Hepatocellular CarcinomaNCT04649671
The Effect of Mobile Health-based Exercise on Hepatocellular Carcinoma Patients With Insulin Resistance
A study testing Mobile health in people with Hepatocellular Carcinoma and Insulin Resistance, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Insulin Resistance
- What is being tested?
- Mobile health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2021to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobile Health-based Exercise on Insulin Sensitivity in Hepatocellular Carcinoma Patients With Insulin Resistance: A Randomized Controlled Trial
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.
- Conditions
- Hepatocellular Carcinoma, Insulin Resistance
- Being tested
- Mobile health
- Medical subject headings
- Carcinoma, Hepatocellular, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile healthBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Hepatocellular carcinoma (HCC) patients with insulin resistance who underwent hepatic resection or radiofrequency ablation (RFA) will be enrolled. Patients included in the control arm will receive a booklet including information about physical activity recommendations and practice (education). After 12 weeks, they will also be provided mobile application and wearable device and perform exercise for 12 weeks. |
| Mobile health | Active comparator | HCC patients with insulin resistance who underwent hepatic resection or RFA will be enrolled. Patients included in the intervention arm will receive both booklet and mobile health program. They will perform exercise daily with mobile application and wearable device (warm-up, stretching, aerobic, and strengthening) for 24 weeks. Receives: Behavioral: Mobile health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of insulin resistance
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)
Measured: After 12 weeks
Secondary outcomes (8)
Improvement of insulin resistance
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)
Measured: After 24 weeks
Improvement of 6-minute walk test
- Changes in meters assessed using the 6-minute walk test
Measured: After 12 and 24 weeks
Improvement of grip strength test
- Changes in kilograms assessed using grip strength test
Measured: After 12 and 24 weeks
Improvement of 30-second chair stand test
- Changes in seconds assessed using 30-second chair stand test
Measured: After 12 and 24 weeks
Improvement of the score of International Physical Activity Questionnaire-Short Form (IPAQ-SF)
- Changes in metabolic equivalents (METs) per week calculated using IPAQ-SF
Measured: After 12 and 24 weeks
Improvement of quality of life
Improved score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30
Measured: After 12 and 24 weeks
Nutritional status
Comparison of nutrition score using mini nutritional assessment
Measured: After 12 and 24 weeks
Adverse events
Any adverse events occurred during exercise
Measured: After 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start2 Mar 2021
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Why it stopped: Difficulty in recruitment and deficit of research fund
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moon Seok Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649671
- Sponsor's protocol ID
- SMC2020-06-037
- Status last verified
- Mar 2023
- First submitted
- 17 Nov 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yeo SM, Oh JH, Yu HJ, Sinn DH, Hwang JH. The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial. Trials. 2022 Nov 8;23(1):930. doi: 10.1186/s13063-022-06858-w.
PubMed 36348422
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Health-based Exercise on Insulin Sensitivity in Hepatocellular Carcinoma Patients With Insulin Resistance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04649671
- Acronym / sponsor ID
- SMC2020-06-037
- Conditions
- Hepatocellular Carcinoma, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment and deficit of research fund
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Hepatocellular carcinoma (HCC) patients with insulin resistance who underwent hepatic resection or radiofrequency ablation (RFA) will be enrolled. Patients included in the control arm will receive a booklet including information about physical activity recommendations and practice (education). After 12 weeks, they will also be provided mobile application and wearable device and perform exercise for 12 weeks. |
| Mobile health | Active comparator | Behavioral: Mobile healthHCC patients with insulin resistance who underwent hepatic resection or RFA will be enrolled. Patients included in the intervention arm will receive both booklet and mobile health program. They will perform exercise daily with mobile application and wearable device (warm-up, stretching, aerobic, and strengthening) for 24 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile healthPerform exercise daily with mobile application and wearable device (warm-up, stretching, aerobic, and strengthening). Mobile application: Hepatocellular carcinoma by Second Doctor Wearable device: Dofit | Behavioural | Mobile health |
Primary outcome
Improvement of insulin resistance
Time frame: After 12 weeks
The proportion of normalization of homeostatic model assessment of insulin resistance (HOMA-IR) (<2.2)
8 secondary outcomes
Improvement of insulin resistance
Time frame: After 24 weeks
Improvement of 6-minute walk test
Time frame: After 12 and 24 weeks
Improvement of grip strength test
Time frame: After 12 and 24 weeks
Improvement of 30-second chair stand test
Time frame: After 12 and 24 weeks
Improvement of the score of International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: After 12 and 24 weeks
Improvement of quality of life
Time frame: After 12 and 24 weeks
Nutritional status
Time frame: After 12 and 24 weeks
Adverse events
Time frame: After 12 and 24 weeks
Results and safety
The study was stopped early (reason given: Difficulty in recruitment and deficit of research fund). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 36348422Yeo SM, Oh JH, Yu HJ, Sinn DH, Hwang JH. The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial. Trials. 2022 Nov 8;23(1):930. doi: 10.1186/s13063-022-06858-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health in people with Hepatocellular Carcinoma and Insulin Resistance, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruitment and deficit of research fund). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of insulin resistance (time frame: After 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04649671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.