Status:
TERMINATED
Trial of Pregabalin for Granulocyte Colony-stimulating Factor (GCSF)-Induced Bone Pain
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Breast Cancer
Lymphoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Purpose: To evaluate the preventative effects of pregabalin on pegfilgrastim-induced bone pain in cycle 1. Because granulocyte colony stimulating factor (G-CSF) receptors are found at nerve endings w...
Detailed Description
\*\*Study Synopsis\*\* This is a randomized, double-blind, placebo-controlled, single center, crossover phase II clinical trial investigating the prophylactic analgesic effects of pregabalin (Lyrica®...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Diagnosis of a non-myeloid hematologic malignancy scheduled to initiate a cycle of chemotherapy that requires prophylactic use of a granulocyte colony-stimulating growth factor (based on the provider's discretion), provided the schedule of chemotherapy cycles allows the use of pegfilgrastim at a dose of 6 mg SC once per cycle OR Diagnosis of breast cancer scheduled to initiate dose-dense doxorubicin and cyclophosphamide (AC) chemotherapy or docetaxel and cyclophosphamide (TC) chemotherapy that requires prophylactic use of a granulocyte colony-stimulating growth factor, provided the schedule of chemotherapy cycles allows the use of pegfilgrastim, at a dose of 6 mg SC once per cycle; pegfilgrastim scheduled for 24 hours post chemotherapy.
- Schedule of chemotherapy and pegfilgrastim initiation can accommodate initiation of pregabalin 4 days prior to pegfilgrastim dose.
- Baseline pain scores \<7 as measured via 10-point numerical scale for pain (see section 11.1); pain score and use of any non-opioid pain medication must be self-reported as stable (same dose and frequency) over the 7 days prior to screening; for opioids, patient must self-report the same dose and frequency over the 28 days prior to screening. Patients who are receiving peri-procedural short-acting analgesics will still be included as long as they are no longer receiving analgesics by D1 of chemotherapy.
Exclusion
- A history of (within one month) or current pregabalin use.
- Baseline pain scores ≥7 as measured via 10-point numerical scale for pain (see section 11.1).
- Unwilling to discontinue use of antihistamines from 7 days prior to D1 of study medication.
- Creatinine clearance (CrCl) ≤60 ml/min (as measured via Cockcroft-Gault) based on serum creatinine measured as part of standard of care prior to administration of chemotherapy
- Women of childbearing potential must have a negative serum pregnancy test prior to initiating therapy (note, this test should be standard of care prior to administration of chemotherapy).
- Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator.
- Eligible and agrees to enroll into therapeutic trial ongoing at the Lineberger Comprehensive Cancer Center (LCCC) (i.e., the treatment trial will take precedence over LCCC1314).
- Currently receiving therapeutic doses of anticoagulants (ie, prophylactic use of anticoagulants is allowed) due to possibility of dizziness and falls while on pregabalin.
- Currently receiving aromatase inhibitors or agents targeted against Ph+ leukemias (i.e., imatinib, dasatinib, nilotinib, and ponatinib) or scheduled to start these drugs during cycle 1 of scheduled chemotherapy.
- Presence of bone metastases.
- History of angioedema.
- History of a seizure disorder.
Key Trial Info
Start Date :
January 27 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03407430
Start Date
January 27 2016
End Date
July 20 2017
Last Update
June 26 2018
Active Locations (1)
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1
North Carolina Cancer Hospital
Chapel Hill, North Carolina, United States, 27514