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

Noha Mansour

Status and phase: Completed; Phase 2; Phase 1

Conditions: Filgrastim Adverse Reaction; Breast Cancer

Treatments: Drug: Placebo; Drug: famotidine and loratadine

Study type: Interventional

Funder types: Other

Identifiers

NCT06265077

2023-199

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

(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.

Treatment:

Drug: famotidine and loratadine

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo