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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Completed; Phase 2

Conditions: Fluid Retention

Treatments: Drug: Succinylated gelatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04637308

20190812

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Succinylated gelatin

Experimental group

Description:

The patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day.

Treatment:

Drug: Succinylated gelatin

Control

No Intervention group

Description:

Observation.