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Completed

NCT Number: NCT04637308

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

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.

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Key information

Conditions

Fluid Retention Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Succinylated gelatin

Drug

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 outcomes

  1. Total incidence of fluid retention

    Time frame: 6 months

    Total incidence of peripheral edema, ascites and pleural or pericardial effusion of patients during the period of docetaxel chemotherapy

Secondary outcomes

  1. severity of fluid retention

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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