Cancer, Edema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Pathologically diagnosed as cancer (2) Diagnosed with Grade 2 peripheral edema due to MET inhibitors (3) Disfunction due to edema, fluid retention, increased body weight, fatigue, shortness of breath, etc. (4) Left ventricular ejection fraction is 50% or more (5) BNP 18.4 pg/mL or higher (or NTproBNP 55pg/mL or higher) (6) Written informed consent was obtained
Exclusion criteria
Exclusion criteria: (1) Furosemide and Empagliflozin are not available (2) SGLT2 inhibitor or Furosemide was used (3) History of type 1 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of patients who showed improvement in limb circumference at 3~5 weeks after starting furosemide and empagliflozin | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Furosemide and empagliflozin are initiated for peripheral edema, and at 3-5 weeks, the grade of peripheral edema, stage classification of lymphedema, and assessment using InBody S10 are used to assess the proportion of patients whose edema has improved. (2) For edema caused by MET inhibitors, the changes in limb circumference, the grade of peripheral edema, the stage classification of lymphedema, and the evaluation using InBody S10 will be assessed during the period when furosemide, empagliflozin is continued, to confirm the proportion of improvement in patients with edema. (3) Adverse events are monitored at 3-5 weeks after starting furosemide and empagliflozin for MET inhibitor-induced edema, as well as during the period when furosemide and empagliflozin, or are continued. (4) The effect of edema caused by MET inhibitors on cancer treatment will be assessed at 3-5 weeks after starting furosemide and empagliflozin, and during the period when furosemide and empagliflozin are continued. (5) Body weight is evaluated at 3-5 weeks after starting furosemide and empagliflozin, and during the period when furosemide and empagliflozin are continued. (6) Check the changes in NT-proBNP or BNP at 3-5 weeks after starting furosemide and empagliflozin and during the period of continuing furosemide and/or empagliflozin for heart failure with edema due to MET inhibitors. | — |
Contacts
Shizuoka Cancer Center