EXALT: EXercise Attenuates Liver Tumors Trial

Not Applicable

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Behavioral: Exercise intervention

• Registration Number: NCT03979547
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study Start: 2019-01-03
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-07
• Primary Completion: 2021-09-09
• Study Completion: 2021-09-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise intervention	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
HCC recurrence	3- and 6- month
visceral adipose tissue (VAT)	3- and 6-month	change in body composition
concentration of IL-6	3- and 6-month
Overall survival	3- and 6- month
waiting-list mortality	3- and 6- month
Cancer-free survival	3- and 6- month

Trial Locations

Locations (1)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States