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.

BACKGROUND

Pre-operative very low calorie diets (VLCDs) can achieve rapid and safe weight loss, yet no studies have evaluated VLCDs in the severely obese endometrial cancer population prior to surgery. Our aim was to evaluate the safety and feasibility of a 4-6 week pre-operative nutritional intervention with the Optifast VLCD prior to surgery in patients with clinical stage 1, Grade 1 endometrioid endometrial adenocarcinoma and a body mass index ≥ 35 kg/m2.

METHODS

This was an investigator-initiated single-arm prospective observational study. Co-primary endpoints were safety and feasibility. Secondary endpoints were changes in anthropometric measures, blood pressure, biochemistry, perioperative complications, length of stay and final tumour stage. Tolerability and compliance of the VLCD were assessed by fortnightly questionnaires and urinary ketones.

RESULTS

Twenty-eight patients were enrolled, of which 25 underwent the intervention. 22/25 patients (88%) completed at least 4 weeks of Optifast. Mean (SD) age was 56.4 (6.3) years, and mean body mass index (BMI) was 45.2 (7.1) kg/m2. Significant decreases in weight (mean 8.2 kg [3.6]), BMI (mean 3.1 kg/m2 [1.3]), waist and hip circumference (mean 5.7 [6.5] and 4.5 cm [4.1], respectively), and diastolic blood pressure (10 mmHg [14.1]) were observed (p < 0.001 for all). One patient had a flare of gout. All patients had laparoscopic surgery without adverse events. Optifast was considered acceptable, and compliance was 40% to 61.9%. Eighty-eight percent (22/25) of patients had FIGO 2009 Stage 1A Grade 1 endometrioid endometrial adenocarcinoma on final staging.

CONCLUSIONS

A 4-6 week pre-operative VLCD in severely obese clinically low-risk endometrial cancer patients appears safe, feasible and well tolerated.