Trials / Completed
CompletedNCT04637308
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Guangdong Provincial People's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-09-01
- Primary completion
- 2020-09-30
- Completion
- 2020-09-30
- First posted
- 2020-11-19
- Last updated
- 2020-11-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04637308. Inclusion in this directory is not an endorsement.