Solid Tumors, Chemotherapy-induced Neutropenia
Conditions
Keywords
G-CSF, Bone Pain, Chemotherapy Supportive Care, Quality of Life, Fatigue, Depression, Sleep Quality, Patient-Reported Outcomes, G-CSF-Induced Bone Pain
Brief summary
This prospective two-center observational cohort study evaluated G-CSF-related bone pain and multidimensional symptom burden in adults with solid tumors receiving chemotherapy and filgrastim prophylaxis. Participants received one of two physician-selected supportive-care strategies as part of routine clinical practice: naproxen alone or naproxen plus loratadine. Pain was assessed using an 11-point Numeric Rating Scale (NRS) at baseline and on study day 8, with study day 1 defined as the first day of filgrastim administration. Patient-reported outcomes included the EORTC QLQ-C30, GAD-7, Beck Depression Inventory, and Pittsburgh Sleep Quality Index. A total of 190 patients were enrolled at Ankara Etlik City Hospital and Gazi University Faculty of Medicine.
Detailed description
This prospective observational cohort study was conducted at Ankara Etlik City Hospital and Gazi University Faculty of Medicine in Ankara, Türkiye. Adults with histologically or cytologically confirmed solid tumors receiving systemic chemotherapy with primary or secondary G-CSF prophylaxis were enrolled. Participants could be enrolled during neoadjuvant, adjuvant, or palliative treatment, and each participant contributed one treatment cycle. All participants received filgrastim beginning at least 24 hours after chemotherapy for 5 consecutive days. In routine clinical practice, patients weighing 60 kg or less received filgrastim 30 million units (300 micrograms) daily and those weighing more than 60 kg received 48 million units (480 micrograms) daily. No participant received pegfilgrastim or lipegfilgrastim. Treating physicians selected one of two supportive-care strategies without random allocation: naproxen 500 mg once daily or naproxen 500 mg plus loratadine 10 mg once daily. Both strategies were initiated on the first day of filgrastim administration and continued for 5 days. Participants rated current bone pain using an 11-point Numeric Rating Scale (NRS; 0=no pain, 10=worst imaginable pain) at baseline and on study day 8. At the same time points, participants completed the EORTC QLQ-C30, Generalized Anxiety Disorder-7 (GAD-7), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). The study characterized the frequency and severity of G-CSF-related bone pain, compared pain and patient-reported outcomes between the two physician-selected supportive-care strategies, evaluated factors associated with clinically significant pain, and examined associations between worsening pain and changes in physical, functional, and psychosocial outcomes.
Interventions
BIOLOGICALFilgrastim (G-CSF)
Filgrastim was administered as part of routine clinical care beginning at least 24 hours after completion of chemotherapy and continued once daily for 5 consecutive days. Patients weighing 60 kg or less received 300 micrograms daily, whereas patients weighing more than 60 kg received 480 micrograms daily.
DRUGNaproxen
Naproxen 500 mg was administered orally once daily for 5 days, beginning on the first day of filgrastim administration, as part of physician-selected routine supportive care.
DRUGLoratadine
Loratadine 10 mg was administered orally once daily for 5 days, beginning on the first day of filgrastim administration, together with naproxen as part of physician-selected routine supportive care.
Sponsors
Ankara Etlik City Hospital
Gazi University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Histologically or cytologically confirmed solid tumor * Receiving systemic chemotherapy with primary or secondary filgrastim prophylaxis * Eastern Cooperative Oncology Group performance status 0-3 * Written informed consent provided
Exclusion criteria
* Known bone metastases * Active opioid use at enrollment * Use of a nonsteroidal anti-inflammatory drug, opioid, or antihistamine within 2 days before enrollment, except for single doses administered before blood transfusion * Cognitive or communication impairment preventing completion of study questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Rating Scale (NRS) Bone Pain Score From Baseline to Study Day 8 | Baseline and study day 8 | Patient-reported current bone pain intensity was assessed using an 11-point Numeric Rating Scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. Change was calculated as the study day 8 score minus the baseline score, with positive values indicating worsening pain. Study day 1 was defined as the day of the first filgrastim dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Granulocyte Colony-Stimulating Factor-Induced Bone Pain | Baseline to study day 8 | Clinically significant granulocyte colony-stimulating factor-induced bone pain was defined as a Numeric Rating Scale bone pain score of 5 or higher on study day 8 together with an increase of at least 2 points from baseline. |
| Numeric Rating Scale Bone Pain Score on Study Day 8 | Study day 8 | Patient-reported current bone pain intensity on study day 8 was assessed using an 11-point Numeric Rating Scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. |
| Increase of at Least 2 Points in Numeric Rating Scale Bone Pain Score From Baseline | Baseline to study day 8 | Proportion of participants with an increase of at least 2 points in the Numeric Rating Scale bone pain score from baseline to study day 8. |
| Numeric Rating Scale Bone Pain Score of 5 or Higher on Study Day 8 | Study Day 8 | Proportion of participants with a Numeric Rating Scale bone pain score of 5 or higher on study day 8. |
| Severe Bone Pain on Study Day 8 | Study day 8 | Proportion of participants with severe bone pain on study day 8, defined as a Numeric Rating Scale bone pain score of 7 or higher. |
| Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Domain Scores | Baseline and study day 8 | Changes from baseline to study day 8 were evaluated across all 15 standard domains of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, including global health status and quality of life, five functioning scales, and nine symptom scales or individual symptom items. Scores were transformed to a 0 to 100 scale according to the standard scoring algorithm. Higher global health and functioning scores indicate better status, whereas higher symptom scores indicate greater symptom burden. |
| Change in Generalized Anxiety Disorder 7-Item Scale Score | Baseline and study day 8 | The Generalized Anxiety Disorder 7-item Scale consists of 7 items, each scored from 0 to 3, yielding a total score ranging from 0 to 21. Higher total scores indicate greater anxiety symptom burden. Change in the total score from baseline to study day 8 was evaluated, with an increase indicating worsening anxiety symptoms. |
| Change in Beck Depression Inventory Score | Baseline and study day 8 | The Beck Depression Inventory consists of 21 items, each scored from 0 to 3, yielding a total score ranging from 0 to 63. Higher total scores indicate greater depressive symptom burden. Change in the total score from baseline to study day 8 was evaluated, with an increase indicating worsening depressive symptoms. |
| Change in Pittsburgh Sleep Quality Index Global Score | Baseline and study day 8 | The Pittsburgh Sleep Quality Index assesses seven components of sleep quality, each scored from 0 to 3. The seven component scores are summed to produce a global score ranging from 0 to 21. Higher global scores indicate poorer sleep quality, and a global score greater than 5 indicates poor sleep quality. Change in the global score from baseline to study day 8 was evaluated, with an increase indicating worsening sleep quality. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOREnes Yeşilbaş, MD
Etlik City Hospital Medical Oncology Department
Outcome results
None listed