Taxane | Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia
Taxane research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Drug-related Side Effects and Adverse Reactions
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PregabalinSee arm description
Drug:PlaceboSee arm description
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PregabalinIncludes 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.
PlaceboIncludes 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.
Start Date: December 2013
Completed Date: May 2015
Phase: Phase 2
Primary Outcome: Integrated Numeric Pain Scores and Rescue Analgesic Medication Requirement as calculated by the method proposed by Silverman et al (Silverman, O'Connor et al. 1993).
Secondary Outcome: Numeric Pain Score (NPS)
Study sponsors, principal investigator, and references
Principal Investigator: Jonathan Grunfeld, M.D.
Lead Sponsor: Assaf-Harofeh Medical Center
Bryans JS, Wustrow DJ. 3-substituted GABA analogs with central nervous system activity: a review. Med Res Rev. 1999 Mar;19(2):149-77. Review.