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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07318727 · 2023PHB183-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