| CTRI Number |
CTRI/2025/02/081401 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized study to determine the efficacy of intermittent fasting with time-restricted eating(TRE) in gynecological cancers. |
|
Scientific Title of Study
|
Exploring the efficacy of intermittent fasting with time-restricted eating(TRE) on survival in gynecological cancers: A phase II randomized study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRaja Pramanik |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 160F
1st floor
Dr. BRA IRCH
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
09654976088 |
| Fax |
|
| Email |
drrajapramanik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raja Pramanik |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 160F
1st floor
Dr. BRA IRCH
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
09654976088 |
| Fax |
|
| Email |
drrajapramanik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRaja Pramanik |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 160F
1st floor
Dr. BRA IRCH
AIIMS New Delhi
DELHI
110029
India |
| Phone |
09654976088 |
| Fax |
|
| Email |
drrajapramanik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research(ICMR)
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research(ICMR) |
| Address |
Indian Council of Medical Research Headquarters, AIIMS Campus Temple, Ansari Nagar East, New Delhi, Delhi- 110029 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raja Pramanik |
AIIMS, New Delhi |
Room No. 160 F,
1st floor,
Department of Medical Oncology
Dr. BRA- IRCH,
All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
9654976088
drrajapramanik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-TRE |
Participants in this group will be instructed to continue their usual diet without any time restriction. |
| Intervention |
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-hour fasting period, including sleep. Water and non-caloric beverages will be allowed.
DURATION OF INTERVENTION will be 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 2-year PFS rates in the experimental (TRE) arm versus the control arm |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 analysis |
0,3,6,12 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |