Clinical trial NCT02392039: Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma
Official title: Randomized, Placebo Controlled Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma
Conditions: Lymphoma
Summary: The goal of this clinical research study is to learn if loratadine can control bone pain caused by pegfilgrastim (a drug given after chemotherapy to help raise white blood cell counts).
Interventions:
description: 6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.
name: Pegfilgrastim
other_name: Neulasta
PEG-G-CSF
type: Drug
description: 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.<br/>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.
name: Loratadine
type: Drug
description: 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.<br/>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.
name: Placebo
other_name: Sugar Pill
type: Other
description: 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.
name: Questionnaires
other_name: Surveys
type: Behavioral
Study arms:
design_group_description: Pegfilgrastim 6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.<br/>Cycle 1 and 3:<br/>Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.<br/>Cycle 2 and 4:<br/>Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.<br/>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.
design_group_title: Group 1 - Loratadine
design_group_type: Experimental
design_group_description: Pegfilgrastim 6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.<br/>Cycle 1 and 3:<br/>Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.<br/>Cycle 2 and 4:<br/>Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.<br/>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.
design_group_title: Group 2 - Placebo
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: Amgen, Inc.
Drug name mappings:
name: 氯雷他定
lang: CN
name: Loratadine
lang: EN
name: ロラタジン
lang: JP