Study on the Quality of Life (QoL) After Liver Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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. In adult women, it is the seventh most commonly diagnosed cancer and the sixth leading cause of cancer death. The two main types of liver cancer are hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC). The annual overall incidence is approximately 70 and 2 per 100,000 inhabitants for HCC and MFCCC respectively. To date, liver surgery is the treatment of choice for those patients with resectable disease. For some other patients, with specific tumor features, liver transplantation may be applied with good results. However, still today the proportion of resectable or transplantable 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. In other words, in the actual clinical practice a patient operated for HCC or MFCCC generally does not receive postoperative adjuvant chemotherapy. Another 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. Synchro Levels consists of a supplemental nutritional therapy that has been present on the market for more than 15 years. Some studies reported its safety and efficacy in patients with different advanced solid tumors showing an unexpected rate of partial response. However, very few data are available on its role in improving the patients' performance status and the quality of life. This research project aims to test the role of Synchro Levels in enhancing the functional recovery of patients submitted to hepatectomy for HCC or MFCCC.

Official Title
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Quality of Life After Hepatectomy for Primary Liver Tumors: a Prospective Randomized Clinical Trial on the Role of Supplemental Therapy With Synchrolevels

Conditions
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Hepatocarcinoma, Cholangiocarcinoma, Quality of Life

Intervention / Treatment
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* Dietary Supplement: Synchrolevels


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br> | Dietary Supplement: Synchrolevels<br>* Supplement therapy to model the recovery after liver surgery<br>|
| Placebo Comparator: Control<br> | Dietary Supplement: Synchrolevels<br>* Supplement therapy to model the recovery after liver surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life after liver surgery | 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. | 6 months |