The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06047158
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of Qingdao University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Fish Oils Perfusion; Complications Stomach Neoplasms Nutrition Aspect of Cancer Chemotherapy Effect Immunisation Reaction Drug: Omega-3 fish oil fat emulsion

Detailed Description:

The research process is as follows:

  1. Select patients in the group according to the inclusion and exclusion criteria.
  2. The patient signed the informed consent form
  3. His system was used to collect patient data, including human-related baseline data, including sex, age, BMI, ASA grade, tumor location, histological grade, pathological tumor type, pTNM stage (AJCC cancer stage 8th edition), lymphatic 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.
  4. Using statistical software (SPSS) to judge the statistical difference.
  5. It is concluded that the use value of omega-3 fish oil fat emulsion (Ewing) is evaluated.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : December 1, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
Use 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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immune related index [ Time Frame: one week ]
    Peripheral blood lymphocyte count

  2. Immune related index [ Time Frame: one week ]
    Plasma albumin concentration

  3. Immune related index [ Time Frame: one week ]
    C-reactive protein concentration

  4. Immune related index [ Time Frame: one week ]
    Postoperative infectious complications


Secondary Outcome Measures :
  1. Hospitalization related [ Time Frame: From the first day after operation to discharge, up to 30 days. ]
    Hospitalization time

  2. Hospitalization related [ Time Frame: From the first day after operation to discharge, up to 30 days. ]
    Hospitalization expenses


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06047158


Contacts
Layout table for location contacts
Contact: Liu Ruiqing, Doctor 18661809036 liuruiqing@smail.nju.edu.cn

Locations
Layout table for location information
China, Shan Dong
Ruiqing Liu Recruiting
Qingdao, Shan Dong, China, 266003
Contact: Wang Dongsheng, Doctor    18661807896    wangds0538@hotmail.com   
Sponsors and Collaborators
The Affiliated Hospital of Qingdao University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT06047158    
Other Study ID Numbers: RCEOFOITP
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases