Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05841186

Correlation of Timing of Pegfilgrastim Administration and PIBP.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pegfilgrastim Bone Pain Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy Neoplasms Neoplasms by Site Patient-reported Outcomes Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Kun Wang, professor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Timing of pegfilgrastim administration

Other

Timing of pegfilgrastim administration

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of bone pain

    Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).

    Measured by Brief Pain Inventory-Short Form

  2. Incidence of severe bone pain

    Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).

    Measured by Brief Pain Inventory-Short Form

  3. Duration of bone pain and severe bone pain

    Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).

    Measured by Brief Pain Inventory-Short Form

  4. 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).

    Measured by Brief Pain Inventory-Short Form

  5. 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.

    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.

  6. 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.

    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.

  7. 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.

    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.

  8. Analgesic use

    Time frame: Days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration).

    According to the diary written by the patient about the use of the analgesic.

  9. 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).

    Measured by Brief Pain Inventory-Short Form

  10. 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.

    Measured by blood routine tests.

  11. 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.

    Measured by thermometer and blood routine tests.

  12. 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.

    Measured by blood routine tests.

  13. 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.

    Measured by blood routine tests.

Study contacts

Contact information is provided by the study sponsor or research team.

Kun Wang, professor

CONTACT

[email protected]

13922118086

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 3, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.