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Completed
NCT07192770
G-CSF-Related Bone Pain and Supportive Care Strategies in Patients With Solid Tumors
Conditions: Solid Tumors, Chemotherapy-induced Neutropenia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 190
Sponsor: Ankara Etlik City Hospital
Location: Etlik City Hospital Medical Oncology Department Ankara Yenimahalle
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.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Histologically or cytologically confirmed solid tumor
* Receiving systemic chemotherapy with primary or secondary filgrastim prophylaxis
* Eastern Cooperative Oncology Group performance status 0-3
* Written informed consent provided
Exclusion Criteria:
* Known bone metastases
* Active opioid use at enrollment
* Use of a nonsteroidal anti-inflammatory drug, opioid, or antihistamine within 2 days before enrollment, except for single doses administered before blood transfusion
* Cognitive or communication impairment preventing completion of study questionnaires
Source: ClinicalTrials.gov (NCT07192770). StuddyBuddy aggregates publicly available trial information.