Clinical trial NCT00525967: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cancer
Pain
Palliative Care
Keywords: Cancer Pain
Methadone
Morphine
Acetaminophen
Palliative Care
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2007-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain intensity and time to equianalgesic effect
timeFrame: within the first 7 days after switching
Secondary outcomes:
measure: Degree of nausea, vomiting, obstipation, xerostomia and drowsiness
timeFrame: within the first 7 days of switching
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Disciplina de Oncologia, Faculdade de Medicina do ABC
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Daniel IG Cubero
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Medicina do ABC
name: Auro del Giglio
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.