- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03979547
EXALT: EXercise Attenuates Liver Tumors Trial (EXALT)
February 21, 2022 updated by: Jonathan Stine, Milton S. Hershey Medical Center
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 52 weeks
|
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.
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up to 52 weeks
|
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.
|
up to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HCC recurrence
Time Frame: 3- and 6- month
|
3- and 6- month
|
|
Overall survival
Time Frame: 3- and 6- month
|
3- and 6- month
|
|
Cancer-free survival
Time Frame: 3- and 6- month
|
3- and 6- month
|
|
waiting-list mortality
Time Frame: 3- and 6- month
|
3- and 6- month
|
|
concentration of IL-6
Time Frame: 3- and 6-month
|
3- and 6-month
|
|
visceral adipose tissue (VAT)
Time Frame: 3- and 6-month
|
change in body composition
|
3- and 6-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2019
Primary Completion (Actual)
September 9, 2021
Study Completion (Actual)
September 9, 2021
Study Registration Dates
First Submitted
May 31, 2019
First Submitted That Met QC Criteria
June 5, 2019
First Posted (Actual)
June 7, 2019
Study Record Updates
Last Update Posted (Actual)
March 9, 2022
Last Update Submitted That Met QC Criteria
February 21, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00012527
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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