will be measured prospectively and taken at the point of hospital discharge and verified using hospital records.
Timepoint [10] 415811 0
Measured at point of discharge from the acute hospital setting.

Eligibility
Key inclusion criteria
Adults greater than or equal to 18 years of age.
Diagnosis of an oesophageal, oesophagogastric junction, or gastric carcinoma.
Eligible for oesophagectomy, total gastrectomy or total extended gastrectomy, partial gastrectomy, or distal gastrectomy with curative intent.
Must be a patient of the Alfred Health Upper Gastrointestinal Surgery unit with multimodal treatment options discussed at The Alfred UGIS oncology multidisciplinary meeting.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients less than 18 years of age
• Resection of the oesophagus or stomach for reasons other than carcinoma resection
• Planned for a palliative surgical procedure
Resection of benign cancers, e.g. gastrointestinal stromal tumours (GIST)
Ineligible to undergo BIS assessment due to BMI greater than or equal to 35kg/m2, patients with clinical signs of oedema, patients with endocrine diseases that influence body composition (e.g. Cushing syndrome), patients who have a pacemaker or an electronic implantable device, or patients treated with growth hormone. NOTE: these patients will only be excluded from the BIS component of the study, their CT images can still be obtained to assess body composition.
Patients who do not wish to have their medical follow-up at The Alfred Hospital and who are not willing to come to the Alfred for research purposes only
Patients who are unable to comply with the requirements of the study due to cognitive impairment

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
According to relevant studies, approximately 50% of OGC patients are sarcopenic (low muscularity) prior to surgery. Based on the capacity to differentiate a minimum of two distinct groups of patients (sarcopenia and non-sarcopenic) using measures of muscularity the assumption was made that the mean difference in skeletal muscle index (measured by CT) was 10.5cm2/m2 (± 11.9). Given a significance level of p <0.05 and a statistical power (1-ß) of 80% the minimum sample size required to detect the above-mentioned difference in muscularity between groups is 34 participants. To account for a recruitment rate of 85% and allow for a 20% dropout rate or complications preventing repeat measures or mortality, a recruitment target of 46 participants would be required.
Statistical analysis will be undertaken using SPSS Statistics Version 23 (IBM Corp., New York, USA). Parametric and non-parametric tests will be used for normalised and non-normalised variables, respectively. A repeated measures ANOVA analysis will be used to assess changes over time within groups of sarcopenia and non-sarcopenic participants. Correlation (Pearson’s or Spearman coefficient) analysis will be used to explore the relationship between sarcopenia diagnosis, physical function, muscularity and other variables. Regression analysis will be used to assess the impact of sarcopenia on functional recovery adjusting for known or probable predictors using a stepwise variable selection procedure. Hypothesis tests will be considered significant if p <0.05. If encountered, multiple testing will be controlled for (a Bonferroni correction will be applied).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/07/2018
Date of last participant enrolment
Anticipated
Actual
14/09/2021
Date of last data collection
Anticipated
Actual
13/09/2022
Sample size
Target
46
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23437 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 38839 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312506 0
Hospital
Name [1] 312506 0
Alfred Health
Country [1] 312506 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
The Alfred Hospital
55 Commercial Rd, Melbourne, VIC, 3004.
Country
Australia
Secondary sponsor category [1] 314094 0
None
Name [1] 314094 0
Address [1] 314094 0
Country [1] 314094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311842 0
The Alfred Hospital
Ethics committee address [1] 311842 0
Ethics committee country [1] 311842 0
Australia
Date submitted for ethics approval [1] 311842 0
22/03/2018
Approval date [1] 311842 0
17/04/2018
Ethics approval number [1] 311842 0
104/18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122562 0
Ms Lisa Murnane
Address 122562 0
The Alfred Hospital, Nutrition Department
55 Commercial Rd, Melbourne, VIC, 3004.
Country 122562 0
Australia
Phone 122562 0
+61 487180858
Fax 122562 0
Email 122562 0
[email protected]
Contact person for public queries
Name 122563 0
Lisa Murnane
Address 122563 0
The Alfred Hospital, Nutrition Department
55 Commercial Rd, Melbourne, VIC, 3004.
Country 122563 0
Australia
Phone 122563 0
+61 487180858
Fax 122563 0
Email 122563 0
[email protected]
Contact person for scientific queries
Name 122564 0
Lisa Murnane
Address 122564 0
The Alfred Hospital, Nutrition Department
55 Commercial Rd, Melbourne, VIC, 3004.
Country 122564 0
Australia
Phone 122564 0
+61 487180858
Fax 122564 0
Email 122564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be shared in the form of one/several peer-reviewed publications. It was specified in the ethics application that all reported data will be pooled, not available as individual patient data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.