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

Phase 1

Completed

• Conditions: Breast Cancer; Filgrastim Adverse Reaction
• Interventions: Drug: famotidine and loratadine; Drug: Placebo

• Registration Number: NCT06265077
• Lead Sponsor: Noha Mansour

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-02-10
• Study First Submitted QC: 2024-02-10
• Study First Posted: 2024-02-20
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	famotidine and loratadine	(intervention group) patients who will receive filgrastim plus oral famotidine 20 mg once daily and loratadine 10 mg once daily for the full filgrastim treatment period.
Control	Placebo	(control group) patients who will receive placebo plus filgrastim.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Province, Egypt