Hepatocellular Carcinoma, Insulin Resistance
Conditions
Brief summary
Exercise is predicted to have positive effect among patients with hepatocellular carcinoma (HCC). However, little attention has been paid to the role of physical activity with wearable device in the management of HCC patients in the aspect of improvement in insulin resistance. We designed this study to investigate whether personalized exercise with mobile health program improves insulin resistance without decompensation in HCC patients with insulin resistance.
Interventions
BEHAVIORALMobile health
Perform exercise daily with mobile application and wearable device (warm-up, stretching, aerobic, and strengthening). Mobile application: Hepatocellular carcinoma by Second Doctor Wearable device: Dofit
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 20 to 70 years * Patients who were diagnosed with early-stage HCC, defined by modified UICC stage 1 or 2 * Patients with treatment-naive and recurrent HCC who have received treatment and achieved complete response at the time of screening * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Patients with insulin resistance (HOMA-IR \>=2.2)
Exclusion criteria
* Child Pugh class B or C * Alcohol intake \>20g/day * History of decompensation * Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \> 200/120 mmHg) or psychiatric illnesses which limit ability to exercise safely * Who takes insulin sensitizer (sulfonylurea, biguanide, thiazolidinedione, glucagon-like peptide-1 agonist, dipeptidyl peptidase-4 inhibitor) or uses insulin * Uncontrolled diabetes mellitus (Hemoglobin A1c \>10%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of insulin resistance | After 12 weeks | The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (\<2.2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of 6-minute walk test | After 12 and 24 weeks | \- Changes in meters assessed using the 6-minute walk test |
| Improvement of grip strength test | After 12 and 24 weeks | \- Changes in kilograms assessed using grip strength test |
| Improvement of 30-second chair stand test | After 12 and 24 weeks | \- Changes in seconds assessed using 30-second chair stand test |
| Improvement of insulin resistance | After 24 weeks | The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (\<2.2) |
| Improvement of quality of life | After 12 and 24 weeks | Improved score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30 |
| Nutritional status | After 12 and 24 weeks | Comparison of nutrition score using mini nutritional assessment |
| Adverse events | After 12 and 24 weeks | Any adverse events occurred during exercise |
| Improvement of the score of International Physical Activity Questionnaire-Short Form (IPAQ-SF) | After 12 and 24 weeks | \- Changes in metabolic equivalents (METs) per week calculated using IPAQ-SF |
Countries
South Korea
Outcome results
None listed