Clinical trial · Interventional
Study on the Quality of Life (QoL) After Liver Surgery
Quality of Life After Hepatectomy for Primary Liver Tumors: a Prospective Randomized Clinical Trial on the Role of Supplemental Therapy With Synchrolevels
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Liver cancer in adult men is the fifth most frequently diagnosed cancer worldwide, and is the second leading cause of cancer-related death in the world. To date, liver surgery is the treatment of choice for those patients with resectable disease. However, still today the proportion of resectable patients is limited due to a large proportion of patients presenting with advances disease. For these patients, the treatment consists of systemic chemotherapy, which unfortunately is associated with median survival of 12 months. The choice of the appropriate treatment scheme adheres to the standard guidelines based on the results of clinical trials. Of note, in case of HCC and MFCCC very few international approved therapeutic guidelines are available. In particular, there is no agreement among specialists about the use of chemotherapy as adjuvant treatment after hepatic resection for HCC or MFCCC. An important aspect of the postoperative "adjuvant therapy" is the possibility to enhance the recovery after the operation. Indeed, the possibility to accelerate the functional recovery in a patient who receives a major cancer operation is of paramount importance. In this sense, having a product that might help the patients' recovery should be one of the priorities of the medical and pharmaceutical industry. To our knowledge, there are no previous studies that investigated such an important aspect.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocarcinoma | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Synchrolevels | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional
- interventionNames
- Dietary Supplement: Synchrolevels
- type
- PLACEBO_COMPARATOR
- label
- Control
- interventionNames
- Dietary Supplement: Synchrolevels
Primary outcomes (1)
- measure
- Quality of life after liver surgery
- timeFrame
- 6 months
- description
- Quality of life (recovery after liver surgery) measured by using the European form SF36. The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It comprises 36 questions which cover eight domains of health.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Age ≥ 18 years old * First diagnosis and first hepatectomy for HCC or MFCCC Exclusion Criteria: * Refute to sign the informed consent * Age \< 18 years old * Indication to perform adjuvant (postoperative) chemotherapy * Any psychological or psychiatric condition that might compromise the patients' compliance.
References
Publications (0)
Data not yet available