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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06265077
• Other study ID #: 2023-199
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: February 2024
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Placebo
Placebo
• famotidine and loratadine
famotidine 20 mg once daily and loratadine 10 mg once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Noha Mansour

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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