Diet approaches to help overweight women with endometrial cancer preserve fertility and lose weight
Three-Way Diet Comparison for Weight Loss in Overweight Endometrial Cancer Patients on Fertility-Sparing Regimens: A Randomized Controlled Trial
This study will see if intermittent fasting or a low-energy balanced diet help overweight or obese women with endometrial cancer lose weight and improve metabolic and tumor-related outcomes while they undergo fertility-preserving treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07318727 on ClinicalTrials.gov |
What this trial studies
Overweight and obese women with endometrial cancer or atypical hyperplasia who are receiving fertility-preserving therapy are randomly assigned to one of three groups: a multi-professional guided '5+2' intermittent fasting program, a low-energy balanced diet, or routine self-managed care. The study collects body morphology and composition measures, glycolipid metabolism markers, molecular typing, and tumor outcomes during follow-up. Researchers will compare weight change, metabolic profiles, and tumor response across groups to determine the safety and effectiveness of the dietary approaches. The goal is to identify whether specific diet interventions can improve remission, metabolic health, and fertility outcomes in this population.
Who should consider this trial
Good fit: Adult women (≥18) with endometrial cancer or atypical hyperplasia, BMI ≥25 kg/m2, currently receiving fertility-preserving treatment and able to provide informed consent are eligible.
Not a fit: People with BMI <25, those not undergoing fertility-preserving therapy, pregnant women, or patients with the specified serious medical comorbidities are unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, these dietary programs could help reduce weight, improve metabolic health, and potentially support better tumor and fertility outcomes for overweight women preserving fertility.
How similar studies have performed: Retrospective and metabolic studies suggest intermittent fasting and low-energy diets can improve weight and glycolipid markers, but randomized data specifically in fertility-sparing endometrial cancer patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Peking University People's Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Li Xiaodan, Master
- Email: lxd_2000_510@163.com
- Phone: 15010305099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.