RecruitingNot ApplicableNCT06169449

Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

Sponsor

Peking University People's Hospital

Enrollment

240 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Endometrium Cancer

Summary

In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

age ≥18 years old
diagnosed as endometrial cancer or atypical hyperplasia
immunohistochemical staining and sequencing of pathological tissue
fertility-preserving therapy
BMI≥25 kg/m2
informed consent.

Exclusion Criteria3

those with communication barriers
pregnant women
medical and surgical serious complications: urinary calculi, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, history of pancreatitis, severe diabetes mellitus, active gallbladder disease, fat dyspepsia, severe cardiovascular and cerebrovascular diseases.

Interventions

BEHAVIORALWeight management--diet

The diet structure adopts an energy-limited balanced diet. In this structure, the total daily energy intake is reduced by 500\~1000 kcal based on the target energy intake; however, the balance is maintained for the energy supply ratio of the three major nutrients (with carbohydrate, protein, and fat accounting for 55\~60%, 10\~20%, and 15\~30% of the total daily energy, respectively). Combined with the patient's eating habits, the food exchange portion method is used as a guide; each portion providing 90 kcal is considered as one portion. Specific recipes are formulated after calculating the ideal weight and the total daily calorie intake based on activity intensity, determining the number of six food exchange portions and the distribution of three meals according to the total calorie and diet structure, and combining the equivalent food exchange table based on individual tastes and preferences; this ensures patient acceptability and implementation.

BEHAVIORALWeight management--exercise

Exercise goals are divided into four levels based on individual health conditions and personal preferences; these include: cultivating exercise habits, improving cardiopulmonary function, enhancing muscle strength, and improving flexibility. Individualized exercise prescriptions that specify the exercise type, intensity, time, and frequency are formulated.

BEHAVIORALWeight management--accompany

This component involves the inclusion of patients in online management. Online groups are established, daily feedback is obtained regarding weight management implementation, self-sharing is encouraged, and peer support is established; a total of 6 sessions of online health education are provided once every 4 weeks for 20-60 minutes at each session. This includes information regarding the risks associated with overweightness and obesity; weight management benefits; knowledge regarding diet and nutrition, exercise and sports, and behavioral styles; and problem exchange and sharing, among others. Professional support is provided by weekly communication with patients one-on one via WeChat or telephonic conversations. The patient's diet and exercise record sheet are checked, patients are asked questions regarding implementation of the current program and any discomfort or difficulties; corresponding guidance is provided as appropriate.

BEHAVIORALWeight management--refresh

According to the dietary nutrition guidelines for Chinese residents, patients are advised to drink 2500 ml or more of water daily; they are also advised to work and rest regularly to ensure sufficient sleep time, ensure smooth bowel movements, take deep breaths when waking up in the morning, pay attention to the work-rest balance, avoid being sedentary, and stand up and move around at least once every 50 minutes, maintain physical vitality by adjusting daily living habits.

BEHAVIORALControl group

The relationship between overweightness and obesity and endometrial cancer risk was explained to patients in the control group and their willingness for self-weight management was respected. Communication was maintained with patients from treatment initiation to 3 and 6 months after treatment; patients' questions regarding weight reduction were answered and suggestions were provided regarding nutrition, exercise, and lifestyle management.