Correlation of Timing of Pegfilgrastim Administration and PIBP.

NCT05841186 | Recruiting

• 1 other identifier: KY-Q-2022-474-02
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

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.

  Measured by Brief Pain Inventory-Short Form

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

Secondary Outcomes (13)

• Incidence of bone pain

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

• Incidence of severe bone pain

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

• Duration of bone pain and severe bone pain

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

• Impact of bone pain on daily life and other aspects.

  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.

  Before pegfilgrastim administration in the first chemotherapy cycle (baseline), day 7 after each cycle of pegfilgrastim administration.

Study Arms (3)

24h group

OTHER

Pegfilgrastim is administrated 24 hours after completing the chemotherapy in the 24-hour group.

Other: Timing of pegfilgrastim administration

48h group

OTHER

Pegfilgrastim is administrated 48hours after completing the chemotherapy in the 48-hour group.

Other: Timing of pegfilgrastim administration

72h group

OTHER

Pegfilgrastim is administrated 72 hours after completing the chemotherapy in the 72-hour group.

Other: Timing of pegfilgrastim administration

Interventions

Timing of pegfilgrastim administration OTHER

Timing of pegfilgrastim administration

24h group; 48h group; 72h group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kun Wang, professor

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Wang, professor

CONTACT

13922118086; gzwangkun@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 3, 2023
• Study Start: May 4, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)