Trial of Pregabalin for Granulocyte Colony-stimulating Factor (GCSF)-Induced Bone Pain
Status:
Terminated
Trial end date:
2017-07-20
Target enrollment:
Participant gender:
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 which modulate the pain signal, blocking this with pregabalin is theorized to prevent
the occurrence of this adverse effect.
Participants:
Patients will be at least 18 years of age with either a diagnosis of a non-myeloid
hematologic malignancy scheduled to initiate a cycle of chemotherapy that requires
prophylactic use of a G-CSF, or with a diagnosis of breast cancer scheduled to initiate
dose-dense doxorubicin/cyclophosphamide chemotherapy or docetaxel/cyclophosphamide that
requires prophylactic use of a G-CSF.
Procedures (methods):
This is a randomized (1:1), single center, placebo-controlled, double blind, crossover phase
II study. The primary objective is to compare the proportion of patients who have an increase
in pain score of ≥3 from baseline in cycle 1 between Arm A (pregabalin) and Arm B (placebo).
In consultation with the treating physician, the PI will determine what day pegfilgrastim
will be initiated in each eligible, consented patient. Pregabalin or placebo will begin 4
days prior to pegfilgrastim administration, and continue for 7 additional days starting the
day of pegfilgrastim administration.