Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

Peking University

Status: Enrolling

Conditions: Endometrium Cancer

Treatments: Behavioral: Weight management--refresh; Behavioral: Weight management--exercise; Behavioral: Weight management--accompany; Behavioral: Weight management--diet; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06169449

RDL2022-49

Details and patient eligibility

About

In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, 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 weight management 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. However, prospective intervention studies on the effectiveness of systematic weight management models in patients receiving reproductive function-preserving treatment for endometrial cancer and atypical hyperplasia are lacking. This study therefore aimed to investigate the impact of the weight management 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 two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, 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 weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥18 years old
• diagnosed as endometrial cancer or atypical hyperplasia
• immunohistochemical staining and sequencing of pathological tissue
• 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)

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240 participants in 2 patient groups

Weight management Group

Experimental group

Description:

Patients in the weight management group used a weight management model that included diet, exercise, accompany and refresh.

Treatment:

Behavioral: Weight management--diet

Behavioral: Weight management--accompany

Behavioral: Weight management--exercise

Behavioral: Weight management--refresh

Control Group

Other group

Description:

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

Treatment:

Behavioral: Control group