Clinical trial · Interventional
EXALT: EXercise Attenuates Liver Tumors Trial
NCT03979547CI-TRIAL-00056982EXALTterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment challenges
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise intervention
- description
- 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.
- interventionNames
- Behavioral: Exercise intervention
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Subjects are instructed to maintain their current activity level.
Primary outcomes (3)
- measure
- Feasibility-number of participants able to complete the trial
- timeFrame
- up to 52 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.