A randomized study to determine the efficacy of intermittent fasting with time-restricted eating(TRE) in gynecological cancers.

Exploring the efficacy of intermittent fasting with time-restricted eating(TRE) on survival in gynecological cancers: A phase II randomized study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081401

Enrollment

200

Registered

2025-02-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C51-C58- Malignant neoplasms of female genital organs

Interventions

Intervention1: Time-Restricted Eating(TRE): Participants in the TRE group will be instructed to consume meals from 8 am to 8 pm a day,without any calorie restriction. This will be followed by a 12-hou

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women aged 18 to 65 years 2. Eastern Cooperative Oncology Group Performance Status 0 or 1 3. Able and willing to comply with study procedures 4. Willing to undertake required fasting durations 5. Those who give informed consent 6. Epithelial Ovarian cancer Stage III or IV in Complete Remission after completion of planned chemotherapy and cytoreductive surgery (or) 7. Endometrial cancer: High Risk - p53 abnormal with myometrial invasion serous - Stage III, IVA in Complete Remission after surgery, chemotherapy, and radiation 8. 4 weeks post last dose of chemotherapy/radiotherapy

Exclusion criteria

Exclusion criteria: 1. Already engaged in fasting practices (within 3 months of start date) 2. Already on diet/physical activity interventions 3. Diabetic patients 4. Pregnant or breastfeeding females 5. Unwilling or unable to adhere to the requirements of the dietary intervention 6. Carcinosarcoma on histopathology evaluation 7. Relapsed disease

Design outcomes

Primary

Measure	Time frame
2-year PFS rates in the experimental (TRE) arm versus the control armTimepoint: 2 years	—

Secondary

Measure	Time frame
1. Changes in stool microbial profile by 16S rRNA sequencing in the patients in the TRE arm versus the control arm. 2. Impact of TRE on QOL at different timepoints in the two cohorts, ovarian and endometrial cancers, using EORTC-QLQ-OV28 and EORTC-QLQ-EN24 questionnaires respectively. 3. Change in metabolic profile at 6 months for the patients in the TRE arm versus the control arm, in terms of HbA1c, Lipid profile, Serum Insulin and IGF1 levels, HOMA IR, body fat by bioelectrical impedance analysisTimepoint: 0,3,6,12 months	—

Measure

Time frame

1. Changes in stool microbial profile by 16S rRNA sequencing in the patients in the TRE arm versus the control arm. 2. Impact of TRE on QOL at different timepoints in the two cohorts, ovarian and endometrial cancers, using EORTC-QLQ-OV28 and EORTC-QLQ-EN24 questionnaires respectively. 3. Change in metabolic profile at 6 months for the patients in the TRE arm versus the control arm, in terms of HbA1c, Lipid profile, Serum Insulin and IGF1 levels, HOMA IR, body fat by bioelectrical impedance analysisTimepoint: 0,3,6,12 months

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Countries

India

Contacts

Public ContactDrRaja Pramanik

AIIMS, New Delhi

drrajapramanik@gmail.com09654976088

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026