NOLAN: Naproxen or Loratadine and Neulasta

Summary

The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.

Timeline

Start

2012-11-01

Primary completion

2015-03-18

Completion

2015-03-18

Outcome

Missed primary endpoint

registry analysis (superiority or other test); No Prophylaxis vs Naproxen 500 mg BID; Difference -6.3 (95% CI -16.7 to 4.1) NCT01712009 ↗

registry analysis (superiority or other test); No Prophylaxis vs Loratadine 10 mg QD; Difference -4.1 (95% CI -14.5 to 6.3) NCT01712009 ↗

registry analysis (superiority or other test); Naproxen 500 mg BID vs Loratadine 10 mg QD; Difference 2.2 (95% CI -8.0 to 12.4) NCT01712009 ↗

Publications

• Background Kirshner JJ, McDonald MC 3rd, Kruter F, Guinigundo AS, Vanni L, Maxwell CL, Reiner M, Upchurch TE, Garcia J, Morrow PK. 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. Support Care Cancer. 2018 Apr;26(4):1323-1334. doi: 10.1007/s00520-017-3959-2. Epub 2017 Nov 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Loratadine	Small molecule	10 mg	—
Subject	Naproxen	Small molecule	500 mg	Oral
Background	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous

Indications