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NCT06901778Not yet recruiting

Application-Assisted Weight Management in Endometrial Cancer Fertility Preservation

Adaptive Behavioral Intervention Application for Weight Control in Obese/Overweight Endometrial Cancer Patients in Fertility Preservation:A Randomized Clinical Trial

Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
106 (estimated)
First submitted
24 Mar 2025
Start date
31 Mar 2025
Primary completion date
31 Mar 2027
Lead sponsor
Peking University People's Hospital
NCT number
NCT06901778

What you commit to

  • Study type: Interventional
  • Planned participants: 106
  • From 31 Mar 2025 to the primary completion date, 31 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently using weight-loss medications
  • Undergoing anticoagulant therapy that may affect body composition, weight, or energy expenditure

Other illness

  • High-grade or p53-mutated (p53mut) endometrial cancer
  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.