An interventional study of DEAR-Based Comprehensive Weight Management and Balanced Diet and Self-Directed Exercise in Endometrial Cancer, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
Obesity is an important risk factor for endometrial cancer and may influence the response to progestin-based fertility-sparing treatment through insulin resistance, hormonal dysregulation, and chronic inflammation. Current clinical guidelines recommend weight management for patients undergoing fertility-sparing treatment. However, further prospective evidence is needed to determine whether comprehensive lifestyle interventions can improve pathological response in overweight or obese patients with endometrial cancer. The DEAR framework integrates dietary management, physical activity, family and healthcare support, and sleep and stress management to improve metabolic health and promote sustainable lifestyle changes. AMP-activated protein kinase (AMPK), a key regulator of cellular energy metabolism, may be involved in metabolic regulation and progestin sensitivity. However, the relationship between lifestyle-induced metabolic changes, AMPK, and tumor response remains unclear. Therefore, this study aims to evaluate the clinical value of DEAR-based comprehensive weight management as an adjunct to fertility-sparing treatment and explore the association between metabolic regulation and treatment response.
1,347 studies on the registry are indexed under Endometrial Neoplasms; 452 are open to participants now.
This study's planned enrollment of 160 is above the median of 70 across 954 interventional studies indexed under Endometrial Neoplasms.
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Exclusion Criteria:
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.
Behavioral: DEAR-Based Comprehensive Weight Management
Participants 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.
Behavioral: Balanced Diet and Self-Directed Exercise
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.
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.
Time frame: 6 months of intervention
Body Mass Index
Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height² (m²)".
Time frame: 6 months of intervention
Change in Serum AMP-Activated Protein Kinase (AMPK) Levels
Serum AMP-activated protein kinase (AMPK) concentrations will be measured using an enzyme-linked immunosorbent assay (ELISA).
Time frame: 6 months of intervention
Time to Pathological Complete Response
Time to pathological complete response will be defined as the interval from randomization to the first histopathological confirmation of complete response following fertility-sparing treatment.
Time frame: 6 months of intervention
Disease Recurrence Rate
The proportion of participants with histopathologically confirmed disease recurrence after achieving pathological complete response during the follow-up period.
Time frame: 6 months of intervention
Time to Disease Recurrence
Time to disease recurrence will be defined as the interval from the first documented pathological complete response to the first histopathologically confirmed disease recurrence.
Time frame: 6 months of intervention
triglycerides
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Time frame: 6 months of intervention
cholesterol
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Time frame: 6 months of intervention
high density lipoprotein
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Time frame: 6 months of intervention
low density lipoprotein
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Time frame: 6 months of intervention
fasting glucose
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Time frame: 6 months of intervention
glycated hemoglobin
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Time frame: 6 months of intervention
fasting insulin
About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer.
Time frame: 6 months of intervention
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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