| 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
|
|
|
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
|
|
|
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. |