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.

Comparative Evaluation of Methadone and Morphine in Managing Breathlessness, Pain and Quality of life in Lung Carcinoma Patients- A Randomised control trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084907

Enrollment

150

Registered

2025-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C343- Malignant neoplasm of lower lobe,bronchus or lung Health Condition 2: C340- Malignant neoplasm of main bronchus Health Condition 3: C342- Malignant neoplasm of middle lobe,bronchus or lung Health Condition 4: C348- Malignant neoplasm of overlappingsites of bronchus and lung Health Condition 5: C384- Malignant neoplasm of pleura Health Condition 6: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung Health Condition 7: C341- Malignant neoplasm of upper lobe,b

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To assess and compare the efficacy of methadone and morphine in managing breathlessness using Visual Analogue Scale.Timepoint: 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

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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.

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Countries

India

Contacts

Public ContactDr BRAJESH KUMAR RATRE

All India Institute of Medical Sciences, New Delhi

brajesh.ratre@gmail.com8696156799

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026