G-CSF-Induced Bone Pain and Supportive Care Approaches
NCT07192770
Summary
This prospective observational study aims to evaluate bone pain and related symptoms in patients with solid tumors receiving granulocyte colony-stimulating factor (G-CSF) during chemotherapy. A total of 128 patients will be enrolled at Ankara Etlik City Hospital. Pain severity will be assessed using the Visual Analog Scale (VAS), and supportive care strategies such as analgesics and non-pharmacological approaches will be documented. Patient-reported outcomes, including quality of life, fatigue, anxiety, depression, and sleep quality, will also be evaluated before and one week after G-CSF administration. The findings are expected to provide practical insights into the management of G-CSF-induced bone pain and improve supportive care practices.
Eligibility
Inclusion Criteria: * Age 18-70 years * Histologically or cytologically confirmed solid tumor * Receiving chemotherapy with prophylactic or secondary prophylactic G-CSF (filgrastim, pegfilgrastim, or lipegfilgrastim) * ECOG performance status 0-3 * Able to complete patient-reported outcome questionnaires (VAS, QLQ-C30, FACT-G, FACT-F, PHQ-9, GAD-7, BDI, PSQI) * Written informed consent provided Exclusion Criteria: * Known bone metastases (confounds bone pain assessment) * Use of NSAIDs, opioids, or antihistamines within 48 hours prior to G-CSF administration * Patients not indicated for G-CSF prophylaxis * Severe cognitive impairment or communication barrier preventing completion of questionnaires * Active concurrent malignancy requiring systemic therapy * Known hypersensitivity to G-CSF or supportive care medications * Investigator judgment that participation may compromise data integrity or patient safety * ECOG performance status 4
Conditions4
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NCT07192770