Clinical trial · Interventional
Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia
- 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)
Paclitaxel is chemotherapeutic agent used in many of the most common anti-cancer regimens. Its use is frequently associated with moderate to severe muscle and joint pain that may persist for several days after the treatment. This side effect, known as "Arthralgia-Myalgia Syndrome, has a significant impact on the quality of life and functional abilities of those receiving the treatment, and is not alleviated by many of the interventions attempted for that purpose. Sporadic reports suggest that a drug called gabapentin may be effective in the management of this adverse effect. Observations from our practice indicate that pregabalin, which possesses similar biological activity to that of gabapentin, may also be useful in preventing and treating paclitaxel associated myalgia - arthralgia. The current study represents an initial evaluation of the hypothesis that pregabalin may be beneficial in the management of the symptoms due to the "Arthralgia-Myalgia Syndrome". The investigation will be carried out in the format of a small scale, randomized, placebo controlled trial with patients receiving paclitaxel in the course of standard treatment for breast cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Drug-related Side Effects and Adverse Reactions | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Taxane | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Pregabalin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pregabalin
- description
- Includes 19 out of 38 subjects reporting athralgia-myalgia in the wake of paclitaxel infusion in the course of breast cancer treatment. Pregabalin started on the evening before receiving infusion of paclitaxel and 5 day thereafter. Initial dosing of 75mg twice daily (morning + evening). Option for dose increase with additional 75mg in case of inadequate pain control. A minimal interval of 2 hours is required between doses. In case of poorly tolerated side effects a reduction to 50mg doses is available. Access to additional analgesic interventions is open as required for patient wellbeing.
- interventionNames
- Drug: Pregabalin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Includes 19 out of 38 subjects reporting athralgia-myalgia in the wake of paclitaxel infusion in the course of breast cancer treatment. Placebo externally identical to the pregabalin 75mg capsules will be started on the evening before receiving infusion of paclitaxel and 5 day thereafter. Initial dosing of 1 capsule twice daily (morning + evening). Option for dose increase with additional capsule in case of inadequate pain control. A minimal interval of 2 hours is required between doses. In case of poorly tolerated side effects a reduction to capsules with the appearance of 50mg pregabalin capsules is available. Access to additional analgesic interventions is open as required for patient wellbeing.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Screening Criteria: * Signature of consent form. * Legal competence for expression of consent. * Patients with confirmed diagnosis of cancer of breast, free of confounding pain before the administration of chemotherapy. * Recommendation for treatment with paclitaxel containing protocols, prior to initiation of chemotherapy. * Age over 18. Inclusion criteria for treatment phase: * Fulfillment of screening criteria. * Experience of myalgia-arthralgia related pain of moderate or worse degree of severity after a course of paclitaxel containing chemotherapy. Exclusion Criteria: * Ongoing treatment with pregabalin or gabapentin. * Known restricting adverse events related to treatment with pregabalin or gabapentin. * Renal failure with GFR less than 30ml/min. * Participation in clinical trial 3 weeks or less prior to screening. * Confounding myalgia and / or arthralgia unrelated to chemotherapy. * Medical condition compromising the likelihood of completing the trial.
References
Publications (14)
- BACKGROUNDBryans JS, Wustrow DJ. 3-substituted GABA analogs with central nervous system activity: a review. Med Res Rev. 1999 Mar;19(2):149-77. doi: 10.1002/(sici)1098-1128(199903)19:23.0.co;2-b. PMID 10189176
- BACKGROUNDCella D, Peterman A, Hudgens S, Webster K, Socinski MA. Measuring the side effects of taxane therapy in oncology: the functional assesment of cancer therapy-taxane (FACT-taxane). Cancer. 2003 Aug 15;98(4):822-31. doi: 10.1002/cncr.11578. PMID 12910528
- BACKGROUNDFarrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining the clinically important difference in pain outcome measures. Pain. 2000 Dec 1;88(3):287-294. doi: 10.1016/S0304-3959(00)00339-0. PMID 11068116
- BACKGROUNDForsyth PA, Balmaceda C, Peterson K, Seidman AD, Brasher P, DeAngelis LM. Prospective study of paclitaxel-induced peripheral neuropathy with quantitative sensory testing. J Neurooncol. 1997 Oct;35(1):47-53. doi: 10.1023/a:1005805907311. PMID 9266440
- BACKGROUNDGajraj NM. Pregabalin for pain management. Pain Pract. 2005 Jun;5(2):95-102. doi: 10.1111/j.1533-2500.2005.05205.x. PMID 17177755
- BACKGROUNDGajraj NM. Pregabalin: its pharmacology and use in pain management. Anesth Analg. 2007 Dec;105(6):1805-15. doi: 10.1213/01.ane.0000287643.13410.5e. PMID 18042886
- BACKGROUNDGarrison JA, McCune JS, Livingston RB, Linden HM, Gralow JR, Ellis GK, West HL. Myalgias and arthralgias associated with paclitaxel. Oncology (Williston Park). 2003 Feb;17(2):271-7; discussion 281-2, 286-8. PMID 12632867
- BACKGROUNDHarmark L, van Puijenbroek E, Straus S, van Grootheest K. Intensive monitoring of pregabalin: results from an observational, Web-based, prospective cohort study in the Netherlands using patients as a source of information. Drug Saf. 2011 Mar 1;34(3):221-31. doi: 10.2165/11585030-000000000-00000.