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
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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 |
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Fish Oils Perfusion; Complications Stomach Neoplasms Nutrition Aspect of Cancer Chemotherapy Effect Immunisation Reaction | Drug: Omega-3 fish oil fat emulsion |
The research process is as follows:
- Select patients in the group according to the inclusion and exclusion criteria.
- The patient signed the informed consent form
- 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.
- Using statistical software (SPSS) to judge the statistical difference.
- It is concluded that the use value of omega-3 fish oil fat emulsion (Ewing) is evaluated.
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 |
Group/Cohort | Intervention/treatment |
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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)
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- 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
- 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
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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 |
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
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
Contact: Liu Ruiqing, Doctor | 18661809036 | liuruiqing@smail.nju.edu.cn |
China, Shan Dong | |
Ruiqing Liu | Recruiting |
Qingdao, Shan Dong, China, 266003 | |
Contact: Wang Dongsheng, Doctor 18661807896 wangds0538@hotmail.com |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |