Correlation of Timing of Pegfilgrastim Administration and PIBP.

Breast Cancer Clinical Trial

Official title:

Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841186
• Other study ID #: KY-Q-2022-474-02
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Guangdong Provincial People's Hospital
• Contact: Kun Wang, professor
• Phone: 13922118086
• Email: gzwangkun[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age greater than or equal to 18 years and less than or equal to 70 years.

2. Pathologically or histologically confirmed diagnosis of primary breast cancer.

3. Able to receive the chemotherapy regimen as scheduled.

4. Able to understand Chinese and fill out the study-related questionnaires independently.

5. Given written informed consent.

6. There is no need to use prescription or over-the-counter drugs regularly because of pre-existing chronic pain.

Exclusion Criteria:

1. Suffering from bone pain due to other diseases currently.

2. Allergy or contraindication to chemotherapeutic agents or pegfilgrastim.

3. Previous use of pegfilgrastim.

4. Previous received chemotherapy.

5. Pregnancy or breastfeeding.

6. Concurrently accompanied by other primary malignant tumors.

Related Conditions & MeSH terms

• Bone Pain
• Breast Cancer
• Chemotherapy
• Patient-reported Outcomes
• Quality of Life

Intervention

Other:
• Timing of pegfilgrastim administration
Timing of pegfilgrastim administration

Locations

Country	Name	City	State
China	Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The area under the curve (AUC) for worst bone pain 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	Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Secondary	Incidence of bone pain	Measured by Brief Pain Inventory-Short Form	Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Secondary	Incidence of severe bone pain	Measured by Brief Pain Inventory-Short Form	Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Secondary	Duration of bone pain and severe bone pain	Measured by Brief Pain Inventory-Short Form	Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Secondary	Impact of bone pain on daily life and other aspects.	Measured by Brief Pain Inventory-Short Form	Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Secondary	Incidence of febrile neutropenia	Measured by thermometer and routine blood tests.	Patients monitor their axillary temperature daily and do routine blood tests on the seventh day of each cycle.
Secondary	Leukocyte count	Measured by routine blood tests.	Patients do routine blood tests on the seventh day of each cycle.
Secondary	Absolute neutrophil count	Measured by routine blood tests.	Patients do routine blood tests on the seventh day of each cycle.
Secondary	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.	Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
Secondary	The area under the curve (AUC) for worst bone pain 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	Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Secondary	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.	Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
Secondary	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.	Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.
Secondary	Analgesic use	According to the diary written by the patient about the use of the analgesic.	Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).
Secondary	Incidence of neutropenia	Measured by routine blood tests.	Patients do routine blood tests on the seventh day of each cycle.