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COMPLETED
NCT07192770

G-CSF-Related Bone Pain and Supportive Care Strategies in Patients With Solid Tumors

Sponsor: Ankara Etlik City Hospital

View on ClinicalTrials.gov

Summary

This prospective two-center observational cohort study evaluated G-CSF-related bone pain and multidimensional symptom burden in adults with solid tumors receiving chemotherapy and filgrastim prophylaxis. Participants received one of two physician-selected supportive-care strategies as part of routine clinical practice: naproxen alone or naproxen plus loratadine. Pain was assessed using an 11-point Numeric Rating Scale (NRS) at baseline and on study day 8, with study day 1 defined as the first day of filgrastim administration. Patient-reported outcomes included the EORTC QLQ-C30, GAD-7, Beck Depression Inventory, and Pittsburgh Sleep Quality Index. A total of 190 patients were enrolled at Ankara Etlik City Hospital and Gazi University Faculty of Medicine.

Official title: Bone Pain and Multidimensional Symptom Burden Following G-CSF Prophylaxis in Patients With Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

190

Start Date

2025-09-27

Completion Date

2026-02-19

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

Filgrastim (G-CSF)

Filgrastim was administered as part of routine clinical care beginning at least 24 hours after completion of chemotherapy and continued once daily for 5 consecutive days. Patients weighing 60 kg or less received 300 micrograms daily, whereas patients weighing more than 60 kg received 480 micrograms daily.

DRUG

Naproxen

Naproxen 500 mg was administered orally once daily for 5 days, beginning on the first day of filgrastim administration, as part of physician-selected routine supportive care.

DRUG

Loratadine

Loratadine 10 mg was administered orally once daily for 5 days, beginning on the first day of filgrastim administration, together with naproxen as part of physician-selected routine supportive care.

Locations (2)

Etlik City Hospital Medical Oncology Department

Ankara, Yenimahalle, Turkey (Türkiye)

Gazi University, Medical Oncology Department

Ankara, Çankaya, Turkey (Türkiye)