Comparative Study on the Effect of Diet Interventions on Weight Loss in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorPeking University People's Hospital

About this trial

In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into three groups. The first group was given Intermittent fasting, the second was given Low-energy balanced diet, the third group underwent routine care for self-weight management. Relevant information such as body morphology ,glycolipid metabolism 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 diet interventions for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥18 years old

diagnosed as endometrial cancer or atypical hyperplasia

fertility-preserving therapy

BMI≥25 kg/m2

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multi-Professional Guided '5+2' Intermittent Fasting

    Behavioral

    An intervention team of dietitians, doctors and nurses gave patients specific dietary instructions online and offline. Dietary intervention according to the current research basis, intermittent fasting is mainly adopted, that is, the "5+2 light fasting" mode, in which 5 days in a week are non-fasting days, and the other 2 non-consecutive days are fasting days. The recommended daily energy on non-fasting days is based on body weight: standard body weight (kg) ×20; Or according to body composition measurement lean body mass calculation: BMS =370+21.6× lean body mass (kg), recommended energy intake = BMS × (1.2 \~ 1.3) -500, including protein 20%, fat 25%, carbohydrate 55%. Fasting day energy intake is 1/4 of the usual, about 500 \~ 600kcal.

  • Low-energy Balanced Diet

    Behavioral

    The target energy intake for women is 1000-1200 kcal/d. Adopt a balanced diet, in which carbohydrates account for 55% to 60% of the total daily energy, fat accounts for 25% to 30% of the total daily energy, protein 10% to 15%. Increase your intake of fiber-rich, low-energy foods to ensure you feel full.

  • Routine Care for Self-weight Management.

    Behavioral

    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 6 and 12 months after treatment; patients' questions regarding weight reduction were answered and suggestions were provided regarding nutrition, exercise, and lifestyle management.

Treatment groups

81 Participants
are divided into 3 treatment groups
Group A: Intermittent Fasting Group.Experimental treatment 1 intervention
Group B: Low-energy balanced diet Group.Experimental treatment 1 intervention
Group C: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Body Mass Index(BMI)

Use the Inbody720 to measure height and weight and calculate BMI according to the formula"BMI (= weight (kg)/height2 (m2)

Time frame
Baseline /Month 6 of intervention / Month 12 of intervention

Secondary outcomes

1

Complete Pathological Remission of Endometrial Cancer Tumor

Defined as the absence of any histological evidence of endometrioid adenocarcinoma or atypical hyperplasia in post-treatment endometrial biopsy or curettage specimens, confirmed by two independent pathologists. This state is characterized by complete regression of the tumor lesion, which may be accompanied by benign findings such as stromal metaplasia or atrophic endometrium

Time frame
Baseline /Month 6 of intervention / Month 12 of intervention
2

Waist-to-height Ratio(WHtR)

Calculate WHtR according to the formula"WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"

Time frame
Baseline /Month 6 of intervention / Month 12 of intervention
3

Waist-to-hip Ratio(WHR)

Calculate WHR according to the formula"WHR=waist circumference (cm)/hip circumference (cm)"

Time frame
Baseline /Month 6 of intervention / Month 12 of intervention
4

A Body Shape Index(ABSI)

Calculate ABSI according to the formula"ABSI= (waist)/(\[BMI\]\^2/3×height\^1/2)" Time Frame: 6 months of intervention

Time frame
Baseline /Month 6 of intervention / Month 12 of intervention

Other outcomes

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