Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
A Randomized, Phase II Study of Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
1 other identifier
interventional
216
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedFirst Submitted
Initial submission to the registry
November 15, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedNovember 19, 2020
November 1, 2020
1.1 years
November 15, 2020
November 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
severity of fluid retention
6 months
change in Functional Assessment of Cancer Therapy-Breast subscale score
6 months
Study Arms (2)
Succinylated gelatin
EXPERIMENTALThe patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day.
Control
NO INTERVENTIONObservation.
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.
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Age ≥18 years
- Diagnosed with breast cancer
- ECOG 0-2
- Received chemotherapy with docetaxel
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kun Wang, MD
Guangdong Provincial People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 15, 2020
First Posted
November 19, 2020
Study Start
September 1, 2019
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
November 19, 2020
Record last verified: 2020-11