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Correlation of timing of pegfilgrastim administration and the improvement of paclitaxel induced-bone pain and patient-reported outcomes

Correlation of timing of pegfilgrastim administration and the improvement of paclitaxel induced-bone pain and patient-reported outcomes

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067366
Enrollment
Unknown
Registered
2023-01-05
Start date
2023-01-05
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Group 1:receive pegfilgrastim 24 hours after chemotherapy
Group 2:receive pegfilgrastim 48 hours after chemotherapy
Group 3:receive pegfilgrastim 72 hours after chemotherapy

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-70 years old; 2. Pathologically diagnosed as breast cancer; 3. Patients who can receive the scheduled chemotherapy regimen as scheduled, and the chemotherapy regimen is a middle-to-high-risk febrile neutropenia regimen.

Exclusion criteria

Exclusion criteria: 1. There are currently other diseases that cause severe bone pain (referring to non-breast cancer and related treatments that cause bone pain > 5 points in the digital analog scale of 0-10 points); 2. Allergic to chemotherapy drugs or Shengbai injection or contraindicated in use; 3. Previously used Shengbaizhen.

Design outcomes

Primary

MeasureTime frame
The area under the curve (AUC) for worst bone pain for days 1 through 5 (day 1 is defined as the day of pegfilgrastim administration);

Secondary

MeasureTime frame
Incidence of bone pain;Incidence of severe bone pain;Duration of bone pain;Impact of bone pain on daily life and other aspects;Incidence of febrile neutropenia;Leukocyte count;Patient-reported outcomes;

Countries

China

Contacts

Public ContactKun Wang

Department of Breast Cancer, Guangdong Provincial People's Hospital

gzwangkun@126.com+86 139 2211 8086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026