Clinical trial · Observational
G-CSF-Induced Bone Pain and Supportive Care Approaches
Prospective Observational Evaluation of Supportive Care Strategies for G-CSF-Induced Bone Pain and Associated Symptoms in Patients With Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Neutropenia | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granulocyte colony-stimulating factor (G-CSF) | Biological | — | UNRESOLVED |
| Supportive Care (Analgesic and Non-Pharmacological Strategies) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients Receiving G-CSF During Chemotherapy
- description
- Adult patients (aged 18-70 years) with histologically or cytologically confirmed solid tumors who are receiving chemotherapy with prophylactic G-CSF (granulocyte colony-stimulating factor). Patients are consecutively enrolled and assessed for bone pain and supportive care needs before and one week after G-CSF administration.
- interventionNames
- Biological: Granulocyte colony-stimulating factor (G-CSF)
- Other: Supportive Care (Analgesic and Non-Pharmacological Strategies)
Primary outcomes (1)
- measure
- Change in Visual Analog Scale (VAS) Bone Pain Score (0-10)
- timeFrame
- Baseline and 1 week after G-CSF administration
- description
- Patient-reported bone pain intensity using the Visual Analog Scale (VAS, range 0-10; 0 = no pain, 10 = worst pain). A ≥20% reduction in score is considered a clinically meaningful improvement.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available