PMID- 21775131 OWN - NLM STAT- MEDLINE DCOM- 20111205 LR - 20131121 IS - 1879-0852 (Electronic) IS - 0959-8049 (Linking) VI - 47 IP - 16 DP - 2011 Nov TI - How to switch from morphine or oxycodone to methadone in cancer patients? a randomised clinical phase II trial. PG - 2463-70 LID - 10.1016/j.ejca.2011.06.047 [doi] AB - AIM: Opioid switching is a treatment strategy in cancer patients with unacceptable pain and/or adverse effects (AEs). We investigated whether patients switched to methadone by the stop and go (SAG) strategy have lower pain intensity (PI) than the patients switched over three days (3DS), and whether the SAG strategy is as safe as the 3DS strategy. METHODS: In this prospective, open, parallel-group, multicentre study, 42 cancer patients on morphine or oxycodone were randomised to the SAG or 3DS switching-strategy to methadone. The methadone dose was calculated using a dose-dependent ratio. PI, AEs and serious adverse events (SAEs) were recorded daily for 14 days. Primary outcome was average PI day 3. Secondary outcomes were PI now and AEs day 3 and 14 and number of SAEs. RESULTS: Twenty one patients were randomised to each group, 16 (SAG) and 19 (3DS) patients received methadone. The mean preswitch morphine doses were 900 mg/day in SAG and 1330 mg/day in 3DS. No differences between groups were found in mean average PI day 3 (mean difference 0.5 (CI -1.2-2.2); SAG 4.1 (CI 2.3-5.9) and 3DS 3.6 (CI 2.9-4.3) or in PI now. The SAG group had more dropouts and three SAEs (two deaths and one severe sedation). No SAEs were observed in the 3DS group. CONCLUSION: The SAG patients reported a trend of more pain, had significantly more dropouts and three SAEs, which indicate that the SAG strategy should not replace the 3DS when switching from high doses of morphine or oxycodone to methadone. CI - Copyright (c) 2011 Elsevier Ltd. All rights reserved. FAU - Moksnes, K AU - Moksnes K AD - Pain and Palliation Research Group, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. kristin.moksnes@ntnu.no FAU - Dale, O AU - Dale O FAU - Rosland, J H AU - Rosland JH FAU - Paulsen, O AU - Paulsen O FAU - Klepstad, P AU - Klepstad P FAU - Kaasa, S AU - Kaasa S LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110719 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 0 (Analgesics, Opioid) RN - 76I7G6D29C (Morphine) RN - CD35PMG570 (Oxycodone) RN - UC6VBE7V1Z (Methadone) SB - IM CIN - Eur J Cancer. 2012 Apr;48(6):944-5; author reply 946-7. PMID: 22305512 MH - Administration, Oral MH - Aged MH - Aged, 80 and over MH - Analgesics, Opioid/*administration & dosage/adverse effects MH - Dose-Response Relationship, Drug MH - Drug Substitution/*methods MH - Female MH - Humans MH - Male MH - Methadone/*administration & dosage/adverse effects MH - Middle Aged MH - Morphine/*administration & dosage/adverse effects MH - Neoplasms/*complications MH - Oxycodone/*administration & dosage/adverse effects MH - Pain/*drug therapy/etiology MH - Patient Dropouts MH - Prospective Studies EDAT- 2011/07/22 06:00 MHDA- 2011/12/13 00:00 CRDT- 2011/07/22 06:00 PHST- 2011/05/03 00:00 [received] PHST- 2011/06/20 00:00 [accepted] PHST- 2011/07/22 06:00 [entrez] PHST- 2011/07/22 06:00 [pubmed] PHST- 2011/12/13 00:00 [medline] AID - S0959-8049(11)00475-8 [pii] AID - 10.1016/j.ejca.2011.06.047 [doi] PST - ppublish SO - Eur J Cancer. 2011 Nov;47(16):2463-70. doi: 10.1016/j.ejca.2011.06.047. Epub 2011 Jul 19.