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Gastrointestinal CancerNCT05606848

To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer

A study testing Nutrition Emulsion (TPF-T) and Foods for special medical purposes [FSMP] for patients with tumors in people with Gastrointestinal Cancer, run by Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd at 14 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal cancer 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?
Nutrition Emulsion (TPF-T) and Foods for special medical purposes [FSMP] for patients with tumors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
14 sitesChina
Study dates
30 Nov 2022to Mar 2025
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

  • Agreed to participate in the study with signed ICF;
  • Age 18-75 years;
  • Patient has gastrointestinal cancer confirmed by histological or imagological method and scheduled for resection via open or laparoscopic surgery;
  • Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening;
  • Hemoglobin ≥ 90 g/L
  • Albumin ≥ 2.5 g/dL
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  • BMI ≥18.5 and ≤29 kg/m2;
  • ECOG Performance status 0-2 preoperatively;
  • Expected survival time >6 months.

Who cannot join

  • Contraindication or intolerance against EN, e.g., acute gastrointestinal bleeding, ileus (Grade≥3 NCI-CTCAE v 5.0);
  • Any congenital defect of amino acid or carbohydrate metabolism, such as phenylalaninemia, galactosaemia;
  • Conditions requiring emergency surgery;
  • Conditions other than cancer and surgery that can be associated with loss of body weight e.g. serious active clinical infections (> Grade 2, NCI-CTCAE 5.0), including active tuberculosis, or self-reported HIV infection or active hepatitis B or C;
  • Known treatment refractory metabolic disease (e.g., poorly-controlled diabetes mellitus or fasting blood glucose≥ 10mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis);
  • Cardiac dysfunction (New York Heart Association Functional Class > III);
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  • Severe hepatic dysfunction associated with significant increase of AST or ALT > 5 ULN or bilirubin > 3 ULN;
  • Severe renal dysfunction associated with serum creatinine concentration > 1.5 ULN and/or required dialysis;
  • Active treatment refractory bleeding;
  • Other malignancies in the last 3 years (except for successfully treated in situ basocellular skin or in situ cervical uterine tumours);
  • Known disease that could seriously affect the digestion and absorption of the IMPs;
  • History of drug or alcohol abuse within 6 months prior to screening;
  • Current use of medication or nutritional supplements containing more than 500 mg of EPA+DHA/day or fish oil capsules/ supplements containing more than 500 mg EPA + DHA/day at screening;
  • Current use of muscle growth supporting substances (e.g., anabolics) at screening;
  • Planned chemotherapy, radiotherapy or immunotherapy during the first 12 days following the surgical tumor resection;
  • Transfusion of blood products within 1 week before screening;
  • Known allergy to contents of the study product or control product;
  • Pregnancy or lactation;
  • Participation in another clinical study with an investigational drug, FSMP or an investigational medical device one month prior to start of study or planned participation in another clinical trial as specified before during the course of the study period;
  • Patient who is unable to understand the spoken and written information or not willing or not able to comply with scheduled visits and the requirements of the study protocol;
  • Considered not suitable for study participation by the investigator

Trial locations and contacts

14 sites in 1 country.

Haiwei Li contact

+86 10 56632760

li.haiwei@sspc.com.cn

14 sites in 1 country

China14 sites, 14 recruiting

  • Beijing Hospital

    Beijing, 100730

    Qi An

    Recruiting

  • Beijing Cancer Hospital

    Beijing

    Ziyu Li, 010-88121122

    Recruiting

  • Capital Medical University Affiliated Beijing Shijitan Hospital

    Beijing

    Hanping Shi, Doctor, 010-63925588

    Hanping Shi, Doctor

    Recruiting

  • Peking University People's Hospital

    Beijing

    Bin Liang, 010-88326666

    Recruiting

  • Xiangya Hospital Central South University

    Changsha

    Zhikang Chen, 0731-89753999

    Recruiting

  • The First Affiliated Hospital Of Guangzhou Medical University

    Guangzhou

    Jiongqiang Huang, (8620) 83062114

    Recruiting

  • Nanfang Hospital

    Guanzhou

    Jiang Yu, 020-61641888

    Qing Li

    Recruiting

  • Yunnan Cancer Hospital（The affiliated hospital of Kunming medical university）

    Kunming

    Youguo Dai, 0871-68185656

    Recruiting

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing

    Zhiwei Jiang, 025-86617141

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Yanbing Zhou, 0532-96166

    Recruiting

  • The Fourth Hospital of Hebei Medical University （Hebei Tumor Hospital）

    Shijia Zhuang

    Yong Li, 0311 - 86095588

    Recruiting

  • The First Affiliated Hospital of SOOCHOW University

    Suzhou

    Lei Qin, 0512-65223637

    Li Zhou

    Recruiting

  • The Central Hospital of Wuhan

    Wuhan

    Hui Wang, 027-82811080

    Recruiting

  • Union hospital tongji medical college huazhong university of science and technology

    Wuhan

    Kaixiong Tao, 027-85726114

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Fresubin Support Drink for Enteral Nutrition Support in Perioperative Patients With Gastrointestinal Cancer: A Prospective, Randomized, Open-Label, Active-Controlled Multi-Center Clinical Trial

This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal cancer undergoing surgical resection during the perioperative period.

