PegfilgrastimNCT05841186
Correlation of Timing of Pegfilgrastim Administration and PIBP.
A study testing Timing of pegfilgrastim administration in people with Pegfilgrastim and Bone Pain, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
According to the National Comprehensive Cancer Network (NCCN) guidelines, patients receiving high-risk or moderate-risk febrile neutropenia (FN) chemotherapy with at least one risk factor should receive prophylactic granulocyte colony-stimulating factors (G-CSFs). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pegfilgrastim, Bone Pain, Chemotherapy
- What is being tested?
- Timing of pegfilgrastim administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years and less than or equal to 70 years.
- Pathologically or histologically confirmed diagnosis of primary breast cancer.
- Able to receive the chemotherapy regimen as scheduled.
- Able to understand Chinese and fill out the study-related questionnaires independently.
- Given written informed consent.
- There is no need to use prescription or over-the-counter drugs regularly because of pre-existing chronic pain.
Who cannot join
- Suffering from bone pain due to other diseases currently.
- Allergy or contraindication to chemotherapeutic agents or pegfilgrastim.
- Previous use of pegfilgrastim.
- Previous received chemotherapy.
- Pregnancy or breastfeeding.
- Concurrently accompanied by other primary malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
Guangzhou, Guangdong, 510080
Kun Wang, professor
About this study
Official title: Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)
According to the National Comprehensive Cancer Network (NCCN) guidelines, patients receiving high-risk or moderate-risk febrile neutropenia (FN) chemotherapy with at least one risk factor should receive prophylactic granulocyte colony-stimulating factors (G-CSFs). However, pegfilgrastim-induced bone pain (PIBP) remains a common and significant clinical issue without a satisfactory solution. Studies have reported that the incidence rate of PIBP is 71.3%, with severe bone pain occurring in 27.0% of cases. Currently, the available data on PIBP treatment are limited to case reports, reviews, and small randomized controlled trials.
The NCCN guidelines recommend preventive oral non-steroidal anti-inflammatory drugs or antihistamines as the treatment for PIBP. However, even with these preventive measures, the incidence rate of PIBP remains high at 61.1%, with severe bone pain occurring in 19.2% of cases. Severe bone pain can significantly impact the patient's health-related quality of life (HRQol), leading to potential refusal of pegfilgrastim administration and subsequent dose reduction in effective chemotherapy. Ultimately, this may have negative implications for tumor cure rates and patient survival.
Based on previous literature, it appears that delaying the administration of pegfilgrastim may be associated with a lower incidence of PIBP. Therefore, our study aims to investigate the correlation between the timing of pegfilgrastim administration and the occurrence of PIBP.
- Conditions
- Pegfilgrastim, Bone Pain, Chemotherapy, Breast Cancer, Patient-reported Outcomes, Quality of Life
- Being tested
- Timing of pegfilgrastim administration
- Keywords
- pegfilgrastim, bone pain, patient-reported outcomes, chemotherapy, Breast Cancer, health related-quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of pegfilgrastim administrationOther
Timing of pegfilgrastim administration
| Study group | Role | What they receive |
|---|---|---|
| 24h group | Other | Pegfilgrastim is administrated 24 hours after completing the chemotherapy in the 24-hour group. Receives: Other: Timing of pegfilgrastim administration |
| 48h group | Other | Pegfilgrastim is administrated 48hours after completing the chemotherapy in the 48-hour group. Receives: Other: Timing of pegfilgrastim administration |
| 72h group | Other | Pegfilgrastim is administrated 72 hours after completing the chemotherapy in the 72-hour group. Receives: Other: Timing of pegfilgrastim administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the curve (AUC) for daily worst bone pain score for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration) in cycle 1.
Measured by Brief Pain Inventory-Short Form
Measured: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Secondary outcomes (13)
Incidence of bone pain
Measured by Brief Pain Inventory-Short Form
Measured: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Incidence of severe bone pain
Measured by Brief Pain Inventory-Short Form
Measured: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Duration of bone pain and severe bone pain
Measured by Brief Pain Inventory-Short Form
Measured: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Impact of bone pain on daily life and other aspects.
Measured by Brief Pain Inventory-Short Form
Measured: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score.
The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement.
Measured: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Breast Cancer-23 (EORTC QLQ-BR23) Score.
The EORTC QLQ-BR23 is a questionnaire to assess quality of life (QoL), it is composed of 23 questions (items) resulting in 4 functional scales (Body Image, Future Perspective, Sexual Functioning, Sexual Enjoyment) and 4 symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms, Breast Symptoms). All of the scales measures range in score from 0 to 100. Higher score for the functioning scales indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom scales indicate a better quality of life; a negative change from baseline indicates improvement.
Measured: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
Change From Baseline in European Quality of Life-Five Dimension-Five Level Scale (EQ-5D-5L) Score.
The EQ-5D-5L consists of a descriptive system that defines health in terms of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analog scale (VAS) for respondents to rate their current health status from 0 (worst health) to 100 (best imaginable health). A unique EQ-5D-5L health state (or profile) for each patient was generated by combining the results for the dimensions, consisting of a five-digit code. The health states were then converted to a preference-weighted summary score (weights derived from the general population), or EQ-5D-5L health utility index, with higher scores indicating better outcomes, and a positive change from baseline indicates improvement.
Measured: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
Analgesic use
According to the diary written by the patient about the use of the analgesic.
Measured: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
The area under the curve (AUC) for daily worst bone pain score for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration) in every cycle.
Measured by Brief Pain Inventory-Short Form
Measured: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Leukocyte count
Measured by blood routine tests.
