Exploring the efficacy of intermittent fasting with time-restricted eating(TRE) on survival in gynecological cancers: A phase II randomized study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 2-year PFS rates in the experimental (TRE) arm versus the control arm
Study Overview
Brief Summary
Rationale/ gaps in existing knowledge: Intermittent fasting(IF) is a novel dietary intervention that has been demonstrated to improve the efficacy of anticancer therapy. Time-restricted eating (TRE), a specific form of IF that restricts the daily eating window without calorie
restriction, is safe, affordable, acceptable, and sustainable for patients. TRE synchronizes the circadian rhythm as well as exerts its metabolic effects mediated by IGF1 and modulation of autophagy. However, the effects of TRE on human cancer prognosis remain unknown because of a lack of randomized clinical trials (RCT).
Novelty: TRE has not been systematically evaluated in an RCT to see its impact on survival in cancer. Objectives We propose to study the impact of TRE on progression-free survival in patients with ovarian and endometrial cancers through an RCT.
Methods We will include patients with epithelial ovarian and endometrial cancers who have
completed their surgery and adjuvant therapies. Diabetics will be excluded. They will be randomized 1:1 to a 6-month TRE schedule (eating time: 8 am to 8 pm without any calorie restriction, followed by 12 hours of fasting) versus the usual diet. The primary endpoint will
be the 2-year PFS rates. The other objectives will include changes in metabolic health parameters (HbA1c, Lipid profile, hs-CRP, IGF1, and Insulin levels) and stool samples for changes in the gut microbiome.
Expected outcome: We expect to find a significantly better PFS in the TRE arm and significant differences in metabolic parameters as well as the gut microbiome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women aged 18 to 65 years
- •Eastern Cooperative Oncology Group Performance Status 0 or 1
- •Able and willing to comply with study procedures
- •Willing to undertake required fasting durations
- •Those who give informed consent
- •Epithelial Ovarian cancer Stage III or IV in Complete Remission after completion of planned chemotherapy and cytoreductive surgery (or)
- •Endometrial cancer: High Risk.
- •p53 abnormal with myometrial invasion serous.
- •Stage III, IVA in Complete Remission after surgery, chemotherapy, and radiation
- •4 weeks post last dose of chemotherapy/radiotherapy.
Exclusion Criteria
- •Already engaged in fasting practices (within 3 months of start date)
- •Already on diet/physical activity interventions
- •Diabetic patients
- •Pregnant or breastfeeding females
- •Unwilling or unable to adhere to the requirements of the dietary intervention
- •Carcinosarcoma on histopathology evaluation
- •Relapsed disease.
Outcomes
Primary Outcomes
2-year PFS rates in the experimental (TRE) arm versus the control arm
Time Frame: 2 years
Secondary Outcomes
- 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.)
Investigators
DrRaja Pramanik
AIIMS, New Delhi