Intentional weight loss before endometrial cancer surgery to support postoperative recovery (ENDO-CARE): a multicentre, feasibility randomised controlled trial in England

Background Obesity increases the complication risk after endometrial cancer surgery. We assessed the feasibility of a preoperative weight loss intervention for women with endometrial cancer and excess weight. Methods In this feasibility randomised trial at nine centres across England, women with a BMI of 28 kg/m 2 and higher awaiting curative endometrial cancer surgery were randomly allocated (1:1) to routine care or dietetic support with a low-energy (800 kcal/day, 76 g protein per day) total diet replacement programme between diagnosis and surgery. Criteria for progression to a definitive trial without design changes comprised recruitment (≥72 participants), engagement (≥75% of dietetic telephone appointments attended), adherence (≥60% of intervention participants reaching ≥5% weight loss), and retention (≥85%). Secondary outcomes were complications graded by masked assessors, symptoms, and changes in weight and fat-free mass. All randomly allocated and eligible participants who underwent surgery were analysed in an intention-to-treat approach. Missing data were not imputed. This trial is registered with ISRCTN, ISRCTN13577800, and is closed to recruitment. Findings Between Nov 6, 2023, and Feb 28, 2025, 78 participants were randomly allocated and 72 were analysed (37 in the intervention group and 35 in the routine care group). Participants attended 85% (SD 24) of their dietetic appointments. Retention was 86% (62 participants). The median period from randomisation to surgery was 28 days (IQR 24–36), during which time 16 (44%) participants in the intervention group and four (12%) in the routine care group lost 5% or more of their weight (odds ratio [OR] 6·00 [95% CI 1·75–20·59]). Intervention participants lost a mean of 5·3 kg (SD 4·1) before surgery, 3·5 kg (95% CI 1·8 to 5·1) more than the routine care participants (–1·8 kg [3·0]), with no evidence of between-group difference in fat-free mass (0·8 kg [95% CI –3·2 to 1·6]). A lower proportion of intervention participants had complications than those in routine care (ten [27%] vs 18 [51%], OR 0·35 [0·13–0·93]). No serious adverse events were reported. Interpretation The trial was feasible: the intervention led to meaningful weight loss, had high engagement, and appeared safe. Evidence suggested fewer postoperative complications in the intervention group. A definitive trial is warranted and could benefit from adaptations to enhance weight loss. Funding National Institute for Health and Care Research.