Cancer patients with comorbid diabetes mellitus, heart failure, or chronic kidney disease Cancer chemotherapy,SGLT2 inhibitors,Oral nutritional supplements,Comorbidities,Supportive care
Conditions
Interventions
This retrospective electronic medical record (EMR) study aims to investigate the real-world impact of SGLT2 inhibitors on the nutritional status of cancer patients. The study will target adult patient
Sponsors
Kamoshida Toshiro
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years or older. Patients currently receiving cancer drug therapy at Hitachi General Hospital. Patients with a history of diabetes mellitus, heart failure, or chronic kidney disease Patients currently receiving continuous treatment with or newly initiating an SGLT2 inhibitor (e.g., empagliflozin, dapagliflozin, canagliflozin). Patients who are capable of oral intake and for whom the consumption of Oral Nutritional Supplements (ONS) is feasible. Patients who understood the study details and did not express a desire to opt out of the study.
Exclusion criteria
Exclusion criteria: Patients with dysphagia or severe gastrointestinal symptoms that make ONS intake difficult. Patients with severe hepatic impairment (Child-Pugh class C). Patients with end-stage renal disease (currently on dialysis or with eGFR < 30 mL/min/1.73m). Patients with unstable metabolic status due to severe infection or acute illness. Patients with a history or high risk of diabetic ketoacidosis (e.g., low insulin secretion type, type 1 diabetes). Advanced cancer patients with a prognosis estimated to be less than 3 months. Patients concurrently participating in other clinical trials or interventional studies. Patients judged by the attending physician to be inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Lean Body Mass (LBM), which represents the total weight of skeletal muscle, bone, internal organs, and body fluids. | — |
Secondary
| Measure | Time frame |
|---|---|
| Appetite score,Functional Assessment of Anorexia/Cachexia Therapy,Dietary intake,Body weight,Physical function,Body composition,Blood test parameters (or Clinical laboratory test values),Safety evaluation (or Assessment of adverse events),Urinary glucose excretion (Estimated Urinary Glucose-to-Creatinine Ratio: UGCR) | — |
Contacts
Public ContactAimono Yuka
Hitachi General Hospital
Outcome results
None listed