Phase 2
Completed N=46
Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel
Source: ClinicalTrials.gov NCT01637077 ↗Enrolled (actual)
46
Serious AEs
4.7%
Results posted
Apr 2018
Primary outcomePrimary: Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score — 2.6; 3.2 units on a scale — p=0.56
Summary
This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score |
2.6; 3.2 | 0.56 |
| PRIMARY Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1). |
2.6; 2.2 | 0.48 |
| SECONDARY Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment. |
80.7; 82.6; 82.8; 86.8; 82.6; 91.3 | 0.62 |
| SECONDARY Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment |
2.2; 0 | — |
| SECONDARY The Percentage of Patients Who Use Non-prescription Pain Medications |
52.6; 50 | 0.87 |
| SECONDARY The Percentage of Patients Taking Opioid Medications |
15.8; 18.2 | 0.84 |
| SECONDARY The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel |
23.5; 59.1 | 0.03 sig |
| SECONDARY The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V) |
2.4; 4.7 | 0.12 |
| SECONDARY The Percentage of Patients Who Report, at Week's End, Using Non-prescription Pain Medications |
66.7; 60. | 0.78 |
| SECONDARY The Percentage of Patients Who Report, at Week's End, Using Opioids |
0; 26.7 | 0.16 |
| SECONDARY Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales |
88.4; 84.5; 88.4; 88.6; 92.0; 90.2 | 0.46 |
Eligibility Criteria
Inclusion Criteria
- Age > or equal to 18 years
- Ability to complete questionnaires by themselves or with assistance Paclitaxel at a dose of 80 mg/m^2 given, in the adjuvant setting, every week for a planned course of 12 weeks without any other concurrent therapy
- Paclitaxel at a dose of 80 mg/m2 given, in the adjuvant (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors).
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (per clinician discretion)
Exclusion Criteria
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
- Previous diagnosis of diabetic or other peripheral neuropathy
- Current, planned or previous use, within last 6 months, of gabapentin or pregabalin
- History of allergic or other adverse reactions to gabapentin or pregabalin
- Significant renal insufficiency with a history of a creatinine clearance (CrCL) < 30ml/min
- Prior exposure to neurotoxic chemotherapy
- Seizure history
- Diagnosis of fibromyalgia
- Previous exposure to paclitaxel
Data sourced from ClinicalTrials.gov (NCT01637077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.