| CTRI Number |
CTRI/2025/04/084907 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the relief given by Syrup Methadone with the Tablet Morphine for the treatment of shortness of breath, pain and improving quality of life in Lung Cancer patients. |
|
Scientific Title of Study
|
Comparative Evaluation of Methadone and Morphine in Managing Breathlessness, Pain and Quality of life in Lung Carcinoma Patients- A Randomised control 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 Tilak R |
| Designation |
Junior Resident- Department of Onco-Anaesthesia and Palliative Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 154, Palliative Care Unit, First floor, Dr B.R.Ambedkar Institute Rotary Cancer Hospital, AIIMS-New Delhi campus
New Delhi
DELHI
110029
India |
| Phone |
9444111680 |
| Fax |
|
| Email |
tilakbrightindia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BRAJESH KUMAR RATRE |
| Designation |
Associate Professor- Department of Onco-Anaesthesia and Palliative Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No.242, Second Floor, Dr B.R.Ambedkar Institute Rotary Cancer Hospital, AIIMS-New Delhi campus
New Delhi
DELHI
110029
India |
| Phone |
8696156799 |
| Fax |
|
| Email |
brajesh.ratre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BRAJESH KUMAR RATRE |
| Designation |
Associate Professor- Department of Onco-Anaesthesia and Palliative Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No.242, Second Floor, Dr B.R.Ambedkar Institute Rotary Cancer Hospital, AIIMS-New Delhi campus
New Delhi
DELHI
110029
India |
| Phone |
8696156799 |
| Fax |
|
| Email |
brajesh.ratre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Onco-Anaesthesia and Palliative Medicine, Dr.B.R.Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Ansari Nagar, New Delhi-110029, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr BRAJESH KUMAR RATRE |
Dr.B.R.Ambedkar Institute Rotary Cancer Hospital |
Palliative Medicine OPD, Department of Onco-Anaesthesia and Palliative Medicine, Room No.60, Ground floor, Dr.B.R.Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110029,
New Delhi
DELHI |
8696156799
brajesh.ratre@gmail.com |
| Dr BRAJESH KUMAR RATRE |
National Cancer Institute |
Palliative Medicine OPD, Department of Onco-Anaesthesia and Palliative Medicine, D wing, First floor, OPD Building, National Cancer Institute, Badsa, Jhajjar, Haryana- 124105.
Jhajjar
HARYANA |
8696156799
brajesh.ratre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C343||Malignant neoplasm of lower lobe,bronchus or lung, (2) ICD-10 Condition: C340||Malignant neoplasm of main bronchus, (3) ICD-10 Condition: C342||Malignant neoplasm of middle lobe,bronchus or lung, (4) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung, (5) ICD-10 Condition: C384||Malignant neoplasm of pleura, (6) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, (7) ICD-10 Condition: C341||Malignant neoplasm of upper lobe,bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug- Syrup Methadone |
Syrup Methadone initially started at the dose of 2.5MG two times a day, then gradually up-titrated based on symptom response, followed-up for a period of 12 weeks for the study purpose and thereafter the treatment continued until the symptoms resolves. |
| Comparator Agent |
Drug- Tablet Morphine (Instant Release) |
Tablet Morphine (Instant Release) initially started at the dose of 5MG three times a day, then gradually up-titrated based on symptom response, followed-up for a period of 12 weeks for the study purpose and thereafter the treatment continued until the symptoms resolves. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.All the patients diagnosed with Lung cancer with age greater than 18 years.
2.Patients with Dyspnoea of MMRC grade greater than 1.
3.Ability to provide informed consent to participate in the study.
4.Patients fall under Eastern Cooperative Oncology Group performance status classification I to III
|
|
| ExclusionCriteria |
| Details |
1.Patients who are already getting treated with WHO Step 3 Analgesics.
2.Patients diagnosed with Chronic Kidney disease or Deranged renal function test - Serum Urea lab value greater than 50mg/dL and Serum Creatinine lab value greater than 1.4mg/dL.
3.Patients with deranged liver function test - liver enzymes- SGOT lab value greater than 115U/L, SGPT lab value greater than 150U/L and ALP lab value greater than 350U/L
4.Patients with Significant Electrolyte abnormalities with symptoms.
5.Patients with Prolonged QTc interval - value greater than 450 in ECG
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the efficacy of methadone and morphine in managing breathlessness using Visual Analogue Scale. |
To assess and compare the efficacy of methadone and morphine in managing breathlessness using Visual Analogue Scale- at Baseline/Pre-intervention, Post Intervention- Day 1, Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the efficacy of methadone and morphine in Pain management using Numerical Rating Scale.
2.Assessing Quality of life using the EORTC QLQ-C30 and EORTC QLQ-LC29 questionnaires.
3.Compliance and tolerance of drugs to the patients
4.To monitor and compare the side effects. |
Baseline/Pre-intervention, Post Intervention at the end of 1st week, 2nd week, 4th week, 8th week and 12th week during the follow-up visits. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="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
|
INTRODUCTION: According to WHO, Globally Lung cancer is the most common cancer type and the most common cause of cancer death. In India, among cancer incidence in males, lung cancer ranked the highest. The major symptoms in lung cancer are Cough, Chest pain, Breathlessness, Anorexia and fatigue. The prevalence of breathlessness in primary lung cancers is more than 70%.Among opioids, low dose Morphine is standard therapy in relieving breathlessness in Cancer, COPD and Heart failure patients. There are some case series that demonstrated Methadone effect in breathlessness but not well established. As, Methadone is comparatively more cheaper and more potent than Morphine , knowledge and experience in using Methadone for breathlessness and pain will reduce symptom burden in economically poor cancer patients and patients with severe symptoms. AIM: To assess and compare the efficacy of methadone and morphine in managing breathlessness, pain and quality of life in Lung Cancer patients. This study is an open labelled, Randomized control trial, planned as a Non Inferiority trail METHADOLOGY: Ø Patients diagnosed with Carcinoma Lung will be selected using inclusion and exclusion criteria . Ø Informed consent will be obtained and then patients randomly distributed in Study arm and Control arm using the random numbers generated through online software- Research Randomizer. Ø Patients will be started initially with, Syrup Methadone 2.5mg BD in Study arm and Tablet Morphine (IR) 5mg TDS in Control arm Then gradually uptitrated based on symptom response. Ø The baseline symptom burden score for Breathlessness, Pain and Quality of Life will be assessed using Visual Analogue Scale(VAS), Numerical Rating Scale (NRS) and EORTC QLQ-C30 & EORTC QLQ-LC29 Questionnaire respectively Ø The efficacy of Methadone and Morphine in treating Breathlessness, Pain and Quality of Life will be assessed with baseline and different predefined time points. Ø The collected data will be analysed with the use of SPSS 29 or STATA 18. Quantitative data will be presented in Mean with Standard deviation (SD) or Median with Interquartile Range. A p-value of less than 0.05 will be considered as Statistical significance. |