Hepatocellular Carcinoma
Conditions
Keywords
liver cancer
Brief summary
The overall goal of this proposal is to test the effect of exercise to delay or avert HCC recurrence and gain information regarding the potential molecular mechanisms of HCC tumor inhibition by exercise.
Detailed description
Primary liver cancer is the leading cause of cancer worldwide. The majority of primary liver cancers are hepatocellular carcinoma (HCC) and occur in the setting of cirrhosis of the liver. Body fat and systemic inflammation are determinants of HCC risk. Cirrhotic patients with HCC are often treated with locoregional therapies including transarterial chemoembolization (TACE) as a bridge to liver transplantation. Despite this, HCC recurrence rates approach 80%. There is a growing body of evidence to suggest the benefit of exercise in cancer patients. Exercise decreases disease recurrence and improves survival in other primary cancers by altering tumor biology and influencing response to treatment. Although animal models suggest biologic plausibility, whether or not exercise prevents HCC recurrence in cancer patients remains unknown. The overall goal of this proposal is to test the effect of exercise to delay or avert HCC recurrence and gain information regarding the potential molecular mechanisms of HCC tumor inhibition by exercise.
Interventions
BEHAVIORALExercise intervention
Moving Through Cancer: A Guide to Exercise for Cancer Survivors will serve as the framework for an American College of Sports Medicine certified exercise physiologist with additional Cancer Exercise training to teach proper warm up, use of equipment, exercise form, mode of activity, intensity of exercise, flexibility exercises, and cool down.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
perform an interventional pilot trial and randomize 21 subjects who have had a complete response to TACE to a 3-month exercise intervention (n=14) versus standard of care (n=7) where subjects are instructed to maintain their current activity level.
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Adults age \>=18 or \<70 years * Liver transplant candidates (under evaluation or listed for transplant with HCC) * Hepatocellular Carcinoma diagnosis (HCC) * Complete response to LRT
Exclusion criteria
* Active cardiac symptoms * BMI \<18 or \>45 kg/m2(16) * CPT Class B or C liver disease * ECOG \>2 * Hepatic decompensation * Institutionalized/prisoner * Pregnancy * Severe medical comorbidities/psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility-number of participants able to complete the trial | up to 52 weeks | Defined as completing \>80% of the sessions.(46, 47) While this would be expected for patients with cirrhosis,(46) this would be five-fold larger than the proportion of oncology patients receiving systemic treatment who complete other exercise based randomized controlled trials. We expect exercise in subjects with HCC in the background of Child Pugh Turcotte (CPT) Class A cirrhosis without hepatic decompensation (e.g., ascites, hepatic encephalopathy, bleeding gastroesophageal varices) and Eastern Cooperative Oncology Group (ECOG) 0-2 functional status to be feasible. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 52 weeks | Data from previous oncology trials suggest up to 25% of the participants may experience a mild musculoskeletal impairment and zero adverse effects requiring treatment alterations. Pilot exercise-based trials in patients with cirrhosis have demonstrated \<5% adverse events. |
| Acceptability-scientifically adequate | up to 52 weeks | To assess the effectiveness of exercise trials in patients with HCC. The work with the ongoing NASHFit and completed ENACT Trials and the work of others performing exercise-based trials in patients with cirrhosis(50) has established \>50% enrollment of subjects approached as a threshold of acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCC recurrence | 3- and 6- month | — |
| Overall survival | 3- and 6- month | — |
| Cancer-free survival | 3- and 6- month | — |
| waiting-list mortality | 3- and 6- month | — |
| concentration of IL-6 | 3- and 6-month | — |
| visceral adipose tissue (VAT) | 3- and 6-month | change in body composition |
Countries
United States
Outcome results
None listed