Comparative Study on the Effect of Diet Interventions on Weight Loss in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

Peking University

Status: Enrolling

Conditions: Endometrium Cancer

Treatments: Behavioral: Low-energy Balanced Diet; Behavioral: Routine Care for Self-weight Management.; Behavioral: Multi-Professional Guided '5+2' Intermittent Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT07318727

2023PHB183-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

81 participants in 3 patient groups

Intermittent Fasting Group.

Experimental group

Description:

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.

Treatment:

Behavioral: Multi-Professional Guided '5+2' Intermittent Fasting

Low-energy balanced diet Group.

Experimental group

Description:

Patients in the Low-energy balanced diet group used the target energy intake for women is 1000-1200 kcal/d. Adopt a balanced diet.

Treatment:

Behavioral: Low-energy Balanced Diet

Control Group

Other group

Description:

Patients in the control group underwent routine care for self-weight management.

Treatment:

Behavioral: Routine Care for Self-weight Management.