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Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain

NCT00930332 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-02-12

No results posted yet for this study

Summary

RATIONALE: Methadone hydrochloride may reduce chronic neuropathic pain in patients with cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of methadone hydrochloride as first-line therapy in treating patients with chronic neuropathic cancer pain.

Conditions

  • Nausea and Vomiting
  • Pain
  • Sleep Disorders
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

methadone hydrochloride

Level 1: 1 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA\*\* per day) Level 2: 2 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day) Level 3: 3mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day) OR Level 1: 2 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day) Level 2: 3 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day) Level 3: 4 mg q8h, breakthrough 1 mg q2h\* (maximum 6 BTA per day)

OTHER

questionnaire administration

within 48 hours of registration

PROCEDURE

management of therapy complications

if required

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Bruno Gagnon, MD, MSC · McGill Cancer Centre at McGill University

  • Ray Viola · Queen's University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-17
Primary Completion
2012-01-06
Completion
2012-01-06

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00930332 on ClinicalTrials.gov