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NCT Number: NCT06169449

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

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.

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Key information

Conditions

Endometrium Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, China, 100044

Location status: Recruiting

Location contact

Li

CONTACT

+8615010305099

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight management--diet

Behavioral

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.

Weight management--exercise

Behavioral

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.

Weight management--accompany

Behavioral

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.

Weight management--refresh

Behavioral

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.

Control Group

Behavioral

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.

Primary outcomes

  1. Body Mass Index（BMI）--physiological parameter

    Time frame: 6 months of intervention

    Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)"

  2. waist-to-height ratio (WHtR)--physiological parameter

    Time frame: 6 months of intervention

    Calculate WHtR according to the formula"WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"

  3. waist-to-hip ratio (WHR)--physiological parameter

    Time frame: 6 months of intervention

    Calculate WHR according to the formula"WHR=waist circumference (cm)/hip circumference (cm)"

  4. body shape index (ABSI)--physiological parameter

    Time frame: 6 months of intervention

    Calculate ABSI according to the formula"ABSI= (waist)/([BMI]^2/3×height^1/2)"

  5. body roundness index (BRI)--physiological parameter

    Time frame: 6 months of intervention

    Calculate BRI according to the formula"BRI= waist/BMI"

  6. visceral fat index (VAI)--physiological parameter

    Time frame: 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"

  7. lipid accumulation index (LAP) (female)--physiological parameter

    Time frame: 6 months of intervention

    Calculate LAP according to the formula"LAP= = (waist circumference - 58) × TG level"

  8. waist circumference--physiological parameter

    Time frame: 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

  9. hip circumference--physiological parameter

    Time frame: 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

  10. body fat mass (BFM)--physiological parameter

    Time frame: 6 months of intervention

    Measured by the Inbody720 Human Body Composition Analyzer

  11. muscle mass--physiological parameter

    Time frame: 6 months of intervention

    Measured by the Inbody720 Human Body Composition Analyzer

  12. percent body fat (PBF)--physiological parameter

    Time frame: 6 months of intervention

    Measured by the Inbody720 Human Body Composition Analyzer

  13. basal metabolic rate--physiological parameter

    Time frame: 6 months of intervention

    Measured by the Inbody720 Human Body Composition Analyzer

  14. visceral fat area (VFA)--physiological parameter

    Time frame: 6 months of intervention

    Measured by the Inbody720 Human Body Composition Analyzer

  15. triglycerides--physiological parameter

    Time frame: 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.

  16. cholesterol--physiological parameter

    Time frame: 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.

  17. high density lipoprotein(HDL)--physiological parameter

    Time frame: 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.

  18. low density lipoprotein--physiological parameter

    Time frame: 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.

  19. fasting glucose--physiological parameter

    Time frame: 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.

  20. fasting insulin (FINS)--physiological parameter

    Time frame: 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.

  21. glycated hemoglobin--physiological parameter

    Time frame: 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.

  22. homeostatic model assessment of insulin resistance (HOMA-IR) index--physiological parameter

    Time frame: 6 months of intervention

    Calculate HOMA-IR according to the formula"HOMA-IR= fasting blood glucose (mmol/L) × FINS level (mU/mL)/22.5"

Secondary outcomes

  1. Complete remission

    Time frame: 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)

  2. Recurrence

    Time frame: 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.

  3. Pregnancy

    Time frame: 2 years of intervention

    The clinical diagnosis was pregnancy.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodan Li, Master

CONTACT

[email protected]

+8615010305099

Yiqian Chen, Master

CONTACT

[email protected]

+8617864238409

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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