A short-term, intensive weight-loss program before surgery was feasible and produced meaningful weight loss in women with endometrial cancer and excess weight in the randomized ENDO-CARE trial. The intervention was also associated with fewer postoperative complications, although the study was not designed to determine whether weight loss definitively reduces surgical complications. The findings were reported by Koutoukidis et al in The Lancet Obstetrics, Gynaecology, & Women’s Health.
Endometrial cancer is the most common gynecologic cancer in high-income countries and has a particularly strong association with obesity. Obesity also increases the risk of postoperative complications, which can prolong hospital stays and increase health-care costs.
Study Details
The multicenter feasibility randomized controlled trial was conducted at nine gynecologic cancer centers in England. Eligible participants were women aged 18 years or older with a body mass index of at least 28 kg/m² who were awaiting curative surgery for endometrial cancer.
Participants were randomly assigned 1:1 to routine care or a low-energy total diet replacement program with behavioral support. Women in the intervention group were asked to replace all food with four nutritionally complete meal-replacement products per day, providing about 800 kcal and 76 g of protein daily, and received regular telephone support from a dietitian until the day before surgery.
The primary aim was to determine whether a larger definitive trial would be feasible. Prespecified progression criteria included recruitment, attendance at dietitian calls, the proportion of intervention participants losing at least 5% of body weight, participant retention, and safety. Postoperative complications, symptoms, weight change, and fat-free mass were secondary outcomes.
A total of 78 participants were randomly assigned, and 72 were included in the analysis: 37 in the intervention group and 35 in the routine-care group. The median age was 60 years, the mean body mass index was 38.5 kg/m², and the median time from randomization to surgery was 28 days.
Key Findings
Participants attended 85% of expected dietitian appointments, and 86% completed follow-up. Sixteen women in the intervention group, or 44%, lost at least 5% of their body weight before surgery compared with four women, or 12%, receiving routine care.
Mean weight loss before surgery was 5.3 kg with the intervention vs 1.8 kg with routine care, an adjusted between-group difference of 3.5 kg. There was no evidence that the intervention led to greater loss of lean body mass.
Postoperative complications within 30 days after surgery occurred in 27% of participants in the intervention group vs 51% with routine care (odds ratio = 0.35), driven mainly by fewer moderate postoperative complications. However, the investigators noted that this was a feasibility trial not powered for clinical efficacy and that the finding should therefore be considered hypothesis-generating.
No serious adverse events were reported among the 72 participants included in the analysis. Preoperative adverse events were more common with the intervention, most often dizziness, constipation, headache, and diarrhea. Most were grade 1 or 2.
The investigators said the findings support testing the approach in a larger, adequately powered trial. “Our data provide reassurance for both patients and clinicians regarding the safety and feasibility of intentional weight loss in women carrying excess weight as a component of prehabilitation before endometrial cancer surgery,” they wrote.
Dimitrios A. Koutoukidis, PhD, of the Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom, is the corresponding author of the article.
DISCLOSURE: The study was funded by the National Institute for Health and Care Research. For full disclosures of the study authors, visit thelancet.com.
