CompletedNot Applicable

G-CSF-Induced Bone Pain and Supportive Care Approaches

Turkey (Türkiye)225 participantsStarted 2025-09-27

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Visual Analog Scale (VAS) Bone Pain Score (0-10)

Timeframe: Baseline and 1 week after G-CSF administration

Trial details

NCT IDNCT07192770

SponsorAnkara Etlik City Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2026-02-19

View on ClinicalTrials.gov More Solid Tumors trials