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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
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.
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.
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.
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.
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.
Peking University People's Hospital
Beijing, China, China
RECRUITINGBody Mass Index（BMI）--physiological parameter
Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)"
Time frame: 6 months of intervention
waist-to-height ratio (WHtR)--physiological parameter
Calculate WHtR according to the formula"WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"
Time frame: 6 months of intervention
waist-to-hip ratio (WHR)--physiological parameter
Calculate WHR according to the formula"WHR=waist circumference (cm)/hip circumference (cm)"
Time frame: 6 months of intervention
body shape index (ABSI)--physiological parameter
Calculate ABSI according to the formula"ABSI= (waist)/(\[BMI\]\^2/3×height\^1/2)"
Time frame: 6 months of intervention
body roundness index (BRI)--physiological parameter
Calculate BRI according to the formula"BRI= waist/BMI"
Time frame: 6 months of intervention
visceral fat index (VAI)--physiological parameter
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"
Time frame: 6 months of intervention
lipid accumulation index (LAP) (female)--physiological parameter
Calculate LAP according to the formula"LAP= = (waist circumference - 58) × TG level"
Time frame: 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
Time frame: 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
Time frame: 6 months of intervention
body fat mass (BFM)--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Time frame: 6 months of intervention
muscle mass--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Time frame: 6 months of intervention
percent body fat (PBF)--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Time frame: 6 months of intervention
basal metabolic rate--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Time frame: 6 months of intervention
visceral fat area (VFA)--physiological parameter
Measured by the Inbody720 Human Body Composition Analyzer
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months of intervention
homeostatic model assessment of insulin resistance (HOMA-IR) index--physiological parameter
Calculate HOMA-IR according to the formula"HOMA-IR= fasting blood glucose (mmol/L) × FINS level (mU/mL)/22.5"
Time frame: 6 months of intervention
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)
Time frame: 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.
Time frame: 6 months of intervention
Pregnancy
The clinical diagnosis was pregnancy.
Time frame: 2 years of intervention
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