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

NCT05606848 | Recruiting

• 1 other identifier: SUPE-001-CEN
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• Change in serum prealbumin

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

Secondary Outcomes (17)

• Change in body weight (%)

  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)

• Change in serum prealbumin

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

• Change in serum albumin

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

• Change in BMI

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

• Change in PG-SGA

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

Study Arms (2)

Control product

ACTIVE COMPARATOR

Nutrition Emulsion (TPF-T) is a tumor-specific enteral nutrition therapy

Other: Nutrition Emulsion (TPF-T)

Study prodcut

EXPERIMENTAL

Foods for special medical purposes \[FSMP\] for patients with tumors

Other: Foods for special medical purposes [FSMP] for patients with tumors

Interventions

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.

Control product

Foods for special medical purposes [FSMP] for patients with tumors OTHER

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 prodcut

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• BMI ≥18.5 and ≤29 kg/m2;
• ECOG Performance status 0-2 preoperatively;
• Expected survival time \>6 months.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd: lead

Study Sites (14)

Beijing Hospital

Beijing, 100730, China

RECRUITING

Beijing Cancer Hospital

Beijing, China

RECRUITING

Capital Medical University Affiliated Beijing Shijitan Hospital

Beijing, China

RECRUITING

Peking University People's Hospital

Beijing, China

RECRUITING

Xiangya Hospital Central South University

Changsha, China

RECRUITING

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, China

RECRUITING

Nanfang Hospital

Guanzhou, China

RECRUITING

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

Kunming, China

RECRUITING

Jiangsu Province Hospital of Chinese Medicine

Nanjing, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, China

RECRUITING

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

Shijia Zhuang, China

RECRUITING

The First Affiliated Hospital of SOOCHOW University

Suzhou, China

RECRUITING

The Central Hospital of Wuhan

Wuhan, China

RECRUITING

Union hospital tongji medical college huazhong university of science and technology

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Food

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hanping Shi, MD

  Capital Medical University Affiliated Beijing Shijitan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiwei Li

CONTACT

+86 10 56632760; li.haiwei@sspc.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 7, 2022
• Study Start: November 30, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)