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.
