Methadone for 'Adenocarcinopathic' Pain Treatment
Summary
Methadone is an opioid that has been used for over 80 years to treat various types of pain, including cancer pain. Despite its increasing popularity as a co-analgesic and first-line treatment for cancer pain, there remain some outstanding questions regarding its use in treating cancer pain, such as its efficacy compared to other opioids and its appropriateness as a first-line treatment. The investigators will conduct a Vanguard Randomized Clinical Trial (RCT) to estimate the efficacy of methadone compared to morphine for the treatment of a newly defined type of cancer pain, which the investigators have termed 'adenocarcinopathic' pain (ACPP).
Timeline
- Start
- 2022-09
- Primary completion
- 2023-08
- Completion
- 2023-09
Outcome
Outcome not reported
Stopped: “Trial not started; change in Sponsor and Principal Investigator, trial to be registered again by new Sponsor/Investigator if it is started.”
Publications
- Background 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.
- Background Mercadante S, Bruera E. Methadone as a First-Line Opioid in Cancer Pain Management: A Systematic Review. J Pain Symptom Manage. 2018 Mar;55(3):998-1003. doi: 10.1016/j.jpainsymman.2017.10.017. Epub 2017 Nov 1.
- Background Haumann J, Geurts JW, van Kuijk SM, Kremer B, Joosten EA, van den Beuken-van Everdingen MH. Methadone is superior to fentanyl in treating neuropathic pain in patients with head-and-neck cancer. Eur J Cancer. 2016 Sep;65:121-9. doi: 10.1016/j.ejca.2016.06.025. Epub 2016 Aug 3.
- Background Leppert W, Zajaczkowska R, Wordliczek J, Dobrogowski J, Woron J, Krzakowski M. Pathophysiology and clinical characteristics of pain in most common locations in cancer patients. J Physiol Pharmacol. 2016 Dec;67(6):787-799.
- Background Slosky LM, BassiriRad NM, Symons AM, Thompson M, Doyle T, Forte BL, Staatz WD, Bui L, Neumann WL, Mantyh PW, Salvemini D, Largent-Milnes TM, Vanderah TW. The cystine/glutamate antiporter system xc- drives breast tumor cell glutamate release and cancer-induced bone pain. Pain. 2016 Nov;157(11):2605-2616. doi: 10.1097/j.pain.0000000000000681.
- Background Gagnon B, Almahrezi A, Schreier G. Methadone in the treatment of neuropathic pain. Pain Res Manag. 2003 Fall;8(3):149-54. doi: 10.1155/2003/236718.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methadone | Other / unclassified | 2.5 mg | Oral |
| Subject | Methadone | Other / unclassified | 3 mg | Oral |
| Comparator | Morphine | Other / unclassified | 12.5 mg | Oral |
| Comparator | Morphine | Other / unclassified | 15 mg | Oral |