EXALT: EXercise Attenuates Liver Tumors Trial

Hepatocellular Carcinoma Clinical Trial

— EXALT  

Official title:

EXALT: EXercise Attenuates Liver Tumors Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03979547
• Other study ID #: STUDY00012527
• Status: Terminated
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: September 9, 2021

Study information

• Verified date: February 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility-number of participants able to complete the trial	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.	up to 52 weeks
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	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.	up to 52 weeks
Primary	Acceptability-scientifically adequate	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.	up to 52 weeks
Secondary	HCC recurrence		3- and 6- month
Secondary	Overall survival		3- and 6- month
Secondary	Cancer-free survival		3- and 6- month
Secondary	waiting-list mortality		3- and 6- month
Secondary	concentration of IL-6		3- and 6-month
Secondary	visceral adipose tissue (VAT)	change in body composition	3- and 6-month