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CompletedNCT06265077Updated Dec 13, 2024

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

A Phase 1/2 interventional study of Placebo and famotidine and loratadine in Breast Cancer and Filgrastim Adverse Reaction, sponsored by Noha Mansour. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.

Sponsored by Noha Mansour · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Filgrastim Adverse Reaction

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03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 58 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

Noha Mansour is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
58 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Control

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

    Drug: Placebo

Interventions

  • DrugPlacebo

    Placebo

  • Drugfamotidine and loratadine

    Drug pages: Famotidine · Loratadine

    famotidine 20 mg once daily and loratadine 10 mg once daily

06

What researchers measure

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

    Time frame: two weeks

07

Study locations

1 site
  • Mansoura University
    Al Mansurah, Province 35516, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06265077
Lead sponsor
Noha Mansour
Responsible party
Noha Mansour (Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department, Mansoura University) — Sponsor-investigator
First posted
Feb 20, 2024
Start date
Feb 1, 2024
Primary completion
Oct 17, 2024
Completion
Oct 17, 2024
Last update
Dec 13, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Famotidine · Loratadine

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