Effect of Weight Management on AMPK Activation in the Adjunctive Treatment of Endometrial Cancer
A Clinical Study of Weight Management-Induced AMPK Activation as an Adjunctive Treatment for Endometrial Cancer
1 other identifier
interventional
160
1 country
1
Brief Summary
This study will randomly assign overweight or obese patients with endometrial cancer undergoing fertility-sparing treatment to two groups. The intervention group will receive a comprehensive weight management program based on the DEAR principles of Diet, Exercise, Accompany, and Refresh, including intermittent fasting and structured aerobic exercise. The control group will receive balanced dietary guidance and self-directed exercise. Both groups will receive family and healthcare support, sleep monitoring, and stress-management support. By evaluating pathological complete response, body mass index, glucose and lipid metabolism, and serum AMP-activated protein kinase (AMPK) levels, this study aims to determine the effectiveness and safety of DEAR-based weight management in patients with endometrial cancer undergoing fertility-sparing treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2026
CompletedFirst Posted
Study publicly available on registry
October 16, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
Study Completion
Last participant's last visit for all outcomes
December 31, 2027
October 16, 2026
October 1, 2026
12 months
October 10, 2026
October 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pathological Complete Response Rate
Pathological complete response is defined as the absence of residual atypical endometrial hyperplasia or endometrioid adenocarcinoma on histopathological examination following fertility-sparing treatment, as confirmed by pathologists.
6 months of intervention
Secondary Outcomes (12)
Body Mass Index
6 months of intervention
Change in Serum AMP-Activated Protein Kinase (AMPK) Levels
6 months of intervention
Time to Pathological Complete Response
6 months of intervention
Disease Recurrence Rate
6 months of intervention
Time to Disease Recurrence
6 months of intervention
- +7 more secondary outcomes
Study Arms (2)
DEAR-Based Comprehensive Weight Management
EXPERIMENTALParticipants will receive a 12-week comprehensive weight management program based on the DEAR principles of Diet, Exercise, Accompany, and Refresh. The program includes an intermittent fasting diet and aerobic exercise three times per week, along with family and healthcare support, sleep monitoring, and stress management.
Control Group
ACTIVE COMPARATORParticipants will be informed about the relationship between overweight or obesity and the risk and prognosis of endometrial cancer. Self-management will be guided by participants' preferences, without a structured weight management program. Participants will continue to receive family member supervision and check-in support, follow-up support from healthcare professionals, sleep monitoring, and stress management sessions. General recommendations on diet, physical activity, and lifestyle modification will be provided.
Interventions
Participants will receive a 12-week comprehensive weight management program based on the DEAR principles of Diet, Exercise, Accompany, and Refresh. The program includes an intermittent fasting diet and aerobic exercise three times per week, along with family and healthcare support, sleep monitoring, and stress management.
Participants will receive a balanced diet and engage in self-directed exercise for 12 weeks. They will be encouraged to engage in physical activity independently according to their individual circumstances, while also receiving support from family members and healthcare professionals, sleep monitoring, and stress-management support.
Eligibility Criteria
You may qualify if:
- Aged 18 years or older.
- Diagnosed with endometrial cancer.
- Have undergone immunohistochemical staining of pathological tissue samples and sequencing analysis.
- Receiving fertility-sparing treatment.
- Body mass index ≥ 24 kg/m².
- Provided written informed consent to participate in the study.
You may not qualify if:
- Patients with communication difficulties.
- Pregnant patients.
- Patients with severe medical or surgical comorbidities, including urinary tract stones, a history of renal failure or severe renal impairment, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, a history of pancreatitis, severe diabetes mellitus, active gallbladder disease, disorders of fat digestion, severe cardiovascular disease, cerebrovascular disease, or other serious comorbidities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiaodan Li
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 10, 2026
First Posted
October 16, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
October 16, 2026
Record last verified: 2026-10