Fluid Retention
Conditions
Keywords
Fluid Retention, Chemotherapy, Succinylated gelatin, Breast cancer
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.
Interventions
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.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
Countries
China
Outcome results
None listed