loratadine and Breast Neoplasms

loratadine has been researched along with Breast Neoplasms in 3 studies

Loratadine: A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.
loratadine : A benzocycloheptapyridine that is 6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine substituted by a chloro group at position 8 and a 1-(ethoxycarbonyl)piperidin-4-ylidene group at position 11. It is a H1-receptor antagonist commonly employed in the treatment of allergic disorders.

Breast Neoplasms: Tumors or cancer of the human BREAST.

Research

Studies (3)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Percentage of Participants With Bone Pain (All Grades) in Cycle 1

Bone pain data were captured as part of standard adverse event (AE) reporting. (NCT01712009)
Timeframe: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)

Area Under the Curve (AUC) for Patient-reported Bone Pain

Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)

Maximum Patient-reported Bone Pain by Cycle and Across Cycles

Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant's bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)

Mean Patient-reported Bone Pain by Cycle and Across Cycles

Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant's bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)

Number of Participants With Adverse Events (AEs)

"Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.~The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies." (NCT01712009)
Timeframe: From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.

Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles

Bone pain data were captured as part of standard adverse event (AE) reporting. (NCT01712009)
Timeframe: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)

Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles

Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling. (NCT01712009)
Timeframe: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)

Trials

1 trial available for loratadine and Breast Neoplasms

Other Studies

2 other studies available for loratadine and Breast Neoplasms