Effects of Omega-3 Fish Oil Fat Emulsion on Rehabilitation and Immune Function After Radical Surgery Combined With Intraperitoneal Hyperthermic Infusion Chemotherapy in Patients With Locally Advanced Gastric Cancer

NCT06047158 | Unknown

• 1 other identifier: RCEOFOITP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the effects of omega-3 fish oil fat emulsion on peripheral blood C-reactive protein, total lymphocyte count, plasma albumin and immune function after radical surgery combined with intraperitoneal hyperthermic perfusion chemotherapy in patients with locally advanced gastric cancer. at the same time, to explore the effects of omega-3 fish oil fat emulsion on complications, length of stay and total cost of hospitalization. The main question it aims to answer is whether the use of omega-3 fish oil fat emulsion can improve patients' immunity, speed up recovery and reduce costs. Participants will comprehensively collect patient-related baseline data, including sex, age, BMI, ASA grade, tumor location, histological grade, pathological tumor type, pTNM stage (AJCC cancer stage 8), and perilymphatic vascular / nerve infiltration. Immune function evaluation related index: peripheral blood lymphocyte count. Plasma albumin concentration, C-reactive protein, postoperative infectious complications, length of stay and cost of hospitalization. Finally, statistical analysis software was used to analyze the differences between the two groups, evaluate the above indicators and draw mutual conclusions.

Conditions

Fish Oils; Perfusion; Complications; Stomach Neoplasms; Nutrition Aspect of Cancer; Chemotherapy Effect; Immunisation Reaction

Outcome Measures

Primary Outcomes (4)

• Immune related index

  Peripheral blood lymphocyte count

  one week

• Immune related index

  Plasma albumin concentration

  one week

• Immune related index

  C-reactive protein concentration

  one week

• Immune related index

  Postoperative infectious complications

  one week

Secondary Outcomes (2)

• Hospitalization related

  From the first day after operation to discharge, up to 30 days.

• Hospitalization related

  From the first day after operation to discharge, up to 30 days.

Study Arms (2)

Fish oil group

The patients in this group were treated with omega-3 fish oil fat emulsion at a dose of 100ml/ per person per day for 5 days and added to a three-liter bag (containing water, glucose, amino acids, sodium chloride, vitamins, etc.) except fish oil. Drug introduction: Full name: omega-3 fish oil fat emulsion. Common name: Juventus. Specification: 100ml / 10g

Drug: Omega-3 fish oil fat emulsion

Non-fish oil group

Do not use omega-3 fish oil fat emulsion (no omega-3 fish oil fat emulsion is added to the three-liter bag, other substances are the same)

Interventions

Omega-3 fish oil fat emulsion DRUG

Use omega-3 fish oil fat emulsion

Fish oil group

Eligibility Criteria

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

Study Population

The study population were patients with advanced gastric cancer who had received surgical treatment. According to the wishes of the patients, they chose whether to use omega-3 fish oil fat emulsion and were assigned to different groups to observe the effect.

You may qualify if:

• The age is 18 to 75 years old.
• For advanced gastric cancer, according to the TNM staging specified by the 8th edition AJCC, the clinical staging or EUS staging is above T2. There is no distant metastasis before operation, and the tumor does not directly invade the surrounding organs (liver, pancreas, spleen and transverse mesocolon, etc.).
• There is no obvious contraindication to surgery.
• The preoperative physical status score of Eastern American Cancer Cooperation (ECOG) was 0 or 1.
• The preoperative ASA grade was grade Ⅰ-Ⅲ.
• No previous history of gastric surgery, no history of other malignant tumors.
• After explaining the nature and purpose of the study, agree to sign an informed consent form, give voluntary consent to participate in the study, and comply with the requirements of the study.

You may not qualify if:

• Radiotherapy or chemotherapy before operation.
• Use of immunosuppressants such as hormones within 3 months before treatment.
• Preoperative anemia (hemoglobin \< 90g/L) and severe hypoalbuminemia (albumin \< 30g/L).
• With severe heart and lung and other important organ dysfunction.
• More serious metabolic and immune diseases, such as hyperthyroidism, poor blood glucose control in diabetes, obesity, hyperlipidemia (triglyceride \> 3mmol/L, total bile solid \> 6.2mmol/L).
• Severe infection before operation.
• With complete intestinal obstruction, intestinal perforation and intestinal necrosis.
• During the operation, it was found that radical operation could not be performed or combined organ resection was needed.
• Operation time \> 6 hours, intraoperative bleeding \> 400ml

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Ruiqing Liu

Qingdao, Shandong, 266003, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Liu Ruiqing, Doctor

CONTACT

18661809036; liuruiqing@smail.nju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 21, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)