G-CSF-Induced Bone Pain and Supportive Care Approaches

NCT07192770 | Completed

• 1 other identifier: AEŞH-EK-2025-196
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Neutropenia; Solid Tumors

Keywords

G-CSF; Bone Pain; Chemotherapy Supportive Care; Quality of Life; Fatigue; Depression; Sleep Quality; Patient-Reported Outcomes; G-CSF-Induced Bone Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 1 week after G-CSF administration

Secondary Outcomes (8)

• 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)

  Baseline and 1 week after G-CSF administration

• Change in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score (0-108)

  Baseline and 1 week after G-CSF administration

• Change in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) Subscale Score (0-52)

  Baseline and 1 week after G-CSF administration

• Change in Patient Health Questionnaire-9 (PHQ-9) Depression Score (0-27)

  Baseline and 1 week after G-CSF administration

• Change in Generalized Anxiety Disorder-7 (GAD-7) Score (0-21)

  Baseline and 1 week after G-CSF administration

Other Outcomes (7)

• Correlation Between Change in Visual Analog Scale (VAS, 0-10) Bone Pain Score and Supportive Care Strategy

  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

  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

  Baseline to 1 week after G-CSF administration

Study Arms (1)

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.

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

Interventions

Granulocyte colony-stimulating factor (G-CSF) 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.

Also known as: Lipegfilgrastim, Filgrastim, Pegfilgrastim

Patients Receiving G-CSF During Chemotherapy

Supportive Care (Analgesic and Non-Pharmacological Strategies) 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.

Also known as: Non-drug supportive measures, Analgesics

Patients Receiving G-CSF During Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital Medical Oncology Department

Ankara, Yenimahalle, 06270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue; Depression; Sleep Initiation and Maintenance Disorders

Interventions

Granulocyte Colony-Stimulating Factor; pegfilgrastim; Filgrastim; Palliative Care; Analgesics

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Enes Yeşilbaş, MD

  Etlik City Hospital Medical Oncology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncology Specialist

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 25, 2025
• Study Start: September 27, 2025
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)