Endometrium CancerNCT07318727
Comparative Study on the Effect of Diet Interventions on Weight Loss in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment
A study testing Multi-Professional Guided '5+2' Intermittent Fasting, Low-energy Balanced Diet and Routine Care for Self-weight Management. in people with Endometrium Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometrium Cancer
- What is being tested?
- Multi-Professional Guided '5+2' Intermittent Fasting, Low-energy Balanced Diet and Routine Care for Self-weight Management.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age ≥18 years old
- diagnosed as endometrial cancer or atypical hyperplasia
- fertility-preserving therapy
- BMI≥25 kg/m2
- informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Xiaodan LI, 15010305099
About this study
Official title: Three-Way Diet Comparison for Weight Loss in Overweight Endometrial Cancer Patients on Fertility-Sparing Regimens: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Endometrium Cancer
- Being tested
- Multi-Professional Guided '5+2' Intermittent Fasting, Low-energy Balanced Diet, Routine Care for Self-weight Management.
- Keywords
- Endometrial Neoplasms, Dietary Patterns, Body Weight
- Medical subject headings
- Endometrial Neoplasms, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Professional Guided '5+2' Intermittent FastingBehavioural
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 DietBehavioural
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.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting Group. | Experimental | 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. Receives: Behavioral: Multi-Professional Guided '5+2' Intermittent Fasting |
| Low-energy balanced diet Group. | Experimental | Patients in the Low-energy balanced diet group used the target energy intake for women is 1000-1200 kcal/d. Adopt a balanced diet. Receives: Behavioral: Low-energy Balanced Diet |
| Control Group | Other | Patients in the control group underwent routine care for self-weight management. Receives: Behavioral: Routine Care for Self-weight Management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index(BMI)
Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)
Measured: Baseline /Month 6 of intervention / Month 12 of intervention
Secondary outcomes (14)
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
Measured: 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)"
Measured: 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)"
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline /Month 6 of intervention / Month 12 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start10 Jan 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrium CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodan Li, Peking University People's Hospital
- Investigators
- Li Xiaodan, Master, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318727
- Sponsor's protocol ID
- 2023PHB183-001
- Status last verified
- Jan 2026
- First submitted
- 4 Aug 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Way Diet Comparison for Weight Loss in Overweight Endometrial Cancer Patients on Fertility-Sparing Regimens: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07318727
- Acronym / sponsor ID
- 2023PHB183-001
- Conditions
- Endometrium Cancer
- Keywords
- Endometrial Neoplasms, Dietary Patterns, Body Weight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting Group. | Experimental | Behavioral: Multi-Professional Guided '5+2' Intermittent FastingPatients 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. |
| Low-energy balanced diet Group. | Experimental | Behavioral: Low-energy Balanced DietPatients in the Low-energy balanced diet group used the target energy intake for women is 1000-1200 kcal/d. Adopt a balanced diet. |
| Control Group | Other | Behavioral: Routine Care for Self-weight Management.Patients in the control group underwent routine care for self-weight management. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age ≥18 years old
- diagnosed as endometrial cancer or atypical hyperplasia
- fertility-preserving therapy
- BMI≥25 kg/m2
- informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Professional Guided '5+2' Intermittent FastingAn 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. | Behavioural | Intermittent Fasting Group. |
| Low-energy Balanced DietThe 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. | Behavioural | Low-energy balanced diet Group. |
| Routine Care for Self-weight Management.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. | Behavioural | Control Group |
Primary outcome
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)
14 secondary outcomes
Complete Pathological Remission of Endometrial Cancer Tumor
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Waist-to-height Ratio(WHtR)
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Waist-to-hip Ratio(WHR)
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
A Body Shape Index(ABSI)
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Body Roundness Index(BRI)
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Waist circumference
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Hip circumference
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Triglycerides
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Cholesterol
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
High density lipoprotein(HDL)
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Low density lipoprotein
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Fasting glucose
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Fasting insulin
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Glycated hemoglobin
Time frame: Baseline /Month 6 of intervention / Month 12 of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Xiaodan, Master study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Professional Guided '5+2' Intermittent Fasting, Low-energy Balanced Diet and Routine Care for Self-weight Management. in people with Endometrium Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Xiaodan, Master (15010305099, lxd_2000_510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index(BMI) (time frame: Baseline /Month 6 of intervention / Month 12 of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.