Clinical trial NCT03979547: EXALT: EXercise Attenuates Liver Tumors Trial
Official title: EXALT: EXercise Attenuates Liver Tumors Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: liver cancer
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility-number of participants able to complete the trial
timeFrame: up to 52 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to 52 weeks
measure: Acceptability-scientifically adequate
timeFrame: up to 52 weeks
Secondary outcomes:
measure: HCC recurrence
timeFrame: 3- and 6- month
measure: Overall survival
timeFrame: 3- and 6- month
measure: Cancer-free survival
timeFrame: 3- and 6- month
measure: waiting-list mortality
timeFrame: 3- and 6- month
measure: concentration of IL-6
timeFrame: 3- and 6-month
measure: visceral adipose tissue (VAT)
timeFrame: 3- and 6-month
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
References: