Liver NeoplasmsNCT04218253
Clinical Application of Nutrition Support Package Before Hepatectomy
A study testing 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber and Dietary mission in people with Liver Neoplasms and Nutrition Therapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection. Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Neoplasms, Nutrition Therapy, Hepatectomy
- What is being tested?
- 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber and Dietary mission
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 30 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Clinical diagnosis of primary liver cancer (including hepatocellular carcinoma, bile duct carcinoma, and mixed cell carcinoma)
- 2. No contraindications for surgery
- 3. Eastern Cooperative Oncology Group (ECOG) score of preoperative physical state <2 points
- 4. Preoperative liver function score Child-Pugh ≤ 6 points: total bilirubin ≤ 3.0 mg / dl, albumin ≥ 28 g / L, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal
- 5. Voluntarily enter the study and sign the informed consent form, and communicate well with the researcher
Who cannot join
- 1. Patients who took fish oil supplements within 3 weeks before the study began
- 2. Patients with severe nutritional risk: serious nutritional risk should be considered when combining any of the following conditions: weight loss > 10% within 6 months; digital pain score (NRS) score > 5 points; BMI <18.5 kg/m2 (all patients with severe nutritional risk undergo individualized supportive care);
- 3. Patients with malignant tumors in other parts
- 4. Patients who are pregnant or lactating
- 5. Patients with mental and neurological disorders who cannot cooperate with medical staff
- 6. Patients with severe diabetes or poor glycemic control
- 7. Patients cannot tolerate nutritional preparations
- 8. Other circumstances that the researcher considers inappropriate to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University cancer Instituteand Hospital
Tianjin
Kun Wang, 23340123 ext. 1155, lcltjmu507@163.com
About this study
Official title: Clinical Application of Preoperative Nutritional Support Package for Liver Cancer
Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection.
Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.
- Conditions
- Liver Neoplasms, Nutrition Therapy, Hepatectomy
- Being tested
- 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber, Dietary mission
- Keywords
- Nutrition Therapy, Hepatectomy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiberDietary supplement
300 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for Mild malnutrition, or 500 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for moderate to severe malnutrition. The degree of malnutrition is determined by Patient-Generated Subjective Global Assessment (PG-SGA).
Dietary missionBehavioural
Dietary education was conducted according to preoperative nutritional requirements
| Study group | Role | What they receive |
|---|---|---|
| nutritional intervention | Experimental | 300 or 500 calories nutritional support before operation according to the level of malnutrition Receives: Dietary Supplement: 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber; Behavioral: Dietary mission |
| control group | Other | Dietary education was conducted according to preoperative nutritional requirements Receives: Behavioral: Dietary mission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications at 30 days after surgery
Postoperative complications were defined by Clavien-Dindo. Grade 1： Any deviation from the normal postoperative course without the need for pharmacologic treatment or surgical, endoscopic, and radiologic interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgetics, and diuretics, and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.
Grade 2： Requiring pharmacologic treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
Grade 3： Requiring surgical, endoscopic, or radiologic intervention 3a： Intervention not under general anesthesia 3b： Intervention under general anesthesia Grade 4：Life-threatening complication (including CNS complications) requiring IC/ICU management.
4a： Single organ dysfunction (including dialysis) 4b： Multiple organ dysfunction Grade 5： Death as a result of complications
Measured: up to 30 days after surgery
Secondary outcomes (1)
Postoperative hospital stay
from the date of the operation to the date of discharge
Measured: up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Oct 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kun Wang, Doctor, Study chair, Tianjin Medical University cancer Instituteand Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218253
- Sponsor's protocol ID
- 20191226
- Status last verified
- Oct 2019
- First submitted
- 29 Dec 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Preoperative Nutritional Support Package for Liver Cancer
- ClinicalTrials.gov ID
- NCT04218253
- Acronym / sponsor ID
- 20191226
- Conditions
- Liver Neoplasms, Nutrition Therapy, Hepatectomy
- Keywords
- Nutrition Therapy, Hepatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 6 Jan 2020 (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.
Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection.
Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutritional intervention | Experimental | Dietary Supplement: 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber, Behavioral: Dietary mission300 or 500 calories nutritional support before operation according to the level of malnutrition |
| control group | Other | Behavioral: Dietary missionDietary education was conducted according to preoperative nutritional requirements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Clinical diagnosis of primary liver cancer (including hepatocellular carcinoma, bile duct carcinoma, and mixed cell carcinoma)
- 2. No contraindications for surgery
- 3. Eastern Cooperative Oncology Group (ECOG) score of preoperative physical state <2 points
- 4. Preoperative liver function score Child-Pugh ≤ 6 points: total bilirubin ≤ 3.0 mg / dl, albumin ≥ 28 g / L, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal
- 5. Voluntarily enter the study and sign the informed consent form, and communicate well with the researcher
Key exclusion criteria (8 listed)
- 1. Patients who took fish oil supplements within 3 weeks before the study began
- 2. Patients with severe nutritional risk: serious nutritional risk should be considered when combining any of the following conditions: weight loss > 10% within 6 months; digital pain score (NRS) score > 5 points; BMI <18.5 kg/m2 (all patients with severe nutritional risk undergo individualized supportive care);
- 3. Patients with malignant tumors in other parts
- 4. Patients who are pregnant or lactating
- 5. Patients with mental and neurological disorders who cannot cooperate with medical staff
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 |
|---|---|---|
| 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber300 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for Mild malnutrition, or 500 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for moderate to severe malnutrition. The degree of malnutrition is determined by Patient-Generated Subjective Global Assessment (PG-SGA). | Dietary supplement | nutritional intervention |
| Dietary missionDietary education was conducted according to preoperative nutritional requirements | Behavioural | control group, nutritional intervention |
Primary outcome
Incidence of complications at 30 days after surgery
Time frame: up to 30 days after surgery
Postoperative complications were defined by Clavien-Dindo. Grade 1： Any deviation from the normal postoperative course without the need for pharmacologic treatment or surgical, endoscopic, and radiologic interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgetics, and diuretics, and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade 2： Requiring pharmacologic treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade 3： Requiring surgical, endoscopic, or radiologic intervention 3a： Intervention not under general anesthesia 3b： Intervention under general anesthesia Grade 4：Life-threatening complication (including CNS complications) requiring IC/ICU management. 4a： Single organ dysfunction (including dialysis) 4b： Multiple organ dysfunction Grade 5： Death as a result of complications
1 secondary outcome
Postoperative hospital stay
Time frame: up to 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Kun Wang, Doctor study chair
Tianjin Medical University cancer Instituteand Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber and Dietary mission in people with Liver Neoplasms and Nutrition Therapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Jan 2020. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunlei Li, Doctor (18622370261, lcltjmu507@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications at 30 days after surgery (time frame: up to 30 days after surgery). 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 6 Jan 2020.