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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05464706
Other study ID # QOLILS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date July 1, 2022

Study information

Verified date August 2022
Source Humanitas Clinical and Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Dietary Supplement:
Synchrolevels
Supplement therapy to model the recovery after liver surgery

Locations

Country Name City State
Italy Humanitas Research Hospital Rozzano Lombardia

Sponsors (1)

Lead Sponsor Collaborator
Humanitas Clinical and Research Center

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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