Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 12, 2023
CompletedFirst Posted
Study publicly available on registry
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
September 3, 2025
August 1, 2025
4.8 years
November 12, 2023
August 31, 2025
Conditions
Outcome Measures
Primary Outcomes (22)
Body 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)"
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)"
6 months of intervention
waist-to-hip ratio (WHR)--physiological parameter
Calculate WHR according to the formula"WHR=waist circumference (cm)/hip circumference (cm)"
6 months of intervention
body shape index (ABSI)--physiological parameter
Calculate ABSI according to the formula"ABSI= (waist)/(\[BMI\]\^2/3×height\^1/2)"
6 months of intervention
body roundness index (BRI)--physiological parameter
Calculate BRI according to the formula"BRI= waist/BMI"
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"
6 months of intervention
lipid accumulation index (LAP) (female)--physiological parameter
Calculate LAP according to the formula"LAP= = (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 formula"HOMA-IR= fasting blood glucose (mmol/L) × FINS level (mU/mL)/22.5"
6 months of intervention
Secondary Outcomes (3)
Complete remission
6 months of intervention
Recurrence
6 months of intervention
Pregnancy
2 years of intervention
Study Arms (2)
Weight management Group
EXPERIMENTALPatients in the weight management group used a weight management model that included diet, exercise, accompany and refresh.
Control Group
OTHERPatients in the control group underwent routine care for self-weight management.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, China, 100044, China
Related Publications (1)
Chen Y, Yang J, Wan Y, Li Q, Yang D, Wang Y, Gong J, Bai L, Liu Y, Li X, Wang J. DEAR model in overweight endometrial cancer patients undergoing fertility-sparing treatment: A randomized controlled trial. Gynecol Oncol. 2024 Jun;185:148-155. doi: 10.1016/j.ygyno.2024.02.017. Epub 2024 Feb 28.
PMID: 38422947DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiaodan Li, Master
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 12, 2023
First Posted
December 13, 2023
Study Start
April 1, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
September 3, 2025
Record last verified: 2025-08