Solid TumorsGCSF-PAINNCT07192770
G-CSF-Related Bone Pain and Supportive Care Strategies in Patients With Solid Tumors
An observational study of Solid Tumors and Chemotherapy-induced Neutropenia, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Chemotherapy-induced Neutropenia
- What is being tested?
- Filgrastim (G-CSF), Naproxen and Loratadine
- Type of treatment
- Pill or oral medicine
- How many people
- 190 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 27 Sep 2025to 19 Feb 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 years or older with histologically or cytologically confirmed solid tumors receiving systemic chemotherapy and primary or secondary filgrastim prophylaxis at Ankara Etlik City Hospital or Gazi University Faculty of Medicine. Patients receiving neoadjuvant, adjuvant, or palliative treatment were eligible, and each participant contributed one treatment cycle.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Etlik City Hospital Medical Oncology Department
Ankara, Yenimahalle, 06270
Gazi University, Medical Oncology Department
Ankara, Çankaya
About this study
Official title: Bone Pain and Multidimensional Symptom Burden Following G-CSF Prophylaxis in Patients With Solid Tumors
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.
Read the 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.
- Conditions
- Solid Tumors, Chemotherapy-induced Neutropenia
- Being tested
- Filgrastim (G-CSF), Naproxen, Loratadine
- Keywords
- G-CSF, Bone Pain, Chemotherapy Supportive Care, Quality of Life, Fatigue, Depression, Sleep Quality, Patient-Reported Outcomes, G-CSF-Induced Bone Pain
- Medical subject headings
- Fatigue, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filgrastim (G-CSF)Biological
Also called Zarzio, 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.
NaproxenDrug
Also called Analgesics
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.
LoratadineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Naproxen Alone | Patients receiving chemotherapy with filgrastim prophylaxis who received physician-selected supportive care with naproxen 500 mg once daily for 5 days, beginning on the first day of filgrastim administration. Treatment allocation was not randomized. Receives: Biological: Filgrastim (G-CSF); Drug: Naproxen | |
| Naproxen Plus Loratadine | Patients receiving chemotherapy with filgrastim prophylaxis who received physician-selected supportive care with naproxen 500 mg once daily plus loratadine 10 mg once daily for 5 days, beginning on the first day of filgrastim administration. Treatment allocation was not randomized. Receives: Biological: Filgrastim (G-CSF); Drug: Naproxen; Drug: Loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Rating Scale (NRS) Bone Pain Score From Baseline to 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.
Measured: Baseline and study day 8
Secondary outcomes (9)
Clinically Significant Granulocyte Colony-Stimulating Factor-Induced Bone Pain
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.
Measured: Baseline to study day 8
Numeric Rating Scale Bone Pain Score on 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.
Measured: Study day 8
Increase of at Least 2 Points in Numeric Rating Scale Bone Pain Score From Baseline
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.
Measured: Baseline to study day 8
Numeric Rating Scale Bone Pain Score of 5 or Higher on Study Day 8
Proportion of participants with a Numeric Rating Scale bone pain score of 5 or higher on study day 8.
Measured: Study Day 8
Severe Bone Pain on 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.
Measured: Study day 8
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Domain Scores
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.
Measured: Baseline and study day 8
Change in Generalized Anxiety Disorder 7-Item Scale Score
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.
Measured: Baseline and study day 8
Change in Beck Depression Inventory Score
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.
Measured: Baseline and study day 8
Change in Pittsburgh Sleep Quality Index Global Score
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.
Measured: Baseline and study day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start27 Sep 2025
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
- Investigators
- Enes Yeşilbaş, MD, Principal investigator, Etlik City Hospital Medical Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192770
- Sponsor's protocol ID
- AEŞH-EK-2025-196
- Other IDs
- AEŞH-EK-2025-196
- Acronym
- GCSF-PAIN
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No