Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

EXALT: EXercise Attenuates Liver Tumors Trial (EXALT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979547
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan Stine, 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Behavioral: Exercise intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EXALT: EXercise Attenuates Liver Tumors Trial
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Standard of Care
Subjects are instructed to maintain their current activity level.



Primary Outcome Measures :
  1. Feasibility-number of participants able to complete the trial [ Time Frame: 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.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 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.

  3. Acceptability-scientifically adequate [ Time Frame: 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.


Secondary Outcome Measures :
  1. HCC recurrence [ Time Frame: 3- and 6- month ]
  2. Overall survival [ Time Frame: 3- and 6- month ]
  3. Cancer-free survival [ Time Frame: 3- and 6- month ]
  4. waiting-list mortality [ Time Frame: 3- and 6- month ]
  5. concentration of IL-6 [ Time Frame: 3- and 6-month ]
  6. visceral adipose tissue (VAT) [ Time Frame: 3- and 6-month ]
    change in body composition



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979547


Contacts
Layout table for location contacts
Contact: Jonathan G Stine, MD (717) 531-1017 jstine@pennstatehealth.psu.edu
Contact: Gloriany Rivas, BA (717) 531-0003 ext 320223 grivas@pennstatehealth.psu.edu

Locations
Layout table for location information
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Gloriany Rivas, BA    717-531-0003 ext 320223    grivas@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center

Layout table for additonal information
Responsible Party: Jonathan Stine, Assistant Professor Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03979547    
Other Study ID Numbers: STUDY00012527
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Stine, Milton S. Hershey Medical Center:
liver cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases