Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT05841186

Correlation of Timing of Pegfilgrastim Administration and PIBP.

Led by Guangdong Provincial People's Hospital · Updated on 2024-09-19

156

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Correlation of Timing of Pegfilgrastim Administration and PIBP.

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 18 years and less than or equal to 70 years
  • Diagnosed with primary breast cancer confirmed by pathology or histology
  • Able to receive chemotherapy as scheduled
  • Able to understand Chinese and complete study questionnaires independently
  • Provided written informed consent
  • No need for regular use of prescription or over-the-counter drugs for pre-existing chronic pain
Not Eligible

You will not qualify if you...

  • Currently experiencing bone pain from other diseases
  • Allergy or contraindication to chemotherapy drugs or pegfilgrastim
  • Previous use of pegfilgrastim
  • Previously received chemotherapy
  • Pregnant or breastfeeding
  • Having other primary malignant tumors concurrently

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Guangzhou, Guangdong, China, 510080

Actively Recruiting

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Research Team

K

Kun Wang, professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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