Tokyo, Aug. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058730) titled 'A study to examine the safety and tolerability of a home-based exercise program after local therapy for liver cancer' on Aug. 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Keio University
Condition:
Condition - Patients with liver cancer who underwent local therapy, aged 18 years or older, with a performance status (PS) of 0 or 1
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the tolerability, safety, and preliminary efficacy of a home-based exercise program in patients discharged after local therapy for liver cancer in a prospective study.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - A 12-week home-based exercise program will be provided to patients aged 18 years or older who have been discharged after local therapy for liver cancer. The program includes resistance training using a theraband targeting three lower limb muscle groups (iliopsoas, quadriceps, gluteus medius) at least 3 days per week, and aerobic exercise in the form of walking. The step count target will start at 3,000 steps per day and increase by 1,000 steps every month. A pedometer and smartphone application will be used to monitor and record adherence.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients who have undergone local therapy for hepatocellular carcinoma (microwave ablation or transarterial chemoembolization)
Written informed consent obtained
Aged 18 to 80 years
Performance status of 0 or 1
Preserved organ function
Able to attend outpatient visits
Key exclusion criteria - Serious systemic infections or fever >= 38 degrees Celsius
Pregnant, possibly pregnant, or breastfeeding women
Psychiatric illness or symptoms interfering with participation
Ongoing systemic steroid therapy
Uncontrolled diabetes (HbA1c >= 8%) or hypertension
Unstable angina or myocardial infarction within 6 months
Interstitial pneumonia, pulmonary fibrosis, severe emphysema, or acute heart failure
History of cerebrovascular disease within 6 months
Any condition deemed inappropriate by the attending physician
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 01 Day
Date of IRB - 2025 Year 08 Month 01 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067156
Disclaimer: Curated by HT Syndication.