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出境医 / 临床实验 / EXALT: EXercise Attenuates Liver Tumors Trial (EXALT)
EXALT: EXercise Attenuates Liver Tumors Trial (EXALT)
Study Description
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.
Study Design
| 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 2022 |
| Estimated Study Completion Date : | June 2023 |
Arms and Interventions
| 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.
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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.
|
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No Intervention: Standard of Care
Subjects are instructed to maintain their current activity level.
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
Eligibility Criteria
| 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
Contacts and Locations
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
| 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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 31, 2019 | ||||||||
| First Posted Date ICMJE | June 7, 2019 | ||||||||
| Last Update Posted Date | February 23, 2021 | ||||||||
| Actual Study Start Date ICMJE | January 3, 2019 | ||||||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | EXALT: EXercise Attenuates Liver Tumors Trial | ||||||||
| Official Title ICMJE | EXALT: EXercise Attenuates Liver Tumors Trial | ||||||||
| 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. | ||||||||
| 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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE | Hepatocellular Carcinoma | ||||||||
| Intervention ICMJE | 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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
21 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 2023 | ||||||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 69 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03979547 | ||||||||
| Other Study ID Numbers ICMJE | STUDY00012527 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Jonathan Stine, Milton S. Hershey Medical Center | ||||||||
| Study Sponsor ICMJE | Milton S. Hershey Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Milton S. Hershey Medical Center | ||||||||
| Verification Date | February 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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