An interventional study of Multi-Professional Guided '5+2' Intermittent Fasting and Low-energy Balanced Diet in Endometrium Cancer, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and 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.
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.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 81 is above the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the Intermittent Fasting group used a 5 days in a week are non-fasting days, and the other 2 non-consecutive days are fasting days.
Behavioral: Multi-Professional Guided '5+2' Intermittent Fasting
Patients in the Low-energy balanced diet group used the target energy intake for women is 1000-1200 kcal/d. Adopt a balanced diet.
Behavioral: Low-energy Balanced Diet
Patients in the control group underwent routine care for self-weight management.
Behavioral: Routine Care for Self-weight Management.
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.
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.
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.
Body Mass Index(BMI)
Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Complete Pathological Remission of Endometrial Cancer Tumor
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
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Waist-to-height Ratio(WHtR)
Calculate WHtR according to the formula"WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Waist-to-hip Ratio(WHR)
Calculate WHR according to the formula"WHR=waist circumference (cm)/hip circumference (cm)"
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
A Body Shape Index(ABSI)
Calculate ABSI according to the formula"ABSI= (waist)/(\[BMI\]\^2/3×height\^1/2)" Time Frame: 6 months of intervention
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Body Roundness Index(BRI)
Calculate BRI according to the formula"BRI= waist/BMI" Time Frame: 6 months of intervention
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Waist circumference
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: Baseline /Month 6 of intervention / Month 12 of intervention
Hip circumference
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: Baseline /Month 6 of intervention / Month 12 of intervention
Triglycerides
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: Baseline /Month 6 of intervention / Month 12 of intervention
Cholesterol
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: Baseline /Month 6 of intervention / Month 12 of intervention
High density lipoprotein(HDL)
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: Baseline /Month 6 of intervention / Month 12 of intervention
Low density lipoprotein
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: Baseline /Month 6 of intervention / Month 12 of intervention
Fasting glucose
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: Baseline /Month 6 of intervention / Month 12 of intervention
Fasting insulin
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: Baseline /Month 6 of intervention / Month 12 of intervention
Glycated hemoglobin
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: Baseline /Month 6 of intervention / Month 12 of intervention
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