Support Care Cancer (2018) 26:1323–1334 https://doi.org/10.1007/s00520-017-3959-2 ORIGINAL ARTICLE NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim 1 2 3 4 5 Jeffrey J. Kirshner & Maxwell C. McDonald III & Flavio Kruter & Andrew S. Guinigundo & Linda Vanni & 6 7 7 7,8 7 Cathy L. Maxwell & Maureen Reiner & Terry E. Upchurch & Jacob Garcia & Phuong Khanh Morrow Received: 20 March 2017 /Accepted: 3 November 2017 /Published online: 16 November 2017 The Author(s) 2017. This article is an open access publication Abstract pain. The primary endpoint was all-grade bone pain in Purpose Mild-to-moderate bone pain is a commonly reported cycle 1 from AE reporting. Secondary endpoints included adverse event (AE) associated with pegfilgrastim. We evalu- bone pain in cycles 2–4 and across all cycles from AE ated the effect of prophylactic naproxen or loratadine vs no reporting and patient-reported bone pain by cycle and prophylactic treatment on pegfilgrastim-associated bone pain. across all cycles. Methods In this open-label study (NCT01712009), wom- Results Six hundred patients were enrolled. Most patients en ≥ 18
Supportive Care in Cancer – Springer Journals
Published: Nov 16, 2017
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