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Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain

Primary Purpose

Cancer, Pain, Palliative Care

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Methadone plus Acetaminophen or Placebo
Sponsored by
Faculdade de Medicina do ABC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Cancer Pain, Methadone, Morphine, Acetaminophen, Palliative Care

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of cancer pain
  • Regular use of oral Morphine

Exclusion Criteria:

  • Use of Acetaminophen in the last 48 hours
  • Renal or Hepatic failure

Sites / Locations

  • Disciplina de Oncologia, Faculdade de Medicina do ABCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Methadone plus Placebo

Methadone plus Acetaminophen

Outcomes

Primary Outcome Measures

Pain intensity and time to equianalgesic effect

Secondary Outcome Measures

Degree of nausea, vomiting, obstipation, xerostomia and drowsiness

Full Information

First Posted
September 5, 2007
Last Updated
September 5, 2007
Sponsor
Faculdade de Medicina do ABC
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1. Study Identification

Unique Protocol Identification Number
NCT00525967
Brief Title
Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain
Official Title
Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain: A Randomized, Double-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Faculdade de Medicina do ABC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether oral methadone plus acetaminophen can substitute morphine in the treatment of cancer pain.
Detailed Description
Opioids are the mainstay of moderate-to-severe cancer pain management. Although morphine is the most commonly used, methadone has some advantages such as higher potency, lower cost and longer administration intervals. To minimize the time necessary to achieve the equianalgesic effect after a switching from morphine to methadone, acetaminophen was added in the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain, Palliative Care
Keywords
Cancer Pain, Methadone, Morphine, Acetaminophen, Palliative Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Methadone plus Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Methadone plus Acetaminophen
Intervention Type
Drug
Intervention Name(s)
Methadone plus Acetaminophen or Placebo
Intervention Description
Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid
Primary Outcome Measure Information:
Title
Pain intensity and time to equianalgesic effect
Time Frame
within the first 7 days after switching
Secondary Outcome Measure Information:
Title
Degree of nausea, vomiting, obstipation, xerostomia and drowsiness
Time Frame
within the first 7 days of switching

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of cancer pain Regular use of oral Morphine Exclusion Criteria: Use of Acetaminophen in the last 48 hours Renal or Hepatic failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel IG Cubero, MD
Phone
55-11-81799103
Email
danielcubero@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel IG Cubero
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Auro del Giglio
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Study Director
Facility Information:
Facility Name
Disciplina de Oncologia, Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Auro del Giglio, Professor
Phone
55-11-49935491
Email
sandrabr@netpoint.com.br
First Name & Middle Initial & Last Name & Degree
Daniel IG Cubero, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
9779694
Citation
Ripamonti C, Groff L, Brunelli C, Polastri D, Stavrakis A, De Conno F. Switching from morphine to oral methadone in treating cancer pain: what is the equianalgesic dose ratio? J Clin Oncol. 1998 Oct;16(10):3216-21. doi: 10.1200/JCO.1998.16.10.3216.
Results Reference
result
PubMed Identifier
11387363
Citation
Mercadante S, Casuccio A, Fulfaro F, Groff L, Boffi R, Villari P, Gebbia V, Ripamonti C. Switching from morphine to methadone to improve analgesia and tolerability in cancer patients: a prospective study. J Clin Oncol. 2001 Jun 1;19(11):2898-904. doi: 10.1200/JCO.2001.19.11.2898.
Results Reference
result
PubMed Identifier
10506634
Citation
Mercadante S, Casuccio A, Calderone L. Rapid switching from morphine to methadone in cancer patients with poor response to morphine. J Clin Oncol. 1999 Oct;17(10):3307-12. doi: 10.1200/JCO.1999.17.10.3307.
Results Reference
result
PubMed Identifier
16051965
Citation
Mercadante S, Ferrera P, Villari P, Casuccio A. Rapid switching between transdermal fentanyl and methadone in cancer patients. J Clin Oncol. 2005 Aug 1;23(22):5229-34. doi: 10.1200/JCO.2005.13.128.
Results Reference
result
PubMed Identifier
14701781
Citation
Bruera E, Palmer JL, Bosnjak S, Rico MA, Moyano J, Sweeney C, Strasser F, Willey J, Bertolino M, Mathias C, Spruyt O, Fisch MJ. Methadone versus morphine as a first-line strong opioid for cancer pain: a randomized, double-blind study. J Clin Oncol. 2004 Jan 1;22(1):185-92. doi: 10.1200/JCO.2004.03.172.
Results Reference
result
PubMed Identifier
15310785
Citation
Stockler M, Vardy J, Pillai A, Warr D. Acetaminophen (paracetamol) improves pain and well-being in people with advanced cancer already receiving a strong opioid regimen: a randomized, double-blind, placebo-controlled cross-over trial. J Clin Oncol. 2004 Aug 15;22(16):3389-94. doi: 10.1200/JCO.2004.09.122.
Results Reference
result
PubMed Identifier
9817288
Citation
Mercadante S, Casuccio A, Agnello A, Serretta R, Calderone L, Barresi L. Morphine versus methadone in the pain treatment of advanced-cancer patients followed up at home. J Clin Oncol. 1998 Nov;16(11):3656-61. doi: 10.1200/JCO.1998.16.11.3656.
Results Reference
result
Links:
URL
http://www.palliativedrugs.com
Description
Newsletter, March 2004

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Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain

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