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NCT Number: NCT07318727

Comparative Study on the Effect of Diet Interventions on Weight Loss 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 three groups. The first group was given Intermittent fasting, the second was given Low-energy balanced diet, the third group underwent routine care for self-weight management. Relevant information such as body morphology ,glycolipid metabolism 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 diet interventions for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

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Key information

Conditions

Endometrium Cancer Body Weight Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, 100044, China

Location status: Recruiting

Location contact

Xiaodan LI

CONTACT

15010305099

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.The more accepted weight control diet programs mainly include calorie restriction and dietary changes. In dietary management, studies have shown that intermittent fasting ,low-energy balanced diet can improve patient outcomes. This study therefore aimed to investigate the impact of the different dietary interventions 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 second groups. The first group was given Intermittent fasting, the second was given Low-energy balanced diet, the third group underwent routine care for self-weight management.Relevant information such as body morphology ,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 different dietary interventions 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
  • 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

Multi-Professional Guided '5+2' Intermittent Fasting

Behavioral

An intervention team of dietitians, doctors and nurses gave patients specific dietary instructions online and offline. Dietary intervention according to the current research basis, intermittent fasting is mainly adopted, that is, the "5+2 light fasting" mode, in which 5 days in a week are non-fasting days, and the other 2 non-consecutive days are fasting days. The recommended daily energy on non-fasting days is based on body weight: standard body weight (kg) ×20; Or according to body composition measurement lean body mass calculation: BMS =370+21.6× lean body mass (kg), recommended energy intake = BMS × (1.2 ~ 1.3) -500, including protein 20%, fat 25%, carbohydrate 55%. Fasting day energy intake is 1/4 of the usual, about 500 ~ 600kcal.

Low-energy Balanced Diet

Behavioral

The target energy intake for women is 1000-1200 kcal/d. Adopt a balanced diet, in which carbohydrates account for 55% to 60% of the total daily energy, fat accounts for 25% to 30% of the total daily energy, protein 10% to 15%. Increase your intake of fiber-rich, low-energy foods to ensure you feel full.

Routine Care for Self-weight Management.

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 6 and 12 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)

    Time frame: Baseline /Month 6 of intervention / Month 12 of intervention

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

Secondary outcomes

  1. Complete Pathological Remission of Endometrial Cancer Tumor

    Time frame: Baseline /Month 6 of intervention / Month 12 of intervention

    Defined as the absence of any histological evidence of endometrioid adenocarcinoma or atypical hyperplasia in post-treatment endometrial biopsy or curettage specimens, confirmed by two independent pathologists. This state is characterized by complete regression of the tumor lesion, which may be accompanied by benign findings such as stromal metaplasia or atrophic endometrium

  2. Waist-to-height Ratio(WHtR)

    Time frame: Baseline /Month 6 of intervention / Month 12 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)

    Time frame: Baseline /Month 6 of intervention / Month 12 of intervention

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

  4. A Body Shape Index(ABSI)

    Time frame: Baseline /Month 6 of intervention / Month 12 of intervention

    Calculate ABSI according to the formula"ABSI= (waist)/([BMI]^2/3×height^1/2)" Time Frame: 6 months of intervention

  5. Body Roundness Index(BRI)

    Time frame: Baseline /Month 6 of intervention / Month 12 of intervention

    Calculate BRI according to the formula"BRI= waist/BMI" Time Frame: 6 months of intervention

  6. Waist circumference

    Time frame: Baseline /Month 6 of intervention / Month 12 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

  7. Hip circumference

    Time frame: Baseline /Month 6 of intervention / Month 12 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

  8. Triglycerides

    Time frame: Baseline /Month 6 of intervention / Month 12 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

  9. Cholesterol

    Time frame: Baseline /Month 6 of intervention / Month 12 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

  10. High density lipoprotein(HDL)

    Time frame: Baseline /Month 6 of intervention / Month 12 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

  11. Low density lipoprotein

    Time frame: Baseline /Month 6 of intervention / Month 12 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

  12. Fasting glucose

    Time frame: Baseline /Month 6 of intervention / Month 12 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

  13. Fasting insulin

    Time frame: Baseline /Month 6 of intervention / Month 12 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

  14. Glycated hemoglobin

    Time frame: Baseline /Month 6 of intervention / Month 12 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

Study contacts

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

Li Xiaodan, Master

CONTACT

[email protected]

15010305099

Yang Dandan

CONTACT

[email protected]

18710217027

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Three-Way Diet Comparison for Weight Loss in Overweight Endometrial Cancer Patients on Fertility-Sparing Regimens: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

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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