Gastrointestinal CancerNCT05301556
Food for Special Medical Purpose in Patients With Digestive Tract Tumor
A study testing Experimental Product in people with Gastrointestinal Cancer, run by Abbott Nutrition at 8 sites in China.
Trial summary
This is a prospective, randomized, controlled, unblinded, parallel, multicenter, and non-inferiority study to demonstrate the safety and efficacy of a Food for Special Medical Purpose product (FSMP) in participants with digestive tract tumor undergoing surgical resection during the perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Experimental Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 8 sitesChina
- Study dates
- 24 Jun 2022to 9 Jan 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is male or female, between 18 and 75 years old, female participant is non-pregnant or non- lactating, at least 6 weeks postpartum
- Participants with digestive tract tumors diagnosed by histological method or radiological diagnosis and scheduled to undergo surgical resection
- Participant with NRS-2002 score ≥3
- Participant is willing to comply with the study protocol, able and willing to consume study product according to the protocol
- Participants with Body Mass Index 18.5 - 30 kg/m2
- Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study
Who cannot join
- Participant has an expected life expectancy < 3 months
- Participant has contraindications to enteral nutrition (such as active gastrointestinal hemorrhage, bowel obstruction, decompensated short bowel syndrome, high flow intestinal fistula, severe intraperitoneal infection, severe gastrointestinal emptying disorder, unstable vital signs, dyscoagulation, severe nausea, vomiting and/or uncontrolled diarrhea/steatorrhoea) that in the opinion of the study physician cannot be corrected
- Participant used parenteral nutrition or had plasma infused, RBC infused, albumin infused, amino acid infused or undergone radiotherapy and/or chemotherapy within 1 week before screening
- Participant with serum Albumin <2.5g/dl at the time of the screening
- Participant has moderate to severe anemia, i.e. Hgb < 90g / L
- Patients who plan to receive endoscopic tumor resection or / and palliative surgery
Show all 21Show fewer
- Participant has renal dysfunction (serum creatinine > 2 times the upper limit of normal (ULN))
- Participant has liver insufficiency [serum alanine transaminase (ALT) and/or aspartate transaminase (AST) > 2 times the ULN or severe cholestasis (conjugated bilirubin > 2 times the ULN)]
- Participant has severe cardiac insufficiency (e.g., Severe arrhythmia or atrial fibrillation; myocardial ischemia or stent surgery with unstable cardiac function within 3 months prior to screening visit )
- Participant states that he/she has had a significant cardiovascular and cerebrovascular event (e.g., myocardial infarction, stroke) within six months prior to screening visit; or stated history of congestive heart failure
- Participant with type I diabetes, or type II diabetes with fasting blood glucose ≥8mmol/L
- Participant has history of significant neurological or psychiatric disorder
- Participant has history of alcoholism, drug abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- Participant has a known history of allergy or intolerance to any ingredient in the investigational products
- Participant is currently undergoing tumor immunotherapy taking medications/substances that could profoundly modulate appetite, metabolism or inflammatory level
- Appetite enhancers, pregnancy promoters, steroids (nasal inhalation, topical and optical steroids are acceptable);
- Anti-inflammatory fat emulsions or other oral nutritional supplementations/drugs containing Omega-3 fatty acids, protein, glutamine, or arginine.
- Dexamethasone, growth hormone or other drugs affecting metabolism;
- Participant is currently undergoing tumor immunotherapy or taking medications/substances that could profoundly modulate immune function, such as PD1 or PDL1 inhibitors; CTLA-4 inhibitor; Thymosin; Azathioprine; Cyclosporine; Tacrolimus; Tumor necrosis factor antagonist; Lentinan; immune-modulating Chinese medicine
- Participant with active tuberculosis and HIV infection
- Participant participated in any clinical trial within four weeks prior to the screening visit.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Hospital
Beijing, 100005
Peking Union Medical College Hospital
Beijing, 100005
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
Peking University People's Hospital
Beijing, 100044
Beijing Cancer Hospital
Beijing, 100142
Beijing Tsinghua Changgung Hospital
Beijing, 102218
The Six Afffilated Hospital Sun Yat-sen University
Guangzhou, 510665
The Affiliated Hospital of Qingdao University
Qingdao, 266003
About this study
Official title: Effect of a Food for Special Medical Purpose (FSMP) Product During the Perioperative Period in Patients With Digestive Tract Tumor
This is a prospective, randomized, controlled, unblinded, parallel, multicenter, and non-inferiority study to demonstrate the safety and efficacy of a Food for Special Medical Purpose product (FSMP) in participants with digestive tract tumor undergoing surgical resection during the perioperative period.
Read the detailed description
This is a prospective, randomized, controlled, unblinded, parallel, and multicenter, and non-inferiority study to demonstrate the safety and efficacy of a FSMP in participants with digestive tract tumor undergoing surgical resection during the perioperative period. Half of the participants will receive FSMP, the other half will receive Enteral Nutrition Emulsion (TPF-T) as an active control.
