1
Participants
Start Date
December 14, 2015
Primary Completion Date
April 4, 2018
Study Completion Date
April 4, 2018
Pegfilgrastim
6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.
Loratadine
"Group 1 - Cycles 1 and 3: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.~Group 2 - Cycle 2 and 4: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days."
Placebo
"Group 1 - Cycle 2 and 4: Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.~Group 2 - Cycle 1 and 3 : Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days."
Questionnaires
Three questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Amgen
INDUSTRY
M.D. Anderson Cancer Center
OTHER