Endometrial CancerNCT07879365
Effect of Weight Management on AMPK Activation in the Adjunctive Treatment of Endometrial Cancer
A study testing DEAR-Based Comprehensive Weight Management and Balanced Diet and Self-Directed Exercise in people with Endometrial Cancer, run by Peking University People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- DEAR-Based Comprehensive Weight Management and Balanced Diet and Self-Directed Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing
Xiaodan Li, +8615010305099, lxd_2000_510@163.com
About this study
Official title: A Clinical Study of Weight Management-Induced AMPK Activation as an Adjunctive Treatment for Endometrial Cancer
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.
Read the detailed description
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.
- Conditions
- Endometrial Cancer
- Being tested
- DEAR-Based Comprehensive Weight Management, Balanced Diet and Self-Directed Exercise
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEAR-Based Comprehensive Weight ManagementBehavioural
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.
Balanced Diet and Self-Directed ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DEAR-Based Comprehensive Weight Management | Experimental | 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. Receives: Behavioral: DEAR-Based Comprehensive Weight Management |
| Control Group | Active comparator | 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. Receives: Behavioral: Balanced Diet and Self-Directed Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months of intervention
Secondary outcomes (12)
Body Mass Index
Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height² (m²)".
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodan Li, Peking University People's Hospital
- Investigators
- Xiaodan Li, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879365
- Sponsor's protocol ID
- 2026PHB177-001
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Weight Management-Induced AMPK Activation as an Adjunctive Treatment for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07879365
- Acronym / sponsor ID
- 2026PHB177-001
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEAR-Based Comprehensive Weight Management | Experimental | Behavioral: DEAR-Based Comprehensive Weight ManagementParticipants 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 comparator | Behavioral: Balanced Diet and Self-Directed ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEAR-Based Comprehensive Weight ManagementParticipants 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. | Behavioural | DEAR-Based Comprehensive Weight Management |
| Balanced Diet and Self-Directed ExerciseParticipants 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. | Behavioural | Control Group |
Primary outcome
Pathological Complete Response Rate
Time frame: 6 months of intervention
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.
12 secondary outcomes
Body Mass Index
Time frame: 6 months of intervention
Change in Serum AMP-Activated Protein Kinase (AMPK) Levels
Time frame: 6 months of intervention
Time to Pathological Complete Response
Time frame: 6 months of intervention
Disease Recurrence Rate
Time frame: 6 months of intervention
Time to Disease Recurrence
Time frame: 6 months of intervention
triglycerides
Time frame: 6 months of intervention
cholesterol
Time frame: 6 months of intervention
high density lipoprotein
Time frame: 6 months of intervention
low density lipoprotein
Time frame: 6 months of intervention
fasting glucose
Time frame: 6 months of intervention
glycated hemoglobin
Time frame: 6 months of intervention
fasting insulin
Time frame: 6 months of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaodan Li study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEAR-Based Comprehensive Weight Management and Balanced Diet and Self-Directed Exercise in people with Endometrial Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodan Li (15010305099, lxd_2000_510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response Rate (time frame: 6 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.