Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04649671
Other study ID # SMC2020-06-037
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2, 2021
Est. completion date March 2, 2023

Study information

Verified date March 2023
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date March 2, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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%)

Study Design


Intervention

Behavioral:
Mobile 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

Locations

Country Name City State
Korea, Republic of Moon Seok Choi Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of insulin resistance The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2) After 12 weeks
Secondary Improvement of insulin resistance The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2) After 24 weeks
Secondary Improvement of 6-minute walk test - Changes in meters assessed using the 6-minute walk test After 12 and 24 weeks
Secondary Improvement of grip strength test - Changes in kilograms assessed using grip strength test After 12 and 24 weeks
Secondary Improvement of 30-second chair stand test - Changes in seconds assessed using 30-second chair stand test After 12 and 24 weeks
Secondary Improvement of the score of International Physical Activity Questionnaire-Short Form (IPAQ-SF) - Changes in metabolic equivalents (METs) per week calculated using IPAQ-SF After 12 and 24 weeks
Secondary Improvement of quality of life Improved score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30 After 12 and 24 weeks
Secondary Nutritional status Comparison of nutrition score using mini nutritional assessment After 12 and 24 weeks
Secondary Adverse events Any adverse events occurred during exercise After 12 and 24 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04209491 - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed NCT03963206 - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) Phase 4
Completed NCT03268499 - TACE Emulsion Versus Suspension Phase 2
Recruiting NCT05044676 - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting NCT05263830 - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting NCT05095519 - Hepatocellular Carcinoma Imaging Using PSMA PET/CT Phase 2
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Completed NCT05068193 - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers Phase 1
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Active, not recruiting NCT04039607 - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma Phase 3
Terminated NCT03970616 - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03642561 - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE Phase 2/Phase 3
Completed NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2