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Trial Title:
Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients
NCT ID:
NCT06265077
Condition:
Breast Cancer
Filgrastim Adverse Reaction
Conditions: Official terms:
Breast Neoplasms
Loratadine
Famotidine
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Control
Intervention type:
Drug
Intervention name:
famotidine and loratadine
Description:
famotidine 20 mg once daily and loratadine 10 mg once daily
Arm group label:
Intervention
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
February 2024
Completion date:
August 2024
Lead sponsor:
Agency:
Noha Mansour
Agency class:
Other
Source:
Mansoura University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06265077
