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
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Behavioral: Exercise intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|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)|
|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|
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.
- 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.
- 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.
- 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.
- HCC recurrence [ Time Frame: 3- and 6- month ]
- Overall survival [ Time Frame: 3- and 6- month ]
- Cancer-free survival [ Time Frame: 3- and 6- month ]
- waiting-list mortality [ Time Frame: 3- and 6- month ]
- concentration of IL-6 [ Time Frame: 3- and 6-month ]
- visceral adipose tissue (VAT) [ Time Frame: 3- and 6-month ]change in body composition
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
|Contact: Jonathan G Stine, MD||(717) email@example.com|
|Contact: Gloriany Rivas, BA||(717) 531-0003 ext firstname.lastname@example.org|
|United States, Pennsylvania|
|Penn State Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Gloriany Rivas, BA 717-531-0003 ext 320223 email@example.com|