Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia
Taxane, Drug-related Side Effects and Adverse Reactions, Pain
About this trial
This is an interventional treatment trial for Taxane focused on measuring Pregabalin, Arthralgia Myalgia Syndrome, Paclitaxel, Pain management, Breast cancer
Eligibility Criteria
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.
Sites / Locations
- Assaf HaRofeh Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Pregabalin
Placebo
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.
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.