Comparative Study on the Effect of Diet Interventions on Weight Loss in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment
Three-Way Diet Comparison for Weight Loss in Overweight Endometrial Cancer Patients on Fertility-Sparing Regimens: A Randomized Controlled Trial
1 other identifier
interventional
81
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
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
First Submitted
Initial submission to the registry
August 4, 2024
CompletedStudy Start
First participant enrolled
January 10, 2025
CompletedFirst Posted
Study publicly available on registry
January 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJanuary 6, 2026
January 1, 2026
1.2 years
August 4, 2024
January 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Mass Index(BMI)
Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)
Baseline /Month 6 of intervention / Month 12 of intervention
Secondary Outcomes (14)
Complete Pathological Remission of Endometrial Cancer Tumor
Baseline /Month 6 of intervention / Month 12 of intervention
Waist-to-height Ratio(WHtR)
Baseline /Month 6 of intervention / Month 12 of intervention
Waist-to-hip Ratio(WHR)
Baseline /Month 6 of intervention / Month 12 of intervention
A Body Shape Index(ABSI)
Baseline /Month 6 of intervention / Month 12 of intervention
Body Roundness Index(BRI)
Baseline /Month 6 of intervention / Month 12 of intervention
- +9 more secondary outcomes
Study Arms (3)
Intermittent Fasting Group.
EXPERIMENTALPatients 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.
EXPERIMENTALPatients 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
OTHERPatients in the control group underwent routine care for self-weight management.
Interventions
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.
Eligibility Criteria
You may qualify if:
- age ≥18 years old
- diagnosed as endometrial cancer or atypical hyperplasia
- 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, 100044, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Li Xiaodan, 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
August 4, 2024
First Posted
January 6, 2026
Study Start
January 10, 2025
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
January 6, 2026
Record last verified: 2026-01