G-CSF-Induced Bone Pain and Supportive Care Approaches

NCT ID: NCT07192770

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-27
• Study Completion Date: 2026-01-15

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 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.

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, 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.

Conditions

Solid Tumors; Chemotherapy-induced Neutropenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients Receiving G-CSF During Chemotherapy

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.

Granulocyte colony-stimulating factor (G-CSF)

Intervention Type: BIOLOGICAL

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.

Supportive Care (Analgesic and Non-Pharmacological Strategies)

Intervention Type: OTHER

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.

Interventions

Granulocyte colony-stimulating factor (G-CSF)

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.

Intervention Type: BIOLOGICAL

Supportive Care (Analgesic and Non-Pharmacological Strategies)

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.

Intervention Type: OTHER

Other Intervention Names

Lipegfilgrastim; Filgrastim; Pegfilgrastim; Non-drug supportive measures; Analgesics

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Galip Can Uyar

Medical Oncology Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enes Yeşilbaş, MD

Role: PRINCIPAL_INVESTIGATOR

Etlik City Hospital Medical Oncology Department

Locations

Etlik City Hospital Medical Oncology Department

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Enes Yeşilbaş, MD

Role: CONTACT

yesilbas126@gmail.com

+905321795590

Galip Can Uyar, MD

Role: CONTACT

g.can_uyar@hotmail.com

+905065963812

Facility Contacts

Galip Can Uyar, MD

Role: primary

g.can_uyar@hotmail.com

+905065963812

Enes Yeşilbaş, MD

Role: backup

yesilbas126@gmail.com

+905321795590

Other Identifiers

AEŞH-EK-2025-196

Identifier Type: OTHER

Identifier Source: secondary_id

AEŞH-EK-2025-196

Identifier Type: -

Identifier Source: org_study_id