Breast Cancer, Filgrastim Adverse Reaction
Conditions
Brief summary
No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain.
Interventions
DRUGPlacebo
Placebo
DRUGfamotidine and loratadine
famotidine 20 mg once daily and loratadine 10 mg once daily
Sponsors
Noha Mansour
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eligible patients were 18 years or older. 2. Confirmed diagnosis of breast cancer. 3. Patients completed adriamycin and cyclophosphamide (AC) regimen and are planned to receive four cycles or more of paclitaxel chemotherapy with G-CSF support starting in cycle 1 and continuing throughout each of the four paclitaxel cycles. 4. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
Exclusion criteria
1. Patients with signs and symptoms of grade 2 or 3 bone pain at baseline. 2. Patients receiving famotidine in the previous 72 hours. 3. Patient receiving any antihistaminic in the previous 72 hours. 4. Hypersensitivity to famotidine or loratadine. 5. Patient receiving opioid or adjuvant analgesic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events | two weeks | Difference between the two arms regarding the incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events |
Countries
Egypt
Outcome results
None listed