Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment
- Conditions
- Endometrium Cancer
- Interventions
- Behavioral: Weight management--dietBehavioral: Control groupBehavioral: Weight management--exerciseBehavioral: Weight management--accompanyBehavioral: Weight management--refresh
- Registration Number
- NCT06169449
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
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.
- 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 240
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weight management Group Weight management--diet Patients in the weight management group used a weight management model that included diet, exercise, accompany and refresh. Control Group Control group Patients in the control group underwent routine care for self-weight management. Weight management Group Weight management--accompany Patients in the weight management group used a weight management model that included diet, exercise, accompany and refresh. Weight management Group Weight management--exercise Patients in the weight management group used a weight management model that included diet, exercise, accompany and refresh. Weight management Group Weight management--refresh Patients in the weight management group used a weight management model that included diet, exercise, accompany and refresh.
- Primary Outcome Measures
Name Time Method waist-to-height ratio (WHtR)--physiological parameter 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 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 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 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 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 6 months of intervention Calculate WHR according to the formula"WHR=waist circumference (cm)/hip circumference (cm)"
body shape index (ABSI)--physiological parameter 6 months of intervention Calculate ABSI according to the formula"ABSI= (waist)/(\[BMI\]\^2/3×height\^1/2)"
body roundness index (BRI)--physiological parameter 6 months of intervention Calculate BRI according to the formula"BRI= waist/BMI"
body fat mass (BFM)--physiological parameter 6 months of intervention Measured by the Inbody720 Human Body Composition Analyzer
muscle mass--physiological parameter 6 months of intervention Measured by the Inbody720 Human Body Composition Analyzer
visceral fat area (VFA)--physiological parameter 6 months of intervention Measured by the Inbody720 Human Body Composition Analyzer
fasting glucose--physiological parameter 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 6 months of intervention Calculate LAP according to the formula"LAP= = (waist circumference - 58) × TG level"
waist circumference--physiological parameter 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 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 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 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 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 6 months of intervention Measured by the Inbody720 Human Body Composition Analyzer
basal metabolic rate--physiological parameter 6 months of intervention Measured by the Inbody720 Human Body Composition Analyzer
fasting insulin (FINS)--physiological parameter 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 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.
- Secondary Outcome Measures
Name Time Method Complete remission 6 months of intervention Complete remission indicated by complete endometrial regression and interstitial metaplasia-like changes on histopathology after treatment (without any endometrial atypical hyperplasia or endometrioid adenocarcinoma lesions, as clarified by pathologists)
Recurrence 6 months of intervention After complete remission, the reappearance of endometrioid adenocarcinoma or atypical endometrial hyperplasia during follow-up or after pregnancy or childbearing is defined as recurrence and is diagnosed by the pathologist.
Pregnancy 2 years of intervention The clinical diagnosis was pregnancy.
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, China