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CTRI Number  CTRI/2025/10/096437 [Registered on: 24/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Home-Based Nutrition and Exercise Program for Women with Ovarian Cancer 
Scientific Title of Study   A randomised controlled trial evaluating the impact of multimodal home based personalised PREhabilitation on Nutrition and PERI-operative outcomes in women with OVARian malignancy (PREPARE-OVARY 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  Dr Seema Singhal  
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room no 705 Seventh Floor Mother and Child Block All India Institute of Medical Sciences New Delhi

New Delhi
DELHI
110029
India 
Phone  919818291001  
Fax    
Email  drseemasinghal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Singhal  
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room no 705 Seventh Floor Mother and Child Block All India Institute of Medical Sciences New Delhi

New Delhi
DELHI
110029
India 
Phone  919818291001  
Fax    
Email  drseemasinghal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Seema Singhal  
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room no 705 Seventh Floor Mother and Child Block All India Institute of Medical Sciences New Delhi

New Delhi
DELHI
110029
India 
Phone  919818291001  
Fax    
Email  drseemasinghal@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Seema Singhal   All India Institute of Medical Sciences  Department of Obstetrics and Gynaecology Mother and Child Block All India Institute of Medical Sciences New Delhi
New Delhi
DELHI 
98182 91001

drseemasinghal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Name of Ethics Committee as Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention Group: Home based multimodal Prehabilitation program  Participants in this group will receive a home-based multimodal prehabilitation program designed to support them through our Gynae Cancer Care mobile application, which enables personalized home-care monitoring. The program includes individualized nutritional counseling, guided yoga and exercise sessions, psychological support, and education on coping and stress-management strategies along with Standard routine preoperative care provided at AIIMS to help improve overall health and readiness for surgery while undergoing neo adjuvant chemotherapy. program: providing yoga therapy, nutritional support, psychosexual support and assessment of adherence using Gynae Cancer Care app. 
Comparator Agent  Standard Care Group  Participants will receive the usual preoperative care i.e maintain physical activity, including walking 3-4 km daily, following a high-protein diet, and performing daily incentive spirometry as advised in routine care in our institution. provided at AIIMS for surgery while undergoing neo adjuvant chemotherapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  62.00 Year(s)
Gender  Female 
Details  1 Neoadjuvant chemotherapy followed by interval cytoreductive surgery.
2 Above 18 years
3 ECOG Performance Score of 0-3 
 
ExclusionCriteria 
Details  1 Pre-existing inflammatory disorders such as major infections, burns, open wounds, fistulas, acute trauma, chronic organ diseases like congestive heart failure, rheumatoid arthritis, chronic kidney or liver disease, or AIDS.

2 Pre-diagnosed myopathy, malabsorption syndromes, recent pulse steroid therapy or major surgery within the past 30 days, a final pathological diagnosis of benign disease, planned primary cytoreduction for newly diagnosed epithelial ovarian cancer (EOC), recurrent ovarian cancer, non-epithelial ovarian malignancies, or those undergoing palliative care.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in malnutrition scores before and after the prehabilitation program will be compared between experimental and control groups, along with adherence assessment in the experimental arm.
Short-term surgical outcomes—including hospital stay, blood loss, transfusion needs, and 30-day complications (Clavien-Dindo classification)—will also be analyzed 
An 8-week home-based prehabilitation program starting after the first chemotherapy cycle will evaluate its effects on clinical, nutritional, and functional outcomes. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="378"
Sample Size from India="378" 
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   N/A 
Date of First Enrollment (India)   03/11/2025 
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="3"
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  

Malnutrition is a well-established hallmark of cancer, with prevalence rates ranging from 25-70 percentage 1–6. In cancer patients, malnutrition results from nausea, fatigue, gastrointestinal obstruction, psychological distress, alterations in nutrient metabolism, resting energy expenditure and cytokine-mediated inflammation. Cytokine release from neoplastic processes promotes anorexia, increases resting energy expenditure, accelerates protein breakdown, and inhibits fat metabolism, leading to a rapid protein-calorie malnutrition, diminished lean body mass, and impaired physical functionality. This significantly impacts all aspects of cancer care, contributing to delayed postoperative recovery, reduced tolerance to therapy, and increased mortality rates 7. In India, cancer-specific mechanisms of malnutrition are compounded by a high baseline prevalence of malnutrition in the general population. The country accounts for 42% of underweight women, primarily due to poverty, food insecurity, limited access to healthcare, and gender inequality 8. Notably, many women in India occupy a lower social status, further exacerbating their vulnerability to malnutrition. Gynecological cancers, significantly contribute to women’s morbidity and mortality. Malnutrition affects 30-60 percentage of these women, increasing surgical risks and reducing quality of life. A study in Gujarat observed malnutrition prevalence as 88.3% among Indian women with gynecological cancers 9. Malnutrition adversely impacts treatment responses and survival rates, necessitating early identification and tailored nutritional interventions to enhance recovery and quality of life. Patients with ovarian cancer are at a significantly higher risk of malnutrition compared to those with other gynecological cancers, with protein energy malnutrition and cachexia affecting up to 81.4% of cases. Epithelial Ovarian cancers (EOC) are the most common out of all the ovarian malignancy are rising in incidence. Surgery and chemotherapy remains the mainstay of treatment. At diagnosis, 66.7% of epithelial ovarian cancer (EOC) patients are malnourished, leading to increased complications and extended hospital stays. Malnutrition correlates with shorter survival rates, necessitating comprehensive nutritional assessments and individualized treatment plans for these high-risk patients to improve outcomes in these women. Despite the recognized importance of malnutrition in cancer care, systematic nutritional screening is not yet standard practice in many institutions 10. This is primarily due to lack of an efficient, feasible modality. Malnutrition can be assessed through dietary history, physical signs, and laboratory indicators. Validated tools such as NRS-2002, MNA, MST, and PG-SGA are effective in oncological populations, with PG-SGA (Annexure II given in additional supplementary information). recommended as the gold standard11. The novel Global Leadership Initiative on Malnutrition (GLIM) has proposed new diagnostic criteria incorporating inflammation and muscle mass assessment (sarcopenia). However, the applicability of GLIM for women with EOC remains unexamined.

 
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