EXALT: EXercise Attenuates Liver Tumors Trial

NCT ID: NCT03979547

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2021-09-09

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise intervention

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.

Group Type: EXPERIMENTAL

Exercise intervention

Intervention Type: BEHAVIORAL

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.

Standard of Care

Subjects are instructed to maintain their current activity level.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Stine

Assistant Professor Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00012527

Identifier Type: -

Identifier Source: org_study_id