Novel Preventive Approach Against Filgrastim-Induced Bone Pain in 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Filgrastim Adverse Reaction Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mansoura University

Al Mansurah, Province, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Placebo

Drug

Placebo

famotidine and loratadine

Drug

famotidine 20 mg once daily and loratadine 10 mg once daily

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Noha Mansour

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Feb 20, 2024
Registry last updated: Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed