A Study to See if Adding Small Dose of Methadone to Morphine Helps Control Severe Cancer Pain

Efficacy and safety of low dose Methadone as an Adjuvant to morphine in patients with refractory cancer pain: A phase III Open label, Randomized controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105859

Enrollment

Registered

2026-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: C801- Malignant (primary) neoplasm, unspecified

Interventions

Intervention1: Morphine plus low-dose Methadone: Methadone 2.5 mg twice daily(oral), titrated weekly by 2.5 mg/dose to a maximum of 15 mg/day. Morphine continued as standard morphine therapy and adju

Eligibility

Inclusion criteria

Inclusion criteria: Adults (greater than or equal to 18 years) with advanced cancer and moderate to severe pain (NRS greater than or equal to 5) despite stable morphine therapy (greater than or equal to 120 mg/day oral morphine equivalent daily dose).

Exclusion criteria

Exclusion criteria: 1.Known QTc prolongation, arrhythmias, or concomitant QTc-prolongation drugs. 2.Current use of methadone or other NMDA antagonists (e.g. Ketamine).

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving greater than or equal to 30% reduction in mean pain intensity from baseline to Week 4, measured using a 0 to 10 Numeric Rating Scale (NRS).Timepoint: Baseline and at 4 weeks	—

Secondary

Measure	Time frame
Mean change in total daily oral morphine equivalent dose (mg) will be measured from baseline to Week 4.Timepoint: Baseline & at 4 weeks.;Change in global quality of life scores & symptom scales from baseline to Week 4, as measured by the EORTC QLQ-C15-PAL.Timepoint: Baseline & 4 Weeks;Number of patients with adverse events like sedation, constipation and QTc prolongation will be represented as frequency or percentage Timepoint: Assessed weekly from baseline to Week 4	—

Measure

Time frame

Mean change in total daily oral morphine equivalent dose (mg) will be measured from baseline to Week 4.Timepoint: Baseline & at 4 weeks.;Change in global quality of life scores & symptom scales from baseline to Week 4, as measured by the EORTC QLQ-C15-PAL.Timepoint: Baseline & 4 Weeks;Number of patients with adverse events like sedation, constipation and QTc prolongation will be represented as frequency or percentage Timepoint: Assessed weekly from baseline to Week 4

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Countries

India

Contacts

Public ContactDr Raghu S Thota

Tata Memorial Hospital

hemlatakomti05@gmail.com9850146828

Outcome results

None listed

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