Prealbumin, albumin, C-reactive protein (CRP), immunology parameters, vital signs, nutrition and safety-related laboratory parameters, compliance, and Adverse Events (AEs) will be evaluated in this study, to demonstrate its parity with TPF-T on efficacy and safety.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Experimental Product, Control Product
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ProductOther
- Before the surgery: FSMP provides daily target energy needed by participants
- 1-2 days after surgery: Start FSMP and advance as tolerated to achieve 20% of the daily target energy needed by participants
- 3rd-5th day after surgery: Gradually increase FSMP intake every day as tolerated to provide 30-80% of the daily target energy needed by participants
- 6th to 11th day after surgery. FSMP provides daily target energy needed by participants
Control ProductOther
- Before surgery: TPF-T provides daily target energy needed by participants
- 1-2 days after surgery: Start TPF-T and advance as tolerated to achieve 20% of the daily target energy needed by participants
- 3rd-5th day after surgery: Gradually increase TPF-T intake every day as tolerated to provide 30-80% of the daily target energy needed by participants
- 6th to 11th day after surgery. TPF-T provides daily target energy needed by participants
| Study group | Role | What they receive |
|---|---|---|
| Experimental Product | Experimental | Food for Special Medical Purpose (FSMP) is a special medical food for patients with tumors Receives: Other: Experimental Product |
| Control Product | Active comparator | Nutrition Emulsion (TPF-T) TPF-T is a tumor-specific enteral nutrition therapy Receives: Other: Control Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Pre-Albumin
Change in pre-albumin
Measured: Baseline to Post Op Day (POD) 9
Secondary outcomes (3)
Serum Albumin
Change in albumin
Measured: Baseline to Post Op Day (POD) 9
Weight
Change in weight
Measured: Baseline to Post Op Day (POD) 9
Nutritional Risk Screening (NRS) 2002
NRS-2002 scored from 0 Low Risk to 7 High Risk
Measured: Baseline to Post Op Day (POD) 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start24 Jun 2022
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shengqi Li, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301556
- Sponsor's protocol ID
- BL43
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2022
- Last updated
- 1 Mar 2024
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Food for Special Medical Purpose (FSMP) Product During the Perioperative Period in Patients With Digestive Tract Tumor
- ClinicalTrials.gov ID
- NCT05301556
- Acronym / sponsor ID
- BL43
- Conditions
- Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 29 Mar 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.
This is a prospective, randomized, controlled, unblinded, parallel, multicenter, and non-inferiority study to demonstrate the safety and efficacy of a Food for Special Medical Purpose product (FSMP) in participants with digestive tract tumor undergoing surgical resection during the perioperative period.
Detailed description
This is a prospective, randomized, controlled, unblinded, parallel, and multicenter, and non-inferiority study to demonstrate the safety and efficacy of a FSMP in participants with digestive tract tumor undergoing surgical resection during the perioperative period. Half of the participants will receive FSMP, the other half will receive Enteral Nutrition Emulsion (TPF-T) as an active control.
Prealbumin, albumin, C-reactive protein (CRP), immunology parameters, vital signs, nutrition and safety-related laboratory parameters, compliance, and Adverse Events (AEs) will be evaluated in this study, to demonstrate its parity with TPF-T on efficacy and safety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Product | Experimental | Other: Experimental ProductFood for Special Medical Purpose (FSMP) is a special medical food for patients with tumors |
| Control Product | Active comparator | Other: Control ProductNutrition Emulsion (TPF-T) TPF-T is a tumor-specific enteral nutrition therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is male or female, between 18 and 75 years old, female participant is non-pregnant or non- lactating, at least 6 weeks postpartum
- Participants with digestive tract tumors diagnosed by histological method or radiological diagnosis and scheduled to undergo surgical resection
- Participant with NRS-2002 score ≥3
- Participant is willing to comply with the study protocol, able and willing to consume study product according to the protocol
- Participants with Body Mass Index 18.5 - 30 kg/m2
Key exclusion criteria (21 listed)
- Participant has an expected life expectancy < 3 months
- Participant has contraindications to enteral nutrition (such as active gastrointestinal hemorrhage, bowel obstruction, decompensated short bowel syndrome, high flow intestinal fistula, severe intraperitoneal infection, severe gastrointestinal emptying disorder, unstable vital signs, dyscoagulation, severe nausea, vomiting and/or uncontrolled diarrhea/steatorrhoea) that in the opinion of the study physician cannot be corrected
- Participant used parenteral nutrition or had plasma infused, RBC infused, albumin infused, amino acid infused or undergone radiotherapy and/or chemotherapy within 1 week before screening
- Participant with serum Albumin <2.5g/dl at the time of the screening
- Participant has moderate to severe anemia, i.e. Hgb < 90g / L
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 |
|---|---|---|
| Experimental Product* Before the surgery: FSMP provides daily target energy needed by participants * 1-2 days after surgery: Start FSMP and advance as tolerated to achieve 20% of the daily target energy needed by participants * 3rd-5th day after surgery: Gradually increase FSMP intake every day as tolerated to provide 30-80% of the daily target energy needed by participants * 6th to 11th day after surgery. FSMP provides daily target energy needed by participants | Other | Experimental Product |
| Control Product* Before surgery: TPF-T provides daily target energy needed by participants * 1-2 days after surgery: Start TPF-T and advance as tolerated to achieve 20% of the daily target energy needed by participants * 3rd-5th day after surgery: Gradually increase TPF-T intake every day as tolerated to provide 30-80% of the daily target energy needed by participants * 6th to 11th day after surgery. TPF-T provides daily target energy needed by participants | Other | Control Product |
Primary outcome
Serum Pre-Albumin
Time frame: Baseline to Post Op Day (POD) 9
Change in pre-albumin
3 secondary outcomes
Serum Albumin
Time frame: Baseline to Post Op Day (POD) 9
Weight
Time frame: Baseline to Post Op Day (POD) 9
Nutritional Risk Screening (NRS) 2002
Time frame: Baseline to Post Op Day (POD) 9
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 1 Mar 2024.
- 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.
Shengqi Li, PhD study chair
Abbott Nutrition
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Product in people with Gastrointestinal Cancer, run by Abbott Nutrition at 8 sites 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 6 inclusion and 21 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
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?
Serum Pre-Albumin (time frame: Baseline to Post Op Day (POD) 9). 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 1 Mar 2024.