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Browse 5,597 clinical trials for breast cancer. Find studies that match your criteria and connect with research centers.
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NCT03407430
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.
NCT00627978
Primary Objectives * Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy * Detailed characterization of peripheral neuropathy in patients who receive ixabepilone Secondary Objectives * Clinical benefit rate * Time to progression ( TTP) * Toxicity * Exploratory studies: * Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic changes observed in neurons. * Relation of NGF, IL8, and IL10 to the development of clinical symptoms and ultrastructural changes in neurons.