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

NCT06265077 | Completed Phase 1 DMC

• 1 other identifier: 2023-199
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Filgrastim Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

ACTIVE COMPARATOR

(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

Control

PLACEBO COMPARATOR

(control group) patients who will receive placebo plus filgrastim.

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Control

famotidine and loratadine DRUG

famotidine 20 mg once daily and loratadine 10 mg once daily

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients were 18 years or older.
• Confirmed diagnosis of breast cancer.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.

You may not qualify if:

• Patients with signs and symptoms of grade 2 or 3 bone pain at baseline.
• Patients receiving famotidine in the previous 72 hours.
• Patient receiving any antihistaminic in the previous 72 hours.
• Hypersensitivity to famotidine or loratadine.
• Patient receiving opioid or adjuvant analgesic.

Sponsors & Collaborators

• Noha Mansour: lead

Study Sites (1)

Mansoura University

Al Mansurah, Province, 35516, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Famotidine; Loratadine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: February 20, 2024
• Study Start: February 1, 2024
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

EG (1)