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

NCT ID: NCT06265077

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-10-17

Brief Summary

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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

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Conditions

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Breast Cancer Filgrastim Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

famotidine and loratadine

Intervention Type DRUG

famotidine 20 mg once daily and loratadine 10 mg once daily

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Placebo

Placebo

Intervention Type DRUG

famotidine and loratadine

famotidine 20 mg once daily and loratadine 10 mg once daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Noha Mansour

OTHER

Sponsor Role lead

Responsible Party

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Noha Mansour

Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Mansoura University

Al Mansurah, Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2023-199

Identifier Type: -

Identifier Source: org_study_id