EXALT: EXercise Attenuates Liver Tumors Trial

NCT03979547 | Terminated DMC

• 1 other identifier: STUDY00012527
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

liver cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• HCC recurrence

  3- and 6- month

• Overall survival

  3- and 6- month

• Cancer-free survival

  3- and 6- month

• waiting-list mortality

  3- and 6- month

• concentration of IL-6

  3- and 6-month

Study Arms (2)

Exercise intervention

EXPERIMENTAL

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.

Behavioral: Exercise intervention

Standard of Care

NO INTERVENTION

Subjects are instructed to maintain their current activity level.

Interventions

Exercise intervention 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.

Exercise intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 7, 2019
• Study Start: January 3, 2019
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

US (1)