An observational study in Solid Tumors and Chemotherapy-induced Neutropenia, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Ankara Etlik City Hospital · Observational
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.
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, which negatively affects treatment adherence, quality of life, and overall patient comfort. This prospective observational study is designed to systematically evaluate bone pain, quality of life, functional status, mood, and sleep quality in patients with solid tumors receiving G-CSF. A total of 128 participants will be consecutively enrolled at Ankara Etlik City Hospital.
Study Cohort:
All enrolled patients will be adults (aged 18-70 years) with histologically or cytologically confirmed solid tumors receiving chemotherapy with prophylactic G-CSF (filgrastim, pegfilgrastim, or lipegfilgrastim). Participants will be consecutively recruited and assessed for bone pain and supportive care needs before and one week after G-CSF administration. If different G-CSF agents are used, subgroup analyses will be performed according to the type of G-CSF received.
Study Design and Visits:
Eligible patients will be assessed at baseline (before G-CSF administration) and one week after G-CSF. Data will include demographic and clinical characteristics, treatment details, laboratory parameters, and patient-reported outcomes. Pain intensity will be measured using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst possible pain). A ≥20% reduction will be considered a clinically meaningful improvement.
Patient-Reported Outcomes and Validation:
EORTC QLQ-C30 (Quality of Life Questionnaire-Core 30): Validated in Turkish cancer populations. Scores range from 0-100; higher functional and global health scores indicate better outcomes, whereas higher symptom scores reflect greater symptom burden.
FACT-G (Functional Assessment of Cancer Therapy-General): Turkish validation is available. Scores range from 0-108; higher scores indicate better overall quality of life.
FACT-F (Fatigue Subscale): Part of the FACT measurement system, validated in Turkish cancer patients. Scores range from 0-52; higher scores indicate lower fatigue severity.
PHQ-9 (Patient Health Questionnaire-9): Turkish validation established. Scores range from 0-27. Cut-offs: 5-9 mild, 10-14 moderate, 15-19 moderately severe, ≥20 severe depression.
GAD-7 (Generalized Anxiety Disorder-7): Validated in Turkish. Scores range from 0-21. Cut-offs: 5 mild, 10 moderate, ≥15 severe anxiety.
Beck Depression Inventory (BDI): Validated Turkish version used. Scores range 0-63. Cut-offs: 0-9 minimal, 10-18 mild, 19-29 moderate, 30-63 severe depression.
PSQI (Pittsburgh Sleep Quality Index): Turkish validation established. Global scores range from 0-21; scores >5 indicate poor sleep quality.
Study Outcomes:
The primary outcome is the change in VAS bone pain scores from baseline to one week after G-CSF administration. Secondary outcomes include changes in QLQ-C30, FACT-G, FACT-F, PHQ-9, GAD-7, BDI, and PSQI scores. Analgesic use and correlations between demographic/clinical features (age, ECOG status, tumor type) and supportive care strategies will also be explored.
Significance:
This study is expected to generate real-world evidence on the prevalence, severity, and management of G-CSF-induced bone pain in patients with solid tumors. Incorporating validated patient-reported outcome tools with established cut-offs ensures methodological rigor and facilitates cross-study comparability. Results may guide clinicians in selecting effective supportive interventions, reduce symptom burden, and improve adherence to chemotherapy.
1,863 studies on the registry are indexed under Fatigue; 377 are open to participants now.
This study's enrollment of 225 is above the median of 100 across 367 observational studies indexed under Fatigue.
Browse Fatigue studies →Ankara Etlik City Hospital is the lead sponsor of 167 studies on the registry; 74 are open to participants now.
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Adult male and female patients (aged 18-70 years) with histologically or cytologically confirmed solid tumors, receiving chemotherapy and prophylactic G-CSF at Ankara Etlik City Hospital. Participants will be consecutively recruited, without randomization, as part of routine clinical care. The study population represents a real-world oncology cohort, designed to capture the prevalence, severity, and management of G-CSF-induced bone pain and related quality-of-life outcomes.
Exclusion Criteria:
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.
Biological: Granulocyte colony-stimulating factor (G-CSF) · Other: Supportive Care (Analgesic and Non-Pharmacological Strategies)
Patients receive chemotherapy with prophylactic G-CSF (granulocyte colony-stimulating factor) as part of routine clinical care. Both short-acting (filgrastim) and long-acting formulations (pegfilgrastim, lipegfilgrastim) may be used according to standard oncology practice. The study does not assign the intervention but observes supportive care strategies and patient-reported outcomes related to G-CSF-induced bone pain.
Also known as: Lipegfilgrastim, Filgrastim, Pegfilgrastim
Supportive care strategies including analgesic use (NSAIDs, opioids, antihistamines) and non-pharmacological interventions (rest, exercise, local heat/cold, relaxation techniques) will be recorded as part of routine practice. The study does not randomize or assign supportive care but documents their use and association with bone pain outcomes.
