EXALT: EXercise Attenuates Liver Tumors Trial

Penn State Health

Status: Terminated

Conditions: Hepatocellular Carcinoma

Treatments: Behavioral: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03979547

STUDY00012527

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Exercise intervention

Experimental group

Description:

The exercise program will be similar to the Exercise in All ChemoTherapy (ENACT) study which combines in-person and home-based strength training and aerobic exercise five days a week.

Treatment:

Behavioral: Exercise intervention

Standard of Care

No Intervention group

Description:

Subjects are instructed to maintain their current activity level.