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

Efficacy and Safety of Loratadine and Famotidine Combination on Preventing Filgrastim-Induced Bone Pain in Breast Cancer Patients

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 Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Filgrastim Adverse Reaction
• Intervention / Treatment: Drug: Placebo; Drug: famotidine and loratadine

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; (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.	Drug: famotidine and loratadine; famotidine 20 mg once daily and loratadine 10 mg once daily
Placebo Comparator: Control; (control group) patients who will receive placebo plus filgrastim.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	two weeks

Collaborators and Investigators

• Sponsor: Noha Mansour

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 10, 2024
• First Submitted That Met QC Criteria: February 10, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Dermatologic Agents; Anti-Ulcer Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Histamine H2 Antagonists; Famotidine; Loratadine
• Other Study ID Numbers: 2023-199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No