Comparative Study on the Effect of Diet Interventions on Weight Loss in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

Official title

Three-Way Diet Comparison for Weight Loss in Overweight Endometrial Cancer Patients on Fertility-Sparing Regimens: A Randomized Controlled Trial

Overview

In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into three groups. The first group was given Intermittent fasting, the second was given Low-energy balanced diet, the third group underwent routine care for self-weight management. Relevant information such as body morphology ,glycolipid metabolism and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of diet interventions for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

Detailed description

Obesity is recognized as a major risk factor for the development of endometrial cancer. Notably, several retrospective studies have shown that obesity reduces complete remission and pregnancy rates and increases recurrence rates in patients with endometrial cancer and atypical hyperplasia who undergo fertility-sparing treatment. Guidelines or consensus statements for fertility sparing treatment in endometrial cancer recommend weight management.The more accepted weight control diet programs mainly include calorie restriction and dietary changes. In dietary management, studies have shown that intermittent fasting ,low-energy balanced diet can improve patient outcomes. This study therefore aimed to investigate the impact of the different dietary interventions on body morphology and composition, glycolipid metabolism, and tumor outcomes in overweight and obese patients with endometrial cancer and atypical hyperplasia who underwent reproductive function-preserving treatments.In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into second groups. The first group was given Intermittent fasting, the second was given Low-energy balanced diet, the third group underwent routine care for self-weight management.Relevant information such as body morphology ,glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of different dietary interventions management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

Interventions

• Behavioral Multi-Professional Guided '5+2' Intermittent Fasting
  An intervention team of dietitians, doctors and nurses gave patients specific dietary instructions online and offline. Dietary intervention according to the current research basis, intermittent fasting is mainly adopted, that is, the "5+2 light fasting" mode, in which 5 days in a week are non-fasting days, and the other 2 non-consecutive days are fasting days. The recommended daily energy on non-fasting days is based on body weight: standard body weight (kg) ×20; Or according to body composition
• Behavioral Low-energy Balanced Diet
  The target energy intake for women is 1000-1200 kcal/d. Adopt a balanced diet, in which carbohydrates account for 55% to 60% of the total daily energy, fat accounts for 25% to 30% of the total daily energy, protein 10% to 15%. Increase your intake of fiber-rich, low-energy foods to ensure you feel full.
• Behavioral Routine Care for Self-weight Management.
  The relationship between overweightness and obesity and endometrial cancer risk was explained to patients in the control group and their willingness for self-weight management was respected. Communication was maintained with patients from treatment initiation to 6 and 12 months after treatment; patients' questions regarding weight reduction were answered and suggestions were provided regarding nutrition, exercise, and lifestyle management.

Primary outcome measures

• Body Mass Index(BMI) [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]

Secondary outcome measures (12)

• Complete Pathological Remission of Endometrial Cancer Tumor [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• Waist-to-height Ratio(WHtR) [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• Waist-to-hip Ratio(WHR) [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• A Body Shape Index(ABSI) [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• Body Roundness Index(BRI) [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• Waist circumference [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• Hip circumference [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• Triglycerides [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• Cholesterol [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• High density lipoprotein(HDL) [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• Low density lipoprotein [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]
• Fasting glucose [Time frame: Baseline /Month 6 of intervention / Month 12 of intervention]

Eligibility criteria

Inclusion criteria

• age ≥18 years old
• diagnosed as endometrial cancer or atypical hyperplasia
• fertility-preserving therapy
• BMI≥25 kg/m2
• informed consent.

Exclusion criteria

• those with communication barriers
• pregnant women
• medical and surgical serious complications: urinary calculi, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, history of pancreatitis, severe diabetes mellitus, active gallbladder disease, fat dyspepsia, severe cardiovascular and cerebrovascular diseases.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University People's Hospital — Beijing

Identifiers

NCT: NCT07318727 · 2023PHB183-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