Clinical trial · Interventional
Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cancer pain is one of the most common and problematic symptoms. Opioids are typically the most common drugs used in the treatment of cancer pain,they are limited due to their side effects. Tramadol is a centrally acting non-opiate analgesic with low affinity for μ-opioid receptors, and is effective in the treatment of moderate to severe pain. Neuropathic pain is typically not amenable to standard opiate therapy, and the addition of tricyclic antidepressants or/and antiepileptic drugs can offer a very effective treatment strategy in such patients. Duloxetine is a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) that has been used traditionally for its antidepressant qualities and has also analgesic benefit in the treatment of neuropathic pain. Duloxetine exerts its analgesic action through central and peripheral pain modulation .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duloxetine 30 mg | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Tramadol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- •tramadol and duloxetine
- description
- patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive duloxetine 30mg daily fixed dose in combination with tramadol. Investigators will follow up the patients for 3 months
- interventionNames
- Drug: Duloxetine 30 mg
- Drug: Tramadol
- type
- ACTIVE_COMPARATOR
- label
- tramadol and placebo
- description
- patients will receive tramadol 50 mg twice daily, titration will be done every 3days until 2 weeks, maximum dose will be 400mg daily and will receive placebo drug once daily in combination with tramadol. Investigators will follow up the patients for 3 months
- interventionNames
- Drug: Tramadol
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with cancer pain 1. age from 20-70 years old. 2. not receiving any type of analgesia before (opioid naïve, no adjuvants). Exclusion Criteria: 1. Difficult to be assessed for pain. 2. Any contraindication for duloxetine or tramadol.
References
Publications (30)
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- BACKGROUNDAshby MA, Fleming BG, Brooksbank M, Rounsefell B, Runciman WB, Jackson K, Muirden N, Smith M. Description of a mechanistic approach to pain management in advanced cancer. Preliminary report. Pain. 1992 Nov;51(2):153-161. doi: 10.1016/0304-3959(92)90256-B. PMID 1283009
- BACKGROUNDKnudsen AK, Aass N, Fainsinger R, Caraceni A, Klepstad P, Jordhoy M, Hjermstad MJ, Kaasa S. Classification of pain in cancer patients--a systematic literature review. Palliat Med. 2009 Jun;23(4):295-308. doi: 10.1177/0269216309103125. Epub 2009 Mar 13. PMID 19286741
- BACKGROUND. World Health Organization. Cancer Pain Relief. 2. Geneva: WHO; 1996. 7.
- BACKGROUNDGutstein HB, Akil H. Opioid analgesics. In: Hardman JG, Limbrid E, editors. Goodman and Gilman's the Pharmacological Basis of Therapeutics. 10. New York: McGraw-Hill Professional; 2001. pp. 569-619.
- BACKGROUNDAlvarez V, Arttamangkul S, Williams JT. A RAVE about opioid withdrawal. Neuron. 2001 Dec 6;32(5):761-3. doi: 10.1016/s0896-6273(01)00530-x. PMID 11738021
- BACKGROUNDRaffa RB, Friderichs E, Reimann W, Shank RP, Codd EE, Vaught JL. Opioid and nonopioid components independently contribute to the mechanism of action of tramadol, an 'atypical' opioid analgesic. J Pharmacol Exp Ther. 1992 Jan;260(1):275-85.