Clinical trial · Interventional
Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients
Efficacy and Safety of Loratadine and Famotidine Combination on Preventing Filgrastim-Induced Bone Pain in Breast Cancer Patients
NCT06265077CI-TRIAL-00083702completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Filgrastim Adverse Reaction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| famotidine and loratadine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention
- 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.
- interventionNames
- Drug: famotidine and loratadine
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- (control group) patients who will receive placebo plus filgrastim.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.