Clinical trial NCT06901778: Application-Assisted Weight Management in Endometrial Cancer Fertility Preservation
Official title: Adaptive Behavioral Intervention Application for Weight Control in Obese/Overweight Endometrial Cancer Patients in Fertility Preservation:A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Mobile Applications
Weight Management
Keywords: Endometrial Neoplasms
Mobile Applications
Weight Loss
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a single-center, prospective, randomized controlled trial targeting endometrial cancer (EC) patients undergoing fertility-sparing treatment at Peking University People's Hospital from March 2025 to March 2027. The aim is to evaluate the efficacy of an intelligent mobile application (APP) based on the Adaptive Behavioral Intervention (ABI) framework in weight management for obese or overweight endometrial cancer patients receiving fertility preservation therapy. Additionally, the study seeks to explore its potential advantages in improving body mass index (BMI), tumor regression, and glucose and lipid metabolism profiles.

Detailed description: Endometrial cancer is one of the most common malignancies of the female reproductive tract, with obesity being a closely associated factor in its development and progression. According to the American Cancer Society, 57% of endometrial cancer cases are linked to obesity, and a 5-unit increase in body mass index (BMI) elevates the risk of EC by 50%. Overweight or obesity adversely impacts treatment efficacy and reduces survival rates in EC patients. In recent years, the incidence of EC has shown a trend toward younger populations, posing significant threats to the health and quality of life of patients undergoing fertility-sparing treatment. The Adaptive Behavioral Intervention (ABI) framework emphasizes real-time adjustments based on individual feedback and progress to optimize behavioral change and health outcomes. Integrating smart application (APP) technology can provide more convenient and personalized weight management support for EC patients undergoing fertility preservation. By continuously collecting and analyzing behavioral data, the intervention strategy can be dynamically tailored, thereby enhancing the effectiveness and sustainability of the intervention. Currently, there is a paucity of research on comprehensive weight management interventions incorporating intelligent APPs for obese or overweight EC patients in fertility-sparing treatment. This study aims to investigate the efficacy of an ABI-based smart APP in weight management for this population through a randomized controlled trial (RCT).

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 25 kg/m²
* Histologically confirmed endometrial carcinoma via diagnostic curettage, hysteroscopic endometrial biopsy, or needle biopsy
* Clinical FIGO 2009 stage IA disease: No evidence of extrauterine metastasis or myometrial invasion on imaging (MRI/CT)
* ECOG \< 2
* Active desire to preserve fertility
* Fertility-preserving treatment
* Willingness to participate and signed informed consent

Exclusion Criteria:

* High-grade or p53-mutated (p53mut) endometrial cancer
* Currently using weight-loss medications
* Pregnant or breastfeeding
* Presence of communication barriers that prevent understanding and participation in the informed consent process
* Participation in other weight-loss programs
* Inability to safely engage in unsupervised physical activities
* Undergoing anticoagulant therapy that may affect body composition, weight, or energy expenditure
* Severe comorbidities: urinary system stones, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, history of pancreatitis, severe diabetes, active gallbladder disease, fat malabsorption, severe cardiovascular and cerebrovascular diseases
* Presence of unstable medical conditions: uncontrolled hypertension, diabetes, unstable angina, transient ischemic attack, other cancers currently under treatment, Crohn's disease

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Secondary outcomes:
measure: Waist circumference (WC)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Hip circumference (HC)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Waist-to-height ratio (WHtR)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Waist-to-hip ratio (WHR)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Body shape index (ABSI)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Body roundness index (BRI)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Visceral fat index (VAI)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Lipid accumulation index (LAP)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Triglycerides
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Cholesterol
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: High density lipoprotein (HDL)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Low density lipoprotein (LDL)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Fasting glucose
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Fasting insulin (FINS)
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Glycated hemoglobin
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Weight efficacy
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Exercise adherence
timeFrame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
measure: Complete response (CR)
timeFrame: One year of intervention
measure: Application usage frequency
timeFrame: one year 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
role: STUDY_CHAIR
References: