| CTRI Number |
CTRI/2026/01/100326 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Preparation of Patients for surgery to improve recovery in head and neck cancer |
|
Scientific Title of Study
|
Prehabilitation and Early Recovery After Surgery (ERAS) in head and neck cancer patients undergoing surgery (PreERA) |
| Trial Acronym |
PreERA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RESHMA AMBULKAR |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
ADVANCE CENTRE FOR TRAINING RESEARCH AND EDUCATION IN CANCER |
| Address |
Department Of Anaesthesia
Room 248, Paymaster Shodhika, ACTREC, Tata Memorial Centre, Homi Bhabha National Institute. Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9821790448 |
| Fax |
|
| Email |
RAMBULKAR@HOTMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shriyal Prabhudesai |
| Designation |
Junior Resident |
| Affiliation |
ADVANCE CENTRE FOR TRAINING RESEARCH AND EDUCATION IN CANCER |
| Address |
Department of Anaesthesia
Room 248, Paymaster Shodhika, ACTREC, Tata Memorial Centre, Homi Bhabha National Institute. Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
8208014855 |
| Fax |
|
| Email |
SHRIYAL.PRABHUDESAI@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shriyal Prabhudesai |
| Designation |
Junior Resident |
| Affiliation |
ADVANCE CENTRE FOR TRAINING RESEARCH AND EDUCATION IN CANCER |
| Address |
Room 248, Paymaster Shodhika, ACTREC, Tata Memorial Centre, Homi Bhabha National Institute. Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
8208014855 |
| Fax |
|
| Email |
SHRIYAL.PRABHUDESAI@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| The support will provided by Institutional funding (ACTREC,TMC, Navi Mumbai, Maharashtra) |
|
|
Primary Sponsor
|
| Name |
Institution |
| Address |
Tata Memorial Centre Research Administration Council (TRAC), Advanced Centre for Training Research and Education in Cancer (ACTREC), Tata Memorial Centre (TMC), Kharghar Navi Mumbai, 410210 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shriyal Prabhudesai |
Advanced Centre for Training Research and Education in Cancer |
ACTREC, Tata Memorial Centre, Homi Bhabha National Institute. Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra
Mumbai (Suburban)
MAHARASHTRA |
8208014855
SHRIYAL.PRABHUDESAI@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medical Optimisation |
Medical optimisation of chronic health conditions such as hypertension, DM, COPD if any other by the physician. |
| Intervention |
Nutritional optimization |
All patients will be evaluated for nutritional status and further optimization. Nutritional support will be given only if required as per assessment. |
| Intervention |
Physiotherapy |
2-3 weeks of individualized home based exercise program focussing on jaw mobility, neck and shoulder function and respiratory and aerobic capacity. Each exercise prescription will depend upon relevant demographic and clinical characteristics, physical stability, any safety considerations and current exercise activities at home. The set of repititions will be increased by one after assessing at the end of each week based on compliance and fatigue. |
| Intervention |
Psychological support |
This includes multiple sessions over 3 weeks with a focus on Cognitive Behavioural Therapy (CBT), Motivational Interviewing (MI), and Mindfulness-Based Stress Reduction (MBSR) techniques to help patients in quitting tobacco/alcohol and manage stress before and after surgery. |
| Intervention |
Speech and swallowing therapy |
Counselling for expected functional outcomes in different post-operative stages, Speech intelligibility, food consistency and quantity restrictions
followed by exercises like Oro-motor exercises including lip, tongue and jaw, laryngeal strengthening, pharyngeal strengthening
|
| Comparator Agent |
Standard arm |
Patients in the standard arm will continue to receive the routine perioperative care practices that are currently followed in our hospital |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients (18 -70 years) diagnosed with head and neck cancer scheduled for elective Bite composite resections for carcinoma of buccal mucosa in joint clinic |
|
| ExclusionCriteria |
| Details |
1.Previous head and neck cancer treatment
2.Perioperative chemotherapy
3.Patients undergoing emergency surgery
4.Any condition that prevents patients from undergoing regular exercises- locomotor limitations preluding exercise training adherence to the program
5.Cognitive deterioration preventing adherence to program
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay in patients undergoing elective head neck cancer surgeries with and without prehabilitation and ERAS protocol. |
From day of surgery till day of discharge from hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in 6-minute walk test (6 MWT), Maximum Mouth Opening (MMO), Cervical Range Of Motion (CROM) with prehabilitation |
the values before starting prehabilitation(T0), and before surgery(T1) and at 90 days after surgery (T3) |
| Major morbidity: Total incidence of postoperative complications after surgery assessed by Clavien-Dindo grading syst readmission rate re-exploration rate |
within 90 days |
| Functional outcome in speech and swallowing by Performance Status Scale for Head and Neck Cancer speech and diet |
before starting prehabilitation and before surgery and day of discharge |
| Change in haemoglobin, albumin, weight |
from decision of surgery till surgery |
| incidence of Post Operative Pulmonary Complications |
till discharge |
| 30 days mortality |
death from any cause prior to discharge from hospital or within 30 days of surgery |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
16/01/2026 |
| 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) |
Open to Recruitment |
|
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
|
This stratified randomized controlled trial evaluates the impact of a structured multidisciplinary prehabilitation program integrated with Enhanced Recovery After Surgery protocols on outcomes in patients undergoing elective head and neck cancer surgery with flap reconstruction. Adults aged from 18 years to 90 years with buccal mucosa carcinoma scheduled for bite composite resection will be randomized to either standard perioperative care or a comprehensive prehabilitation program delivered for 2 weeks preoperatively. The intervention includes medical optimization, nutritional assessment and supplementation, anemia correction, structured physiotherapy, respiratory training, speech and swallowing therapy, and psychological counselling for stress and addiction management. ERAS components will be implemented perioperatively in both groups. The primary outcome is postoperative length of hospital stay. Secondary outcomes include postoperative morbidity , pulmonary complications, ICU stay, readmissions, mortality, functional recovery, nutritional status, speech and swallowing function, and behavioral modification. Outcomes will be assessed at baseline, preoperatively, discharge, and 90 days post-surgery. Data will be analyzed on an intention-to-treat basis using appropriate regression and mixed-effects modeling. This study aims to determine whether integrating prehabilitation with ERAS improves physiological reserve, accelerates recovery, and reduces complications compared with standard care in head and neck cancer surgery. |