Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- waist-to-height ratio (WHtR)--physiological parameter
研究概览
简要总结
In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, 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 weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.
详细描述
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. However, prospective intervention studies on the effectiveness of systematic weight management models in patients receiving reproductive function-preserving treatment for endometrial cancer and atypical hyperplasia are lacking. This study therefore aimed to investigate the impact of the weight management 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 two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, 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 weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years old
- •diagnosed as endometrial cancer or atypical hyperplasia
- •immunohistochemical staining and sequencing of pathological tissue
- •fertility-preserving therapy
- •BMI≥25 kg/m2
- •informed consent.
排除标准
- •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.
结局指标
主要结局
waist-to-height ratio (WHtR)--physiological parameter
时间窗: 6 months of intervention
Calculate WHtR according to the formula"WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"
hip circumference--physiological parameter
时间窗: 6 months of intervention
measured with the subject's body upright, taking the circumference of the body at the horizontal position of the uppermost point of the hip
high density lipoprotein(HDL)--physiological parameter
时间窗: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
homeostatic model assessment of insulin resistance (HOMA-IR) index--physiological parameter
时间窗: 6 months of intervention
Calculate HOMA-IR according to the formula"HOMA-IR= fasting blood glucose (mmol/L) × FINS level (mU/mL)/22.5"
Body Mass Index（BMI）--physiological parameter
时间窗: 6 months of intervention
Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)"
waist-to-hip ratio (WHR)--physiological parameter
时间窗: 6 months of intervention
Calculate WHR according to the formula"WHR=waist circumference (cm)/hip circumference (cm)"
body shape index (ABSI)--physiological parameter
时间窗: 6 months of intervention
Calculate ABSI according to the formula"ABSI= (waist)/(\[BMI\]\^2/3×height\^1/2)"
body roundness index (BRI)--physiological parameter
时间窗: 6 months of intervention
Calculate BRI according to the formula"BRI= waist/BMI"
body fat mass (BFM)--physiological parameter
时间窗: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
muscle mass--physiological parameter
时间窗: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
visceral fat area (VFA)--physiological parameter
时间窗: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
fasting glucose--physiological parameter
时间窗: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
lipid accumulation index (LAP) (female)--physiological parameter
时间窗: 6 months of intervention
Calculate LAP according to the formula"LAP= = (waist circumference - 58) × TG level"
waist circumference--physiological parameter
时间窗: 6 months of intervention
measured with the subject's body upright, abdomen relaxed, both arms hanging down naturally, feet together, and the tape measure placed around the waist; the height was adjusted to the horizontal plane passing through the midpoint of the line between the lower edge of the rib arch and the iliac crest in the mid-axillary line
triglycerides--physiological parameter
时间窗: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
cholesterol--physiological parameter
时间窗: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
low density lipoprotein--physiological parameter
时间窗: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
visceral fat index (VAI)--physiological parameter
时间窗: 6 months of intervention
Calculate VAI according to the formula"VAI= waist/(36.58 + 1.89 × BMI) × triglyceride (TG) level/0.81 × 1.52/high density lipoprotein (HDL) level"
percent body fat (PBF)--physiological parameter
时间窗: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
basal metabolic rate--physiological parameter
时间窗: 6 months of intervention
Measured by the Inbody720 Human Body Composition Analyzer
fasting insulin (FINS)--physiological parameter
时间窗: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
glycated hemoglobin--physiological parameter
时间窗: 6 months of intervention
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
次要结局
- Complete remission(6 months of intervention)
- Recurrence(6 months of intervention)
- Pregnancy(2 years of intervention)
研究者
Xiaodan Li
Director
Peking University People's Hospital