Also known as: Non-drug supportive measures, Analgesics
Change in Visual Analog Scale (VAS) Bone Pain Score (0-10)
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.
Time frame: Baseline and 1 week after G-CSF administration
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health/Quality of Life Score (0-100)
Change in global health status/quality of life score from the EORTC QLQ-C30 (0-100 scale). Higher scores indicate better quality of life. Turkish validation available.
Time frame: Baseline and 1 week after G-CSF administration
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score (0-108)
Change in FACT-G total score (0-108). Higher scores indicate better overall quality of life. Turkish validation available.
Time frame: Baseline and 1 week after G-CSF administration
Change in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) Subscale Score (0-52)
Change in FACT-F subscale score (0-52). Higher scores indicate less fatigue. Turkish validation available.
Time frame: Baseline and 1 week after G-CSF administration
Change in Patient Health Questionnaire-9 (PHQ-9) Depression Score (0-27)
Change in PHQ-9 depression score (0-27). Cut-offs: 5-9 mild, 10-14 moderate, 15-19 moderately severe, ≥20 severe depression. Turkish validation available.
Time frame: Baseline and 1 week after G-CSF administration
Change in Generalized Anxiety Disorder-7 (GAD-7) Score (0-21)
Change in GAD-7 anxiety score (0-21). Cut-offs: 5 mild, 10 moderate, ≥15 severe anxiety. Turkish validation available.
Time frame: Baseline and 1 week after G-CSF administration
Change in Beck Depression Inventory (BDI) Score (0-63)
Change in BDI score (0-63). Cut-offs: 0-9 minimal, 10-18 mild, 19-29 moderate, 30-63 severe depression. Turkish validation available.
Time frame: Baseline and 1 week after G-CSF administration
Change in Pittsburgh Sleep Quality Index (PSQI) Score (0-21)
Change in PSQI global score (0-21). Higher scores indicate poorer sleep quality. A global score \>5 indicates poor sleep. Turkish validation available.
Time frame: Baseline and 1 week after G-CSF administration
Analgesic Use During Study Period (%)
Type and frequency of analgesics (NSAIDs, opioids, antihistamines) and non-pharmacological supportive measures recorded during follow-up.
Time frame: Baseline to 1 week after G-CSF administration
Correlation Between Change in Visual Analog Scale (VAS, 0-10) Bone Pain Score and Supportive Care Strategy
Exploratory correlation of supportive care type (NSAIDs, opioids, antihistamines, non-pharmacological measures) with change in VAS pain score.
Time frame: Baseline to 1 week after G-CSF administration
Correlation Between Change in Visual Analog Scale (VAS, 0-10) Bone Pain Score and G-CSF Formulation
Exploratory correlation of change in VAS pain score according to G-CSF formulation used (filgrastim, pegfilgrastim, lipegfilgrastim).
Time frame: Baseline to 1 week after G-CSF administration
Correlation Between Change in Visual Analog Scale (VAS, 0-10) Bone Pain Score and Baseline Demographic/Clinical Factors
Correlation of change in VAS pain score with baseline factors (age, sex, ECOG performance status, tumor type).
Time frame: Baseline to 1 week after G-CSF administration
Correlation Between Change in Visual Analog Scale (VAS, 0-10) Bone Pain Score and Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Score (0-100)
Correlation analysis between change in VAS pain score and change in EORTC QLQ-C30 global health/quality-of-life score.
Time frame: Baseline to 1 week after G-CSF administration
Correlation Between Change in Visual Analog Scale (VAS, 0-10) Bone Pain Score and Change in Functional Assessment of Cancer Therapy-General (FACT-G) and Functional Assessment of Cancer Therapy-Fatigue (FACT-F) Scores
Correlation analysis between change in VAS pain score and change in FACT-G total (0-108) and FACT-F fatigue subscale (0-52).
Time frame: Baseline to 1 week after G-CSF administration
Correlation Between Change in Visual Analog Scale (VAS, 0-10) Bone Pain Score and Change in Pittsburgh Sleep Quality Index (PSQI) Global Score (0-21)
Correlation between change in VAS pain score and change in PSQI global score (0-21; \>5 indicates poor sleep quality).
Time frame: Baseline to 1 week after G-CSF administration
Predictors of Clinically Meaningful Pain Improvement (≥20% Reduction in Visual Analog Scale [VAS] Score)
Multivariable logistic regression to identify predictors of ≥20% reduction in VAS pain score (Yes/No) at 1 week, including supportive care type, G-CSF formulation, and baseline characteristics.
Time frame: Baseline to 1 week after G-CSF administration
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Ankara Etlik City Hospital