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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fluid Retention

Intervention / Treatment
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* Drug: Succinylated gelatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Succinylated gelatin<br>The patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day. | Drug: Succinylated gelatin<br>* 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.<br>|
| No Intervention: Control<br>Observation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid Retention, Chemotherapy, Succinylated gelatin, Breast cancer