Prospective Observational Evaluation of Supportive Care Strategies for G-CSF-Induced Bone Pain and Associated Symptoms in Patients With Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Etlik City Hospital Medical Oncology Department
RECRUITING
Ankara
Contact Information
Primary
Enes Yeşilbaş, MD
yesilbas126@gmail.com
+905321795590
Backup
Galip Can Uyar, MD
g.can_uyar@hotmail.com
+905065963812
Time Frame
Start Date: 2025-09-27
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 128
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ankara Etlik City Hospital

This content was sourced from clinicaltrials.gov

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