A single arm pilot observational study to evaluate the safety and feasibility of a pre-operative very low calorie diet in severely obese patients with endometrial cancer

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Abstract

Introduction/Background Pre-operative Very Low Calorie Diets (VLCDs) can achieve rapid and safe weight loss in patients, yet no studies have evaluated VLCDs in the severely obese endometrial cancer population prior to surgery. Our objective was to evaluate the safety and feasibility of a 4–6-week pre-operative nutritional intervention with the VLCD Optifast™ prior to definitive surgery in patients with clinical stage 1, Grade 1 endometrioid endometrial adenocarcinoma and a body mass index (BMI) ≥ 35kg/m2.

Methodology This was an investigator-initiated single arm prospective observational study. Eligible participants were enrolled at two academic tertiary gynaecologic oncology centres. Co-primary endpoints were safety and feasibility. Secondary endpoints were body weight, hip and waist circumference, hip/waist ratio, blood pressure, full blood count, serum electrolytes, liver enzymes, albumin, and lipid profile, blood glucose, insulin, and HbA1c, estimated blood loss, perioperative complications, length of hospital stay, final tumour stage, grade and histotype. Tolerability of the VLCD was assessed by the Very Low-Calorie Questionnaire at weeks 2, 4 and 6.

Results 25 patients were enrolled in the study. Mean (SD) age was 56.4 (6.3) years and mean BMI was 45.2 (7.1) kg/m2. Significant decreases in weight (mean 8.2kg [3.6]), BMI (mean 3.1kg/m2 [1.3]), waist and hip circumference (mean 5.7cm [6.5] and 4.5cm [4.1] respectively), and diastolic blood pressure (10mmHg [14.1]) were observed (P <0.001 for all). All participants had definitive laparoscopic surgery without adverse events. Optifast™ was considered acceptable and compliance was high. All patients had low risk (stage 1A) or low intermediate risk (IB/II) endometrial cancers on final staging.

Conclusion A 4–6-week pre-operative VLCD in severely obese patients with low grade, clinically early-stage endometrioid endometrial cancer appears safe and feasible. Significant reductions in weight, BMI, waist and hip circumference, diastolic blood pressure, HbA1C, and total cholesterol were observed. Optifast™ was well tolerated.
Original languageEnglish
JournalInternational Journal of Gynecological Cancer
Volume34
Issue numberA150-A151
Publication statusE-pub ahead of print - 2024

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