Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

Conditions
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Endometrium Cancer

Intervention / Treatment
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* Behavioral: Weight management--diet
* Behavioral: Weight management--exercise
* Behavioral: Weight management--accompany
* Behavioral: Weight management--refresh
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight management Group<br>Patients in the weight management group used a weight management model that included diet, exercise, accompany and refresh. | Behavioral: Weight management--diet<br>* The diet structure adopts an energy-limited balanced diet. In this structure, the total daily energy intake is reduced by 500 1000 kcal based on the target energy intake; however, the balance is maintained for the energy supply ratio of the three major nutrients (with carbohydrate, protein, and fat accounting for 55 60%, 10 20%, and 15 30% of the total daily energy, respectively). Combined with the patient's eating habits, the food exchange portion method is used as a guide; each portion providing 90 kcal is considered as one portion. Specific recipes are formulated after calculating the ideal weight and the total daily calorie intake based on activity intensity, determining the number of six food exchange portions and the distribution of three meals according to the total calorie and diet structure, and combining the equivalent food exchange table based on individual tastes and preferences; this ensures patient acceptability and implementation.<br>Behavioral: Weight management--exercise<br>* Exercise goals are divided into four levels based on individual health conditions and personal preferences; these include: cultivating exercise habits, improving cardiopulmonary function, enhancing muscle strength, and improving flexibility. Individualized exercise prescriptions that specify the exercise type, intensity, time, and frequency are formulated.<br>Behavioral: Weight management--accompany<br>* This component involves the inclusion of patients in online management. Online groups are established, daily feedback is obtained regarding weight management implementation, self-sharing is encouraged, and peer support is established; a total of 6 sessions of online health education are provided once every 4 weeks for 20-60 minutes at each session. This includes information regarding the risks associated with overweightness and obesity; weight management benefits; knowledge regarding diet and nutrition, exercise and sports, and behavioral styles; and problem exchange and sharing, among others. Professional support is provided by weekly communication with patients one-on one via WeChat or telephonic conversations. The patient's diet and exercise record sheet are checked, patients are asked questions regarding implementation of the current program and any discomfort or difficulties; corresponding guidance is provided as appropriate.<br>Behavioral: Weight management--refresh<br>* According to the dietary nutrition guidelines for Chinese residents, patients are advised to drink 2500 ml or more of water daily; they are also advised to work and rest regularly to ensure sufficient sleep time, ensure smooth bowel movements, take deep breaths when waking up in the morning, pay attention to the work-rest balance, avoid being sedentary, and stand up and move around at least once every 50 minutes, maintain physical vitality by adjusting daily living habits.<br>|
| Other: Control Group<br>Patients in the control group underwent routine care for self-weight management. | Behavioral: Control group<br>* 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 3 and 6 months after treatment; patients' questions regarding weight reduction were answered and suggestions were provided regarding nutrition, exercise, and lifestyle management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index（BMI）--physiological parameter | Use the Inbody720 to measure height and weight and calculate BMI according to the formulaBMI (= weight (kg)/height2 (m2) | 6 months of intervention | 
| waist-to-height ratio (WHtR)--physiological parameter | Calculate WHtR according to the formulaWHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm) | 6 months of intervention | 
| waist-to-hip ratio (WHR)--physiological parameter | Calculate WHR according to the formulaWHR=waist circumference (cm)/hip circumference (cm) | 6 months of intervention | 
| body shape index (ABSI)--physiological parameter | Calculate ABSI according to the formulaABSI= (waist)/([BMI]^2/3×height^1/2) | 6 months of intervention | 
| body roundness index (BRI)--physiological parameter | Calculate BRI according to the formulaBRI= waist/BMI | 6 months of intervention | 
| visceral fat index (VAI)--physiological parameter | Calculate VAI according to the formulaVAI= waist/(36.58 + 1.89 × BMI) × triglyceride (TG) level/0.81 × 1.52/high density lipoprotein (HDL) level | 6 months of intervention | 
| lipid accumulation index (LAP) (female)--physiological parameter | Calculate LAP according to the formulaLAP= = (waist circumference - 58) × TG level | 6 months of intervention | 
| waist circumference--physiological parameter | 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 | 6 months of intervention | 
| hip circumference--physiological parameter | measured with the subject's body upright, taking the circumference of the body at the horizontal position of the uppermost point of the hip | 6 months of intervention | 
| body fat mass (BFM)--physiological parameter | Measured by the Inbody720 Human Body Composition Analyzer | 6 months of intervention | 
| muscle mass--physiological parameter | Measured by the Inbody720 Human Body Composition Analyzer | 6 months of intervention | 
| percent body fat (PBF)--physiological parameter | Measured by the Inbody720 Human Body Composition Analyzer | 6 months of intervention | 
| basal metabolic rate--physiological parameter | Measured by the Inbody720 Human Body Composition Analyzer | 6 months of intervention | 
| visceral fat area (VFA)--physiological parameter | Measured by the Inbody720 Human Body Composition Analyzer | 6 months of intervention | 
| triglycerides--physiological parameter | 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. | 6 months of intervention | 
| cholesterol--physiological parameter | 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. | 6 months of intervention | 
| high density lipoprotein(HDL)--physiological parameter | 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. | 6 months of intervention | 
| low density lipoprotein--physiological parameter | 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. | 6 months of intervention | 
| fasting glucose--physiological parameter | 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. | 6 months of intervention | 
| fasting insulin (FINS)--physiological parameter | 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. | 6 months of intervention | 
| glycated hemoglobin--physiological parameter | 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. | 6 months of intervention | 
| homeostatic model assessment of insulin resistance (HOMA-IR) index--physiological parameter | Calculate HOMA-IR according to the formulaHOMA-IR= fasting blood glucose (mmol/L) × FINS level (mU/mL)/22.5 | 6 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission | 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) | 6 months of intervention | 
| Recurrence | 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. | 6 months of intervention |