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CTRI Number  CTRI/2025/01/079730 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 09/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy evaluation of Methadone vs Fentanyl for neuropathic pain in head and neck cancers 
Scientific Title of Study   Comparing the analgesic efficacy of Methadone and Fentanyl for neuropathic pain in patients of head and neck cancers: A Equivalent 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  Dr Shabnam Alam  
Designation  Junior Resident (MD), Palliative medicine  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Palliative care unit, Room no-154, Dr BRA IRCH, All India Institute of Medical Sciences, Sri Aurobindo Marg, East Ansari Nagar, New Delhi, PIN-110029

New Delhi
DELHI
110029
India 
Phone  7407005725  
Fax    
Email  shabnamon1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachidanand Jee Bharati 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Room No. 139, First Floor, Dr BRA IRCH, All India Institute of Medical Sciences, Sri Aurobindo Marg, East Ansari nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9968436042  
Fax    
Email  sachidadr@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sachidanand Jee Bharati 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Room No. 139, First Floor, Dr BRA IRCH, All India Institute of Medical Sciences, Sri Aurobindo Marg, East Ansari nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9968436042  
Fax    
Email  sachidadr@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Oncoanaesthesia and Palliative medicine, Dr BRA IRCH, All India Institute of Medical Sciences, New Delhi  
 
Primary Sponsor  
Name  Dr BRA IRCH, All India Institute of Medical Sciences,New Delhi  
Address  Dr BRA IRCH, All India Institute of Medical Sciences,Sri Aurobindo Marg, East Ansari Nagar, Ansari Nagar, New Delhi,PIN-110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shabnam Alam   Dr BRA IRCH, All India Institute of Medical Sciences , New Delhi  Dr BRA IRCH, All India Institute of Medical Sciences, East Ansari Nagar, Ansari Nagar, New Delhi, PIN-110029
New Delhi
DELHI 		 7407005725

shabnamon1999@gmail.com 
Dr Shabnam Alam   National Cancer Institute-AIIMS, Jhajjar  NCI-AIIMS, Badsa, Jhajjar , Haryana, PIN-124105
Jhajjar
HARYANA 		 7407005725

shabnamon1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of ethics committee for post graduate research , AIIMS, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Evaluation of efficacy of Fentanyl for neuropathic pain in patients of head and neck malignancy.  Analgesic optimisation with fentanyl transdermal patch for relief of neuropathic pain in head and neck cancers. 
Intervention  Evaluation of efficacy of Methadone for neuropathic pain in patients of head and neck malignancy.  Analgesic optimisation with methadone syrup for relief of neuropathic pain head and neck cancers. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age greater than 18 years and less than 65 years.
Patients with head and neck malignancy having neuropathic pain who have corrected QT interval ≤ 500 milliseconds, normal range of electrolytes and normal renal profile.
Patients who are already on stronger opioids for more than 14 days and still have pain score more than 4 on NRS.
 
 
ExclusionCriteria 
Details  Patients who have received tablet morphine for less than 2 weeks or on weaker opioids.
Patients with deranged renal functions, dyselectrolytemia and abnormal ECG.
Patients currently in fever.
Patients not willing to apply transdermal patch.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy of Methadone and Fentanyl for neuropathic pain in head and neck malignancies.  Patient will be evaluated at 1 week, 3 week, 5 week, 2 months and 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate reduction in pain after 1 week, 3 week, 5 week, 2 months and 3 months.

To determine the breakthrough pain with the given medications. 		 Patient will be evaluated at 1 week, 3 week, 5 week, 2 months and 3 months. 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/03/2025 
Date of Study Completion (India) 30/06/2026 
Date of First Enrollment (Global)  01/03/2025 
Date of Study Completion (Global) 30/06/2026 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   India has registered more than 11 lakh new cases, out of which 26 % in males and 8% in females. Hence the burden of head and neck cancers are huge in India. Neuropathic pain plays a crucial role in head and neck cancers and many nerves are involved there. For neuropathic pain management , multimodal approaches are tried. Treatment options may include pharmacological interventions, non-pharmacological therapies, interventional procedures and targeted drug delivery system). Pharmacological agents commonly used for neuropathic pain in cancer include anticonvulsants (e.g., gabapentin, pregabalin), antidepressants (e.g., tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors), opioids, and topical agents (e.g., lidocaine patches, capsaicin cream). Non-pharmacological interventions such as physical therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), and psychological interventions (e.g., cognitive-behavioural therapy) are used. Neuropathic pain are chronic and usually traditional analgesics are not much effective. Then Opiods were introduced for neuropathic pain. Most commonly used Opiod is Morphine. Due to it’s side effects sedation, dizziness, and drug-drug interaction, Fentanyl was introduced as a better alternative. Fentanyl patches are generally well-tolerated, with adverse effects primarily related to opioid use, such as constipation, sedation, nausea, and respiratory depression. For neuropathic pain, Methadone was used as in addition to its mu-opioid receptor agonist activity, methadone acts as a non-competitive antagonist at the N-methyl-D-aspartate (NMDA) receptor, potentially modulating central sensitization and reducing hyperalgesia and allodynia associated with neuropathic pain. There are not many studies on Methadone efficacy and its superiority over other Opiods in managing neuropathic pain. To find the efficacy of oral Methadone over Fentanyl in Indian population on neuropathic pain in head and neck cancers we are conducting this study. 
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