Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy

• Status: Completed
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Breast cancer patients who received docetaxel chemotherapy were randomly divided into two groups; experimental group: the patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day; control group: observation. Primary endpoint: total incidence of fluid retention. Secondary endpoints: severity and duration of fluid retention, change in quality of life score.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial People's Hospital

Criteria

Inclusion Criteria:

• Signed informed consent

• Age ≥18 years

• Diagnosed with breast cancer

• ECOG 0-2

• Received chemotherapy with docetaxel

Exclusion Criteria:

• Existed peripheral edema, ascites and pleural or pericardial effusion

• Serum creatinine exceeds 1.5 times of the upper normal limit

• Total serum bilirubin exceeds 1.25 times of the upper normal limit, or ASAT exceeds 2 times of the upper normal limit