| CTRI Number |
CTRI/2024/10/075826 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| 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 Oral Methadone and Oral Morphine for Cancer Pain |
|
Scientific Title of Study
|
Comparison of Oral Methadone versus Morphine As a First- Line Strong Opioid for Cancer Pain: A Randomized Double -Blind study |
| 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 Samreen Shaikh |
| Designation |
Fellow in Chronic Pain |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) Medical College, Pune |
| Address |
Department of Anesthesiology and Chronic Pain,3rd Floor Main Building, Bharati Hospital and Research Centre, Bharati Vidyapeeth (DTU) Medical College, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9960838291 |
| Fax |
|
| Email |
samreenshaikh111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varshali Keniya |
| Designation |
Professor and Head of Department |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) Medical College, Pune |
| Address |
Department of Anesthesiology and Chronic Pain,3rd Floor Main Building, Bharati Hospital and Research Centre, Bharati Vidyapeeth (DTU) Medical College, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9881419089 |
| Fax |
|
| Email |
varshali.keniya@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samreen Shaikh |
| Designation |
Fellow in Chronic Pain |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) Medical College, Pune |
| Address |
Department of Anesthesiology and Chronic Pain,3rd Floor Main Building, Bharati Hospital and Research Centre, Bharati Vidyapeeth (DTU) Medical College, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9960838291 |
| Fax |
|
| Email |
samreenshaikh111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Centre, Bharati Vidyapeeth (DTU) Medical College, Dhankawadi, Pune, Maharashtra, India 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Varshali Keniya |
| Address |
Department of Anesthesiology and Chronic Pain,3rd Floor Main Building, Bharati Hospital and Research Centre, Bharati Vidyapeeth (DTU) Medical College, Pune |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Samreen Shaikh |
Bharati Hospital and Research Centre |
Department of Anesthesiology and Chronic Pain,3rd Floor Main Building, Bharati Hospital and Research Centre, Bharati Vidyapeeth (DTU) Medical College, Pune
Pune
MAHARASHTRA |
09960838291
samreenshaikh111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharati Vidyapeeth (Deemed to be University) Medical College, Pune) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Methadone |
Patients in the methadone group will be supplied with tablets containing 5 mg of methadone. The dose consisted of 1/2 to 4 methadone tablets taken twice daily, every 12 h, that is, 2.5– 20 mg/24 h. In view of the uncertain potency ratio between methadone and conventional opioids, the dosing protocol allowed titration to a point where the pain reduction was maximised without side effects. Participants will be instructed to start with a dose of half tablet of methadone every 12 h. After consultation , dose will be gradually increased to 12-hourly dose by half tablet every 2nd day such that by the end of 1 week, they will be given a maximum of 8 tablets/24 h (4 tablets every 12 h). The goal of the titration phase is to reach a target dose so that maximum pain reduction is achieved without causing troublesome side effects. The dose titration phase will be over 2 weeks period and treatment continued for 4 more weeks, allowing 2 weeks for the pain treatment to stabilise and 2 weeks to maintain a steady state, totalling 36 days (6 weeks) of treatment. Monitoring of dose and the analgesic effect will be done on participants on 6 occasions (during the 6 weeks) when the patient comes to the site for a follow-up. Assessment of pain scores and side effects will be repeatedly performed at each of these 6 occasions.
For breakthrough pain, NSAIDs will be recommended orally. If the requirement of NSAIDS will be more than three doses per day, then the daily dose of methadone will be increased by 5 mg/day in two divided doses.
|
| Comparator Agent |
Oral Morphine |
Morphine will be administered in the form of 10 mg tablets, 1/2 to 6 tablets every 4 h, that is, 30–360 mg/24 h. For breakthrough pain, 2 to 3 doses of IR morphine will be allowed per day. If the requirement is more than three breakthrough doses, the daily dose will be increased by the new required dose in divided doses. Monitoring of dose and analgesic effect will be done in the same way as with methadone and during follow-up, pain scores will be evaluated at 6 occasions during the 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All ages between 18 and 70 years
Cancer patients
Numerical Rating Score (NRS) for pain more than or equal to 5
Edmonton Classification System for Cancer Pain (ECS CP) Showing Ne (NEUROPATHIC and NOCIPECTIVE)
Willing for informed consent
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal to participate in the study
Patient not mentally competent to report
From far places who cannot be followed up
Patient with cardiac issues, abnormal baseline ECG and documented arrhythmias |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effectiveness of oral Methadone versus oral Morphine in cancer patient using an 11- point NRS and ESC -CP score in reducing pain in cancer patient |
0,7th,14th,21th,28th,35th,42th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare-
1. Cost effectiveness of Methadone vs Morphine.
2. Side effects of Methadone vs Morphine.
3. Opioid escalation index. |
0,7,14,21,28,35,42 day |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
15/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Malignant pain often have different pain mechanism due to different pain receptors involvement, to adress that a combination of different pain medications are used . Conventional opioids are the backbone of the treatment of cancer pain. Conventional opioids like Morphine acts mainly by binding the Mu opioid receptors .These Mu receptors are found in multiple locations pre-synaptically and post-synaptically. But pain relief in cancer patient via other receptors remains unaddressed. Hence to see the feasibility of methadone with that unaddressed receptors we are conducting this study. Our primary objective in this study is To compare Effectivness of Oral Methadone versus Morphine as a fFrst line Strong Opioid in reducing pain in cancer patient. Our secondary objecties are to compare -1.Cost effectivness of Methadone versus Morphine. 2.Side effects of Methadone versus Morphine. 3.Opioid escalation index.
|