Back to resultsSuccinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
Primary Purpose
Fluid Retention
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Succinylated gelatin
Sponsored by
About this trial
This is an interventional prevention trial for Fluid Retention focused on measuring Fluid Retention, Chemotherapy, Succinylated gelatin, Breast cancer
Eligibility Criteria
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
Sites / Locations
- Guangdong General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Succinylated gelatin
Control
Arm Description
The patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day.
Observation.
Outcomes
Primary Outcome Measures
Total incidence of fluid retention
Total incidence of peripheral edema, ascites and pleural or pericardial effusion of patients during the period of docetaxel chemotherapy
Secondary Outcome Measures
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.
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)
Full Information
NCT ID
NCT04637308
First Posted
November 15, 2020
Last Updated
November 15, 2020
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04637308
Brief Title
Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
Official Title
A Randomized, Phase II Study of Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Retention
Keywords
Fluid Retention, Chemotherapy, Succinylated gelatin, Breast cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Succinylated gelatin
Arm Type
Experimental
Arm Description
The patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Observation.
Intervention Type
Drug
Intervention Name(s)
Succinylated gelatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total incidence of fluid retention
Description
Total incidence of peripheral edema, ascites and pleural or pericardial effusion of patients during the period of docetaxel chemotherapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
severity of fluid retention
Description
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.
Time Frame
6 months
Title
change in Functional Assessment of Cancer Therapy-Breast subscale score
Description
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)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Wang, MD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
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