Read the detailed description

This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. The IMP includes study product and control product. The study product will be Fresubin Support Drink (FSMP), the control product will be Enteral Nutrition Emulsion(TPF-T) . Not exceed 350 patients will be randomly assigned to the Fresubin Support Drink (FSMP) group or Enteral Nutrition Emulsion(TPF-T) group at a ratio of 1:1.

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.

Being tested
Nutrition Emulsion (TPF-T), Foods for special medical purposes [FSMP] for patients with tumors
Medical subject headings
Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition Emulsion (TPF-T)Other

    All patients will be randomized to receive the FSMP or control product.

    • Before the surgery: Patients daily intake control product with recommended energy.
    • 1-8 days after surgery: Patients gradually increase control product intake to reach the recommended energy.

  • Foods for special medical purposes [FSMP] for patients with tumorsOther

    All patients will be randomized to receive the FSMP or control product.

    • Before the surgery: Patients daily intake FSMP with recommended energy.
    • 1-8 days after surgery: Patients gradually increase FSMP intake to reach the recommended energy.
Study groups in NCT05606848
Study groupRoleWhat they receive
Control productActive comparatorNutrition Emulsion (TPF-T) is a tumor-specific enteral nutrition therapy
Receives: Other: Nutrition Emulsion (TPF-T)
Study prodcutExperimentalFoods for special medical purposes [FSMP] for patients with tumors
Receives: Other: Foods for special medical purposes [FSMP] for patients with tumors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum prealbumin

    Measured: from baseline to close out visit (Post-operation Day 5-8)

Secondary outcomes (17)

  1. Change in body weight (%)

    Measured: from baseline to Visit 2（Pre-operation Day 1）, Visit 4（Post-operation Day 5 or 6） and close out visit(Post-operation Day 5-8)

  2. Change in serum prealbumin

    Measured: from baseline to Visit 2（Pre-operation Day 1）, Visit 3（Post-operation Day 1） and Visit 4（Post-operation Day 5 or 6）

  3. Change in serum albumin

    Measured: from baseline to Visit 3（Post-operation Day 1） and close out visit(Post-operation Day 5-8)

  4. Change in BMI

    weight in kilograms, height in meters，weight and height will be combined to report BMI in kg/m^2

    Measured: from baseline to close out visit(Post-operation Day 5-8)

  5. Change in PG-SGA

    Measured: from baseline to Close out Visit(Post-operation Day 5-8)

  6. Change in grip strength

    hand grip strength measured in kg

    Measured: from baseline to Close out Visit(Post-operation Day 5-8)

  7. Change in CRP

    Measured: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)

  8. Change in total lymphocyte count

    Measured: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)

  9. Change in total number of CD4+and CD8+

    Measured: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)

  10. Change in CD4+ % and CD8+%

    the respective percentage of CD4+ T lymphocytes and CD8+ T lymphocytes in total lymphocytes

    Measured: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)

  11. Change in CD4+ T lymphocytes /CD8+ T lymphocytes

    Measured: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)

  12. Change in neutrophil/lymphocyte ratio

    Measured: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)

  13. Change in blood glucose

    Measured: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)

  14. Change in lipids

    Measured: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)

  15. Change in ECOG performance status

    Measured: from baseline to Close out Visit(Post-operation Day 5-8)

  16. All adverse events (AEs), including serious adverse events (SAEs) for assessment of safety and tolerability

    Measured: from baseline to Close out Visit(Post-operation Day 5-8)

  17. Energy intake in kcal / kg BW

    Total volume of IMP consumed

    Measured: from baseline to Close out Visit(Post-operation Day 5-8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2022
  2. Study start30 Nov 2022
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05606848
Sponsor's protocol ID
SUPE-001-CEN
Status last verified
Jun 2024
First submitted
27 Oct 2022
Last updated
1 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition Emulsion (TPF-T) and Foods for special medical purposes [FSMP] for patients with tumors in people with Gastrointestinal Cancer, run by Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd at 14 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 9 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haiwei Li (+86 10 56632760, li.haiwei@sspc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum prealbumin (time frame: from baseline to close out visit (Post-operation Day 5-8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05606848.

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 Jul 2024.

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