Correlation of Timing of Pegfilgrastim Administration and the Improvement of PIBP and PRO.

Correlation of Timing of Pegfilgrastim Administration and the Improvement of PIBP(Paclitaxel Induced-bone Pain) and PRO (Patient-reported Outcomes).

Pegfilgrastim induced-bone pain is a common and important clinical problem. Currently, there is no effective solution. The bone pain it causes usually begins on the day of pegfilgrastim administration. Chemotherapy can also cause pain, which typically begins 24 to 48 hours after the completion of chemotherapy and lasts for 3 to 5 days. Regarding the timing of pegfilgrastim administration, the NCCN (National Comprehensive Cancer Network) guidelines suggest that 2 to 4 days after completing the chemotherapy is reasonable. In contrast, pegfilgrastim often be administrated 24 to 48 hours after finishing the chemotherapy in current clinical practice. Bone pain may be alleviated by delaying pegfilgrastim administration until 72 hours after the completion of chemotherapy to reduce the superimposed pain caused by chemotherapy and Pegfilgrastim.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Chemotherapy; Bone Pain; Patient-reported Outcomes; Pegfilgrastim
• Intervention / Treatment: Other: Timing of pegfilgrastim administration

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kun Wang, professor; Phone Number: 13922118086; Email: gzwangkun@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 malignant breast tumor.
3. Able to receive the scheduled chemotherapy regimen as scheduled and the
4. chemotherapy regimen is an intermediate to high risk febrile neutropenia regimen.
5. Able to fill out questionnaires independently

Exclusion Criteria:

1. Suffering from severe bone pain due to other diseases currently (defined as bone pain >5 points on a 0-10 Numerical Rating Scale due to non-breast malignancies and their related treatments).
2. Allergy or contraindication to chemotherapeutic agents or pegfilgrastim.
3. Previous use of pegfilgrastim.
4. Pregnancy or lactation.
5. Refused to sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 24h group; Pegfilgrastim is administrated 24 hours after completing the chemotherapy in the 24-hour group.	Other: Timing of pegfilgrastim administration; Timing of pegfilgrastim administration
Other: 48h group; Pegfilgrastim is administrated 48hours after completing the chemotherapy in the 48-hour group.	Other: Timing of pegfilgrastim administration; Timing of pegfilgrastim administration
Other: 72h group; Pegfilgrastim is administrated 72 hours after completing the chemotherapy in the 72-hour group.	Other: Timing of pegfilgrastim administration; Timing of pegfilgrastim administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The area under the curve (AUC) for worst bone pain for days 1 through 8 (day 1 is defined as the day of pegfilgrastim administration) in cycle 1.	Measured by Brief Pain Inventory-Short Form	Days 1 through 8 (day 1 is defined as the day of pegfilgrastim administration).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bone pain	Measured by Brief Pain Inventory-Short Form	Days 1 through 8 (day 1 is defined as the day of pegfilgrastim administration).
Incidence of severe bone pain	Measured by Brief Pain Inventory-Short Form	Days 1 through 8 (day 1 is defined as the day of pegfilgrastim administration).
Duration of bone pain	Measured by Brief Pain Inventory-Short Form	Days 1 through 8 (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	Days 1 through 8 (day 1 is defined as the day of pegfilgrastim administration).
Incidence of febrile neutropenia	Measured by thermometer and routine blood tests.	Monitor axillary temperature daily and do routine blood tests on the seventh day of each cycle.
Leukocyte count	Measured routine blood tests.	Do routine blood tests on the seventh day of each cycle.
Absolute neutrophil count	Measured routine blood tests.	Do routine blood tests on the seventh day of each cycle.
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.
The area under the curve (AUC) for worst bone pain for days 1 through 8 (day 1 is defined as the day of pegfilgrastim administration) in every cycle.	Measured by Brief Pain Inventory-Short Form	Days 1 through 8 (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 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.
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.

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Kun Wang, professor, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 31, 2025
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; chemotherapy; patient-reported outcomes; pegfilgrastim; bone pain
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: KY-Q-2022-474-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No