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CTRI Number  CTRI/2026/01/102644 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to find out if a prehabilitation program with exercise, nutrition, and mental preparation before major cancer surgery helps cancer patients recover faster and have fewer complications compared to standard care. 
Scientific Title of Study   Impact of Enhanced Prehabilitation on Postoperative Outcomes in Major Oncological Surgeries: A Randomized Controlled Trial 
Trial Acronym  PREP-CANCER 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gunasekhar Vamsi Krishna 
Designation  Senior Resident 
Affiliation  AIIMS Mangalagiri 
Address  Room No. 414, Department Of Surgical Oncology, 4th Floor, OPD Building, AIIMS Mangalagiri, Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  8897968297  
Fax    
Email  vamsizeus69@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemant Kumar Singh 
Designation  Assistant Professor 
Affiliation  AIIMS Mangalagiri 
Address  Room No. 416, Department Of Surgical Oncology, 4th Floor, OPD Building, AIIMS Mangalagiri, Mangalagiri, 522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  8903306321  
Fax    
Email  hemant.surgicaloncology@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Hemant Kumar Singh 
Designation  Assistant Professor 
Affiliation  AIIMS Mangalagiri 
Address  Room No. 416, Department Of Surgical Oncology, 4th Floor, OPD Building, AIIMS Mangalagiri, Mangalagiri, 522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  8903306321  
Fax    
Email  hemant.surgicaloncology@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Gunasekhar Vamsi Krishna 
Address  Room No. 414, Department Of Surgical Oncology, 4th Floor, OPD Building, AIIMS Mangalagiri, Mangalagiri, 522503 
Type of Sponsor  Other [SELF] 
 
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 Gunasekhar Vamsi Krishna  AIIMS Mangalagiri  Room No. 414, Department Of Surgical Oncology, 4th Floor, OPD Building, AIIMS Mangalagiri, Mangalagiri, 522503
Guntur
ANDHRA PRADESH 		 8897968297

vamsizeus69@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Mangalagiri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Enhanced Prehabilitation group  Patients will receive standard prehabilitation plus resistance training, aerobic exercises, handgrip strengthening, and meditation. Exercise and Physiotherapy (intervention group): Resistance Training: Strength-based exercises to increase muscle mass. Handgrip Training: 3 sets of 10 repetitions per hand (total 20 reps daily). Squats: 3 sets of 10 repetitions (with or without support; minimum 5 reps, maximum 10 per set). Quadriceps Strengthening: 3 sets of 10 repetitions per leg. Lower Leg Strengthening: 3 sets of 10 repetitions targeting the calf and anterior compartment muscles. Dumbbell Exercises: 3 sets of 10 repetitions for biceps, using 2–5 kg weights based on body weight. Core Strengthening: Wall-leaning exercises for 20–60 seconds, based on tolerability. Resistance Band Exercises: Shoulder exercises, as tolerated (minimum 5 repetitions, maximum 10, 3 sets). Aerobic Exercises: Walking (at least 3000 steps/day) Cycling (minimum 10 minutes/day) Meditation: 15 minutes daily morning or evening. Adjustable Resistance Training: Patients will have control over the resistance level based on their initial comfort, strength, and endurance. As they progress, they will be encouraged to gradually increase the resistance to match their improving physical capacity. Heart Rate Monitoring: Training will be conducted within a safe heart rate range, with an upper limit of 130 beats per minute (bpm). Safety and Monitoring: The session will be immediately paused if the patient experiences any discomfort, including shortness of breath, dyspnea, dizziness, chest pain, or excessive fatigue. Patients will be allowed to rest and will resume training only when they feel ready. Supervision & Guidance: Patients will be monitored throughout the session to ensure proper technique, avoid overexertion, and optimize the effectiveness of the intervention. Gradual Progression: Adjustments to intensity and duration will be made based on individual tolerance, ensuring a balance between challenge and safety. Duration: Patients will receive prehabilitation for 2 weeks before surgery. Adherence and progress will be monitored daily.  
Comparator Agent  Standard Prehabilitation Group  Patients will receive standard prehabilitation, including nutritional supplementation, pulmonary exercises (spirometry), meditation and routine physical activity.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adult patients (greater than 18 years) undergoing primary Head and neck, Thoracic, Abdominal and Pelvic oncologic surgery.
Histopathologically confirmed malignancies requiring surgical intervention.
 
 
ExclusionCriteria 
Details  Patients undergoing palliative surgery or non-curative resections.
Patients with pre-existing bone diseases, and neuromuscular disorders affecting muscle function., heart dysfunction, liver dysfunction, renal dysfunction.
Severe renal or hepatic dysfunction affecting metabolism and muscle mass.
Patients who decline consent.
Patients with recurrent and metastatic disease.
Patients with age greater than 75 years 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Postoperative complications according to Clavien-Dindo Classification
 		 30 days post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
ICU and hospital stays
 		 till discharge from hospital 
Nutritional and muscle status  30 days postoperative period 
 
Target Sample Size   Total Sample Size="324"
Sample Size from India="324" 
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)   23/02/2026 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vamsizeus69@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Randomized controlled trial in patients undergoing major oncological surgery comparing standard prehabilitation with enhanced prehabilitation. Standard care includes nutrition supplementation and incentive spirometry. Enhanced program adds resistance training aerobic exercises cycling meditation and handgrip strengthening. The aim is to assess whether enhanced prehabilitation reduces postoperative complications and improves recovery. The study will also look at hospital length of stay functional recovery and quality of life. This is a single center study conducted at AIIMS Mangalagiri with equal randomization into two groups. Findings may guide the adoption of cost effective prehabilitation protocols in cancer surgery preparation in India. 
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