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

NCT ID: NCT00525967

Last Updated: 2007-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-10-31

Brief Summary

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The purpose of this study is to determine whether oral methadone plus acetaminophen can substitute morphine in the treatment of cancer pain.

Detailed Description

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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.

Conditions

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Cancer Pain Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Methadone plus Placebo

Group Type ACTIVE_COMPARATOR

Methadone plus Acetaminophen or Placebo

Intervention Type DRUG

Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid

2

Methadone plus Acetaminophen

Group Type EXPERIMENTAL

Methadone plus Acetaminophen or Placebo

Intervention Type DRUG

Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid

Interventions

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Methadone plus Acetaminophen or Placebo

Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Medicina do ABC

OTHER

Sponsor Role lead

Principal Investigators

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Daniel IG Cubero

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina do ABC

Auro del Giglio

Role: STUDY_DIRECTOR

Faculdade de Medicina do ABC

Locations

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Disciplina de Oncologia, Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Daniel IG Cubero, MD

Role: CONTACT

[email protected]
55-11-81799103

Facility Contacts

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Auro del Giglio, Professor

Role: primary

[email protected]
55-11-49935491

References

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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.

Reference Type RESULT
PMID: 9779694 (View on PubMed)

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.

Reference Type RESULT
PMID: 11387363 (View on PubMed)

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.

Reference Type RESULT
PMID: 10506634 (View on PubMed)

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.

Reference Type RESULT
PMID: 16051965 (View on PubMed)

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.

Reference Type RESULT
PMID: 14701781 (View on PubMed)

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.

Reference Type RESULT
PMID: 15310785 (View on PubMed)

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.

Reference Type RESULT
PMID: 9817288 (View on PubMed)

Related Links

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http://www.palliativedrugs.com

Newsletter, March 2004

Other Identifiers

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217/2005

Identifier Type: -

Identifier Source: org_study_id