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

NCT ID: NCT05464706

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-07-01

Brief 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.

Detailed 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.

Conditions

Hepatocarcinoma; Cholangiocarcinoma; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Interventional

Group Type: EXPERIMENTAL

Synchrolevels

Intervention Type: DIETARY_SUPPLEMENT

Supplement therapy to model the recovery after liver surgery

Control

Group Type: PLACEBO_COMPARATOR

Synchrolevels

Intervention Type: DIETARY_SUPPLEMENT

Supplement therapy to model the recovery after liver surgery

Interventions

Synchrolevels

Supplement therapy to model the recovery after liver surgery

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Humanitas Clinical and Research Center

OTHER

Sponsor Role: lead

Responsible Party

Matteo Donadon

Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Humanitas Research Hospital

Rozzano, Lombardy, Italy

Countries

Italy

Other Identifiers

QOLILS

Identifier Type: -

Identifier Source: org_study_id