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

Phase 2

Completed

• Conditions: Fluid Retention
• Interventions: Drug: Succinylated gelatin

• Registration Number: NCT04637308
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2020-11
• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-11-15
• Last Update Submitted: 2020-11-15
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total incidence of fluid retention	6 months	Total incidence of peripheral edema, ascites and pleural or pericardial effusion of patients during the period of docetaxel chemotherapy

Secondary Outcome Measures

Name	Time	Method
change in Functional Assessment of Cancer Therapy-Breast subscale score	6 months	Functional Assessment of Cancer Therapy-Breast（FACT-B）subscale during the period of docetaxel chemotherapy was assessed; the scores range from 0 to 144, higher scores mean a better outcome (higher quality of life)
severity of fluid retention	6 months	Severity of peripheral edema, ascites and pleural or pericardial effusion of patients during the period of docetaxel chemotherapy; the severity of pain was evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, ranging from 1 to 3 grades.

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China