Timing of pegfilgrastim administration and its effects on bone pain in breast cancer patients
Correlation of Timing of Pegfilgrastim Administration and PIBP(Pegfilgrastim-induced Bone Pain)
This study is testing if changing when pegfilgrastim is given can help reduce bone pain in breast cancer patients undergoing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05841186 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between the timing of pegfilgrastim administration and the occurrence of pegfilgrastim-induced bone pain (PIBP) in patients undergoing chemotherapy for breast cancer. It aims to address the high incidence of PIBP, which affects a significant number of patients despite current preventive measures. Participants will be required to complete study-related questionnaires to assess their experiences with bone pain. The study focuses on patients aged 18 to 70 with confirmed breast cancer who can understand and respond to the study materials in Chinese.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of primary breast cancer who are scheduled to receive chemotherapy.
Not a fit: Patients suffering from bone pain due to other diseases or those with allergies to pegfilgrastim will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of bone pain for breast cancer patients receiving chemotherapy.
How similar studies have performed: While there is limited data on PIBP treatment, the study aims to explore a novel approach to managing this common issue in breast cancer chemotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Department of Breast Cancer, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Kun Wang, professor — Guangdong Provincial People's Hospital
- Study coordinator: Kun Wang, professor
- Email: gzwangkun@126.com
- Phone: 13922118086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.