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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

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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

Tracking Information
First Submitted Date September 4, 2023
First Posted Date September 21, 2023
Last Update Posted Date September 21, 2023
Actual Study Start Date December 1, 2022
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 14, 2023)
  • Immune related index [ Time Frame: one week ]
    Peripheral blood lymphocyte count
  • Immune related index [ Time Frame: one week ]
    Plasma albumin concentration
  • Immune related index [ Time Frame: one week ]
    C-reactive protein concentration
  • Immune related index [ Time Frame: one week ]
    Postoperative infectious complications
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 14, 2023)
  • Hospitalization related [ Time Frame: From the first day after operation to discharge, up to 30 days. ]
    Hospitalization time
  • Hospitalization related [ Time Frame: From the first day after operation to discharge, up to 30 days. ]
    Hospitalization expenses
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Fish Oils
  • Perfusion; Complications
  • Stomach Neoplasms
  • Nutrition Aspect of Cancer
  • Chemotherapy Effect
  • Immunisation Reaction
Intervention Drug: Omega-3 fish oil fat emulsion
Use omega-3 fish oil fat emulsion
Study Groups/Cohorts
  • 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

    Intervention: 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 14, 2023)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2023
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Liu Ruiqing, Doctor 18661809036 liuruiqing@smail.nju.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT06047158
Other Study ID Numbers RCEOFOITP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party The Affiliated Hospital of Qingdao University
Original Responsible Party Same as current
Current Study Sponsor The Affiliated Hospital of Qingdao University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account The Affiliated Hospital of Qingdao University
Verification Date September 2023