Prospective Observational Evaluation of Supportive Care Strategies for G-CSF-Induced Bone Pain and Associated Symptoms in Patients With Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Change in Visual Analog Scale (VAS) Bone Pain Score (0-10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Granulocyte colony-stimulating factor (G-CSF) (Biological)
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.
干预措施: Supportive Care (Analgesic and Non-Pharmacological Strategies) (Other)
结局指标
主要结局
Change in Visual Analog Scale (VAS) Bone Pain Score (0-10)
时间窗: Baseline and 1 week after G-CSF administration
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.
次要结局
- 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 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)
- Change in Beck Depression Inventory (BDI) Score (0-63)(Baseline and 1 week after G-CSF administration)
- Change in Pittsburgh Sleep Quality Index (PSQI) Score (0-21)(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)
- Analgesic Use During Study Period (%)(Baseline to 1 week after G-CSF administration)
研究者
Galip Can Uyar
Medical Oncology Specialist
Ankara Etlik City Hospital