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

Fluid Retention Clinical Trial

Official title:

A Randomized, Phase II Study of Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637308
• Other study ID #: 20190812
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Fluid Retention

Intervention

Drug:
• Succinylated gelatin
Succinylated gelatin (SG, "Gelofusine"; B. Braun, Crissier, Switzerland) is a clear, inexpensive, safe, colloidal plasma volume-expanding solution, weight-average molecular weight (MWw) 30 kDa.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total incidence of fluid retention	Total incidence of peripheral edema, ascites and pleural or pericardial effusion of patients during the period of docetaxel chemotherapy	6 months
Secondary	severity of fluid retention	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.	6 months
Secondary	change in Functional Assessment of Cancer Therapy-Breast subscale score	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)	6 months