Measured: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.
Incidence of febrile neutropenia
Measured by thermometer and blood routine tests.
Measured: Patients monitor their oral temperature daily, and do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.
Incidence of neutropenia
Measured by blood routine tests.
Measured: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.
Absolute neutrophil count
Measured by blood routine tests.
Measured: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start4 May 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PegfilgrastimStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
- Investigators
- Kun Wang, professor, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841186
- Sponsor's protocol ID
- KY-Q-2022-474-02
- Status last verified
- Sep 2024
- First submitted
- 7 Apr 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li P, Chen Y, Lin Y, Zhang X, Cheng M, Zhu T, Gao HF, Zhang L, Li J, Huang N, Chen Y, Liang M, Zhang Y, Huang S, Zheng J, Wu C, Yang C, Wang K. Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain : A Prospective, Randomized, Phase 3 Trial. Ann Intern Med. 2026 May;179(5):656-665. doi: 10.7326/ANNALS-25-02600. Epub 2026 Mar 24.
PubMed 41871353
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)
- ClinicalTrials.gov ID
- NCT05841186
- Acronym / sponsor ID
- KY-Q-2022-474-02
- Conditions
- Pegfilgrastim, Bone Pain, Chemotherapy, Breast Cancer, Patient-reported Outcomes, Quality of Life
- Keywords
- pegfilgrastim, bone pain, patient-reported outcomes, chemotherapy, Breast Cancer, health related-quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the National Comprehensive Cancer Network (NCCN) guidelines, patients receiving high-risk or moderate-risk febrile neutropenia (FN) chemotherapy with at least one risk factor should receive prophylactic granulocyte colony-stimulating factors (G-CSFs). However, pegfilgrastim-induced bone pain (PIBP) remains a common and significant clinical issue without a satisfactory solution. Studies have reported that the incidence rate of PIBP is 71.3%, with severe bone pain occurring in 27.0% of cases. Currently, the available data on PIBP treatment are limited to case reports, reviews, and small randomized controlled trials.
The NCCN guidelines recommend preventive oral non-steroidal anti-inflammatory drugs or antihistamines as the treatment for PIBP. However, even with these preventive measures, the incidence rate of PIBP remains high at 61.1%, with severe bone pain occurring in 19.2% of cases. Severe bone pain can significantly impact the patient's health-related quality of life (HRQol), leading to potential refusal of pegfilgrastim administration and subsequent dose reduction in effective chemotherapy. Ultimately, this may have negative implications for tumor cure rates and patient survival.
Based on previous literature, it appears that delaying the administration of pegfilgrastim may be associated with a lower incidence of PIBP. Therefore, our study aims to investigate the correlation between the timing of pegfilgrastim administration and the occurrence of PIBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 24h group | Other | Other: Timing of pegfilgrastim administrationPegfilgrastim is administrated 24 hours after completing the chemotherapy in the 24-hour group. |
| 48h group | Other | Other: Timing of pegfilgrastim administrationPegfilgrastim is administrated 48hours after completing the chemotherapy in the 48-hour group. |
| 72h group | Other | Other: Timing of pegfilgrastim administrationPegfilgrastim is administrated 72 hours after completing the chemotherapy in the 72-hour group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years and less than or equal to 70 years.
- Pathologically or histologically confirmed diagnosis of primary breast cancer.
- Able to receive the chemotherapy regimen as scheduled.
- Able to understand Chinese and fill out the study-related questionnaires independently.
- Given written informed consent.
Key exclusion criteria (6 listed)
- Suffering from bone pain due to other diseases currently.
- Allergy or contraindication to chemotherapeutic agents or pegfilgrastim.
- Previous use of pegfilgrastim.
- Previous received chemotherapy.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing of pegfilgrastim administrationTiming of pegfilgrastim administration | Other | 24h group, 48h group, 72h group |
Primary outcome
The area under the curve (AUC) for daily worst bone pain score for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration) in cycle 1.
Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Measured by Brief Pain Inventory-Short Form
13 secondary outcomes
Incidence of bone pain
Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Incidence of severe bone pain
Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Duration of bone pain and severe bone pain
Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Impact of bone pain on daily life and other aspects.
Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score.
Time frame: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Breast Cancer-23 (EORTC QLQ-BR23) Score.
Time frame: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
Change From Baseline in European Quality of Life-Five Dimension-Five Level Scale (EQ-5D-5L) Score.
Time frame: Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
Analgesic use
Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
The area under the curve (AUC) for daily worst bone pain score for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration) in every cycle.
Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Leukocyte count
Time frame: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.
Incidence of febrile neutropenia
Time frame: Patients monitor their oral temperature daily, and do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.
Incidence of neutropenia
Time frame: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.
Absolute neutrophil count
Time frame: Patients do blood routine tests on the seventh day of each chemotherapy cycle (Each cycle lasts 28 days, and day 1 denotes the day of chemotherapy completion) and when necessary.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41871353Li P, Chen Y, Lin Y, Zhang X, Cheng M, Zhu T, Gao HF, Zhang L, Li J, Huang N, Chen Y, Liang M, Zhang Y, Huang S, Zheng J, Wu C, Yang C, Wang K. Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain : A Prospective, Randomized, Phase 3 Trial. Ann Intern Med. 2026 May;179(5):656-665. doi: 10.7326/ANNALS-25-02600. Epub 2026 Mar 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun Wang, professor principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of pegfilgrastim administration in people with Pegfilgrastim and Bone Pain, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Wang, professor (13922118086, gzwangkun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the curve (AUC) for daily worst bone pain score for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration) in cycle 1. (time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05841186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.