Back to results

Methadone Associated With Morphine for Cancer Pain

Primary Purpose

Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Morphine

Methadone

About this trial

This is an interventional treatment trial for Cancer focused on measuring Morphine, Methadone, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Approved by the Ethics Committee
signed the informed consent
cancer pain
starting the WHO thirth analgesic ladder,

Exclusion Criteria:

cognitive impairment
psychiatric disease
illicit drug user
hypersensitivity to the study drugs
pregnant

Sites / Locations

Rioko K SakataRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Morphine- Methadone

Morphine

Arm Description

Morphine 5mg/6h plus metadone: 2,5mg/12h

Morphine: 5mg/6h

Outcomes

Primary Outcome Measures

Opioid consumption

Total dose of morphine used by the patient

Secondary Outcome Measures

Pain intensity

Measure of pain intensity by verbal numerical rating score (VNRS - zero to 10) where 0 is no pain and 10 is the worst pain imaginable. Values between 0 and 3 mean a good result, between 4 and 6 a poor result and between 7 and 10 a very poor result.

Full Information

NCT ID

NCT03324815

First Posted

October 25, 2017

Last Updated

October 26, 2017

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03324815

Brief Title

Methadone Associated With Morphine for Cancer Pain

Official Title

Analgesic Effect Evaluation of Methadone Associated With Morphine for Cancer Pain: Prospective Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 2, 2017 (Actual)

Primary Completion Date

July 30, 2018 (Anticipated)

Study Completion Date

August 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study was prospective, randomized. Patients with cancer pain were evaluated, one group receiving methadone with morphine and another group receiving morphine as the only opioid. Pain intensity, total morphine dose and adverse effects were evaluated.

Detailed Description

Opioids are the most important analgesics for the relief of cancer pain. In addition tolerance and hyperalgesia may ocurr as a consequence of treatment with these drugs. Medications for pain relief may also cause increased pain. NMDA receptor blockers may prevent or reduce the development of hyperalgesia. Methadone is a weak NMDA receptor antagonist and therefore its association could prevent hyperalgesia. The primary endpoint of the study was whether the administration of low dose methadone associated with morphine promotes better analgesic effect in patients with cancer pain, And secondarily to assess whether there is a reduction in the total dose of opioid needed for pain relief, and whether reduction of the opioid-related adverse effects occurs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer

Keywords

Morphine, Methadone, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Morphine- Methadone

Arm Type

Active Comparator

Arm Description

Morphine 5mg/6h plus metadone: 2,5mg/12h

Arm Title

Morphine

Arm Type

Active Comparator

Arm Description

Morphine: 5mg/6h

Intervention Type

Drug

Intervention Name(s)

Morphine

Other Intervention Name(s)

Dimorf

Intervention Description

Pain Treatment

Intervention Type

Drug

Intervention Name(s)

Methadone

Other Intervention Name(s)

Mytedom

Intervention Description

Pain Treatment

Primary Outcome Measure Information:

Title

Opioid consumption

Description

Total dose of morphine used by the patient

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Pain intensity

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Approved by the Ethics Committee signed the informed consent cancer pain starting the WHO thirth analgesic ladder, Exclusion Criteria: cognitive impairment psychiatric disease illicit drug user hypersensitivity to the study drugs pregnant

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Feliciano NC Duarte, MD

Phone

55 11 99265 7272

feliciano.contardo@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rioko K Sakata, MD; PhD

Organizational Affiliation

Universidade Federal de São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rioko K Sakata

City

São Paulo

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rioko K Sakata, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34265791

Citation

Duarte FCN, Ferraro LHDC, Ferreira A, Sakata RK. A Randomized Controlled Trial Evaluating the Analgesic Effect of the Combination of Methadone With Morphine for Cancer Related Pain. Clin J Pain. 2021 Sep 1;37(9):664-668. doi: 10.1097/AJP.0000000000000959.

Results Reference

derived

Learn more about this trial

Methadone Associated With Morphine for Cancer Pain

We'll reach out to this number within 24 hrs