| CTRI Number |
CTRI/2025/02/080764 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving Recovery After Ovarian Cancer Surgery: ERAS Alone vs. ERAS with Prehabilitation. |
|
Scientific Title of Study
|
Evaluation of perioperative outcomes with
enhanced recovery after surgery alone versus
combined enhanced recovery after surgery and
prehabilitation in patients undergoing surgery
for advanced ovarian cancer:- An open labelled
randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room no-016137, Department of Obstetrics & Gynaecology, Level 6,All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India,
Landline no. : 0135-2462940, EMAIL:info@aiimsrishikesh.edu.in
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7015746995 |
| Fax |
|
| Email |
poojagarg6517@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shalini Rajaram |
| Designation |
Professor Gynecologic oncology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room no-016137, Department of Obstetrics & Gynaecology, Level 6,All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India,
Landline no. : 0135-2462940, EMAIL:info@aiimsrishikesh.edu.in
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9810704434 |
| Fax |
|
| Email |
rajaram.shalini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Shalini Rajaram |
| Designation |
Professor Gynecologic oncology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room no-016137, Department of Obstetrics & Gynaecology, Level 6,All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249 203, India,
Landline no. : 0135-2462940, EMAIL:info@aiimsrishikesh.edu.in
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9810704434 |
| Fax |
|
| Email |
rajaram.shalini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pooja |
| Address |
AIIMS Rishikesh |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| POOJA |
All India Institute Of Medical Sciences |
Room no-016137, Department of Obstetrics & Gynaecology, Level 6, Virbhadra Road, Rishikesh Uttarakhand- 249203 India, Landline no. : 0135-2462940, EMAIL:info@aiimsrishikesh.edu.in
Dehradun
UTTARANCHAL |
7015746995
poojagarg6517@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS RISHIKESH. |
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 |
| Comparator Agent |
ERAS |
This group patients will undergo only ERAS as part of standard preoperative protocol. |
| Intervention |
ERAS plus Prehabilitation |
All eligible patients planned for primary upfront or interval debulking surgery after chemotherapy for advanced ovarian cancer will be recruited to the study. For upfront
surgery patients will be hospitalised for work-up and optimisation of general condition which will take around 3 weeks and interventions will be administered under direct
supervision .Patients receiving neoadjuvant chemotherapy will take around 3
months .Initial hospitalisation will be done for work up and treatment planning. During
this period they will be taught prehabilitation measures which includes Physical, Nutritional, Psychological interventions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Advanced ovarian cancer for upfront surgery or after NACT
2. Preoperative schedule that allows from at least 3 weeks for upfront surgery
and upto three months for interval debulking surgery
3. Treatment naive patients
4. Eastern Cooperative Oncology Group Performance Status of up to 2. |
|
| ExclusionCriteria |
| Details |
1. Significant comorbidities or limitation of locomotion that prohibit the patient to
perform prehabilitation activities
2. Emergency surgeries
3. Surgeries by minimally invasive approach (laparoscopy or robotics)
4. Patients suffering from depression and major psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Functional capacity assessment using cardiopulmonary testing by six minute
walk test (6 MWT) and pulmonary function tests using spirometry.
2. Nutritional assessment by serum albumin levels, body mass index, and hand
grip strength test
3. Quality of life assessment using European Organization for Research and
Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-
C30)
4. To measure intraoperative anaesthetic parameters - peak pressure, plateau
pressure, lactate levels, tidal volume, temperature, urine output, ionotropic
requirement, cardiac ejection fraction, problems during weaning off
(extubation failure and immediate need for re-intubation and post extubation
stridor)
5. To measure intraoperative surgical outcomes - duration of surgery in minutes ,
blood loss, transfusion of blood and blood products, cytoreductive outcomes,
surgical complexity score. |
3 weeks to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients with adherence to prehabilitation program as measured
by asking them to maintain and enter daily records of exercises, diet and
pshycological activities in a provided chart if patients are at home or
recording in the proforma if hospitalised.
2. Adverse events of prehabilitation - injuries during exercise, gastrointestinal
symptoms (nausea, vomiting, diarrhoea), withdrawal symptoms due to
cessation of smoking (will take consultation from psychiatry team for opinion
and management if needed) |
3 weeks to 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="1"
Months="6"
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
|
Aim To compare the efficacy of a robust prehabilitation program in combination with enhanced recovery after surgery (ERAS) on functional parameters and perioperative outcomes versus enhanced recovery after surgery (ERAS) alone in women undergoing surgery for advanced ovarian cancer
Objectives
Primary objective a) To compare cardiopulmonary function, nutritional parameters and psychological status before and after implementation of prehabilitation program with enhanced recovery after surgery (ERAS) versus enhanced recovery after surgery (ERAS) alone b) To assess and compare perioperative outcomes in both groups
Secondary objectives a) Adherence to prehabilitation program b) To study adverse events related to prehabilitation
Hypothesis Addition of prehabilitation to enhanced recovery after surgery (ERAS) will improve perioperative outcomes in women undergoing surgery for advanced ovarian cancer.
Methodology All patients presenting with advanced ovarian cancer presenting to our institution after informed consent and meeting inclusion criteria will be included in the study. All eligible patients planned for primary upfront or interval debulking surgery after chemotherapy for advanced ovarian cancer will be recruited to the study. For upfront surgery patients will be hospitalised for work-up and optimisation of general condition which will take around 3 weeks and interventions will be administered under direct supervision .Patients receiving neoadjuvant chemotherapy will take around 3 months .Initial hospitalisation will be done for work up and treatment planning. During this period they will be taught prehabilitation measures. Thereafter this will be recorded in a chart (Annexure 1). Randomization will be done using simple random number table to intervention and control groups (group 1 & 2) in a 1:1 ratio. Allocation to each group will be done using block randomisation in which A group will represent patients undergoing ERAS and prehabilitation and B group will represent patients undergoing only for ERAS. The intervention group will have ERAS plus prehabilitation while control group will undergo ERAS as part of standard preoperative protocol. |