Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients

Noha Mansour58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Breast Cancer Filgrastim Adverse Reaction

Interventions

PlaceboDRUG

Placebo

famotidine and loratadineDRUG

famotidine 20 mg once daily and loratadine 10 mg once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mansoura University

Al Mansurah, Province, Egypt

Outcomes

Primary Outcomes

The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events

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

Time frame: two weeks

Data from ClinicalTrials.gov

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