Status:
RECRUITING
G-CSF-Induced Bone Pain and Supportive Care Approaches
Lead Sponsor:
Ankara Etlik City Hospital
Conditions:
Solid Tumors
Chemotherapy-induced Neutropenia
Eligibility:
All Genders
18-70 years
Brief 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 ...
Detailed Description
Granulocyte colony-stimulating factor (G-CSF) is widely used for primary or secondary prophylaxis of chemotherapy-induced neutropenia. Despite its clinical benefits, G-CSF frequently induces bone pain...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 15 2026
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT07192770
Start Date
September 27 2025
End Date
January 15 2026
Last Update
October 2 2025
Active Locations (1)
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1
Etlik City Hospital Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye), 06270