G-CSF-Induced Bone Pain and Supportive Care Approaches (GCSF-PAIN)

Ankara Etlik City Hospital

Status: Enrolling

Conditions: Chemotherapy-induced Neutropenia; Solid Tumors

Treatments: Biological: Granulocyte colony-stimulating factor (G-CSF); Other: Supportive Care (Analgesic and Non-Pharmacological Strategies)

Study type: Observational

Funder types: Other

Identifiers

NCT07192770

AEŞH-EK-2025-196 (Other Identifier)

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

128 participants in 1 patient group

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.

Treatment:

Other: Supportive Care (Analgesic and Non-Pharmacological Strategies)

Biological: Granulocyte colony-stimulating factor (G-CSF)