CompletedPhase 1/2

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

Egypt58 participantsStarted 2024-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Eligible patients were 18 years or older.
✓. Confirmed diagnosis of breast cancer.
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.

Exclusion criteria

✕. Patients with signs and symptoms of grade 2 or 3 bone pain at baseline.
✕. Patients receiving famotidine in the previous 72 hours.
✕. Patient receiving any antihistaminic in the previous 72 hours.
✕. Hypersensitivity to famotidine or loratadine.
✕. Patient receiving opioid or adjuvant analgesic.

What they're measuring

The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events

Timeframe: two weeks

Trial details

NCT IDNCT06265077

SponsorNoha Mansour

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-17

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