HepatocarcinomaNCT05464706
Study on the Quality of Life (QoL) After Liver Surgery
A study testing Synchrolevels in people with Hepatocarcinoma and Cholangiocarcinoma, run by Humanitas Clinical and Research Center at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocarcinoma, Cholangiocarcinoma, Quality of Life
- What is being tested?
- Synchrolevels
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age ≥ 18 years old
- First diagnosis and first hepatectomy for HCC or MFCCC
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life After Hepatectomy for Primary Liver Tumors: a Prospective Randomized Clinical Trial on the Role of Supplemental Therapy With Synchrolevels
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.
Read the 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
- Being tested
- Synchrolevels
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynchrolevelsDietary supplement
Supplement therapy to model the recovery after liver surgery
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Not described Receives: Dietary Supplement: Synchrolevels |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Synchrolevels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jan 2018
- Primary completion1 Apr 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Donadon, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464706
- Sponsor's protocol ID
- QOLILS
- Status last verified
- Aug 2022
- First submitted
- 15 Jul 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Hepatectomy for Primary Liver Tumors: a Prospective Randomized Clinical Trial on the Role of Supplemental Therapy With Synchrolevels
- ClinicalTrials.gov ID
- NCT05464706
- Acronym / sponsor ID
- QOLILS
- Conditions
- Hepatocarcinoma, Cholangiocarcinoma, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Dietary Supplement: Synchrolevels |
| Control | Placebo comparator | Dietary Supplement: Synchrolevels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Age ≥ 18 years old
- First diagnosis and first hepatectomy for HCC or MFCCC
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SynchrolevelsSupplement therapy to model the recovery after liver surgery | Dietary supplement | Control, Interventional |
Primary outcome
Quality of life after liver surgery
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchrolevels in people with Hepatocarcinoma and Cholangiocarcinoma, run by Humanitas Clinical and Research Center at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life after liver surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.