Clinical trial NCT06169449: Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment
Official title: Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrium Cancer
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Mass Index（BMI）--physiological parameter
timeFrame: 6 months of intervention
measure: waist-to-height ratio (WHtR)--physiological parameter
timeFrame: 6 months of intervention
measure: waist-to-hip ratio (WHR)--physiological parameter
timeFrame: 6 months of intervention
measure: body shape index (ABSI)--physiological parameter
timeFrame: 6 months of intervention
measure: body roundness index (BRI)--physiological parameter
timeFrame: 6 months of intervention
measure: visceral fat index (VAI)--physiological parameter
timeFrame: 6 months of intervention
measure: lipid accumulation index (LAP) (female)--physiological parameter
timeFrame: 6 months of intervention
measure: waist circumference--physiological parameter
timeFrame: 6 months of intervention
measure: hip circumference--physiological parameter
timeFrame: 6 months of intervention
measure: body fat mass (BFM)--physiological parameter
timeFrame: 6 months of intervention
measure: muscle mass--physiological parameter
timeFrame: 6 months of intervention
measure: percent body fat (PBF)--physiological parameter
timeFrame: 6 months of intervention
measure: basal metabolic rate--physiological parameter
timeFrame: 6 months of intervention
measure: visceral fat area (VFA)--physiological parameter
timeFrame: 6 months of intervention
measure: triglycerides--physiological parameter
timeFrame: 6 months of intervention
measure: cholesterol--physiological parameter
timeFrame: 6 months of intervention
measure: high density lipoprotein(HDL)--physiological parameter
timeFrame: 6 months of intervention
measure: low density lipoprotein--physiological parameter
timeFrame: 6 months of intervention
measure: fasting glucose--physiological parameter
timeFrame: 6 months of intervention
measure: fasting insulin (FINS)--physiological parameter
timeFrame: 6 months of intervention
measure: glycated hemoglobin--physiological parameter
timeFrame: 6 months of intervention
measure: homeostatic model assessment of insulin resistance (HOMA-IR) index--physiological parameter
timeFrame: 6 months of intervention
Secondary outcomes:
measure: Complete remission
timeFrame: 6 months of intervention
measure: Recurrence
timeFrame: 6 months of intervention
measure: Pregnancy
timeFrame: 2 years of intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Xiaodan Li, Master
role: STUDY_CHAIR
References: