Clinical Trials Logo

Clinical Trial Summary

Methadone is an opioid that has been used for over 80 years to treat various types of pain, including cancer pain. Despite its increasing popularity as a co-analgesic and first-line treatment for cancer pain, there remain some outstanding questions regarding its use in treating cancer pain, such as its efficacy compared to other opioids and its appropriateness as a first-line treatment. The investigators will conduct a Vanguard Randomized Clinical Trial (RCT) to estimate the efficacy of methadone compared to morphine for the treatment of a newly defined type of cancer pain, which the investigators have termed 'adenocarcinopathic' pain (ACPP).


Clinical Trial Description

Background: Methadone is an opioid that has been used for over 80 years to treat various types of pain, including cancer pain. Its use as a co-analgesic and first-line treatment for cancer pain is becoming more widespread. Despite its increasing popularity, there remain some outstanding questions regarding its use in treating cancer pain, such as its efficacy compared to other opioids and its appropriateness as a first-line treatment. Traditional classifications of cancer related chronic pain is classified as neuropathic and nociceptive (somatic or visceral). This classification is based on clinical descriptors as opposed to pathophysiologic mechanisms. The investigators propose a new mechanism, called 'adenocarcinopathic' pain (ACPP), which can be defined as pain caused by an adenocarcinoma that is in 'proximity' to or invading a nerve or nerve plexus. The suggested mechanism of ACPP is that the tumour excretes excess glutamate, which activates NMDA receptors on nearby sensory nerves, causing the pain sensation. As methadone is an NMDA antagonist (and mu receptor agonist), it becomes an interesting molecule for ACPP in comparison to other opioids (such as morphine) that are unable to suppress NMDA receptors. Study Hypothesis: Methadone will demonstrate superior efficacy to morphine for the treatment of ACPP, and physicians will demonstrate satisfactory confidence in its use. Study Objectives: 1. Monitor safety and response to treatment 2. Evaluate the confidence of physicians Study Design: Participants will be randomized to receive either methadone or morphine. Patients will be observed for a period of 14 days, plus one physician follow-up after 28 days. Sample Size & Study Population: The investigators will aim to enrol n=40 patients total across all sites. Eligible outpatients are those for whom a strong opioid is being initiated or escalated for the treatment of ACPP. Intervention: For patients previously taking 0-30mg morphine equivalent daily dose (MEDD), starting dose is 0.5mg Q4H for methadone, 2.5mg for morphine. For those previously taking 31-60 mg MEDD, starting dose is 1.0mg Q4H for methadone, 5.0mg for morphine. Up to 4 breakthrough analgesia doses allowed per day. Dose escalations can be made at each patient encounter according to a standard dosing schedule. Study Outcome Measures: Using validated questionnaires, the patient's degree of pain control & relief, degree of satisfaction, global impression of change, and any side effects will be assessed. In addition, physicians will be asked to rate their confidence in treating each patient. Expected Outcomes: Positive results should provide justification to prolong the study to complete a phase III trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05325164
Study type Interventional
Source Ottawa Hospital Research Institute
Contact
Status Withdrawn
Phase Phase 3
Start date September 2022
Completion date September 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05678218 - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Recruiting NCT05161572 - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer Phase 2
Recruiting NCT02292641 - Beyond TME Origins N/A
Completed NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1
Recruiting NCT02125240 - Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma Phase 3
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Completed NCT02454647 - Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients N/A
Completed NCT01579721 - Prospective Randomized Study of SILS Versus CLS for Rectal Cancer Phase 4
Completed NCT01206530 - FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer Phase 1/Phase 2
Withdrawn NCT01148082 - School Response to Families Who Have Children With Cancer N/A
Completed NCT00548548 - A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer Phase 3
Completed NCT00377936 - EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Phase 2
Completed NCT00129844 - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer Phase 2
Completed NCT00183859 - Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan Phase 1
Recruiting NCT01930864 - Metformin Plus Irinotecan for Refractory Colorectal Cancer Phase 2
Completed NCT02498860 - Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung Phase 2
Terminated NCT01441128 - -02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer Phase 1
Active, not recruiting NCT04400474 - Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study Phase 2
Recruiting NCT02133196 - T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer Phase 2
Completed NCT02335151 - CTC Pancreatic Adenocarcinoma Phase 4