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

• Sponsor: Guangdong Provincial People's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04637308
• Collaborator: (none)
• Enrollment: 216
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 16.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fluid Retention	Drug: Succinylated gelatin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized, Phase II Study of Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Succinylated gelatin 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; 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.
No Intervention: Control Observation.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong General Hospital	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Guangdong Provincial People's Hospital

Investigators

• Principal Investigator: Kun Wang, MD, Guangdong Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kun Wang, Professor, Guangdong Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT04637308
• Other Study ID Numbers: 20190812
• First Posted: Nov 19, 2020
• Last Update Posted: Nov 19, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kun Wang, Professor, Guangdong Provincial People's Hospital: Fluid Retention; Chemotherapy; Succinylated gelatin; Breast cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Nov 19, 2020