Fish OilsNCT06047158
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
An observational study of Fish Oils and Perfusion; Complications, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fish Oils, Perfusion; Complications, Stomach Neoplasms
- What is being tested?
- Omega-3 fish oil fat emulsion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruiqing Liu
Qingdao, Shandong, 266003
Wang Dongsheng, Doctor, 18661807896, wangds0538@hotmail.com
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Fish Oils, Perfusion; Complications, Stomach Neoplasms, Nutrition Aspect of Cancer, Chemotherapy Effect, Immunisation Reaction
- Being tested
- Omega-3 fish oil fat emulsion
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fish oil fat emulsionDrug
Use omega-3 fish oil fat emulsion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune related index
Peripheral blood lymphocyte count
Measured: one week
Immune related index
Plasma albumin concentration
Measured: one week
Immune related index
C-reactive protein concentration
Measured: one week
Immune related index
Postoperative infectious complications
Measured: one week
Secondary outcomes (2)
Hospitalization related
Hospitalization time
Measured: From the first day after operation to discharge, up to 30 days.
Hospitalization related
Hospitalization expenses
Measured: From the first day after operation to discharge, up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fish OilsStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047158
- Sponsor's protocol ID
- RCEOFOITP
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06047158
- Acronym / sponsor ID
- RCEOFOITP
- Conditions
- Fish Oils, Perfusion; Complications, Stomach Neoplasms, Nutrition Aspect of Cancer, Chemotherapy Effect, Immunisation Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil group | – | Drug: Omega-3 fish oil fat emulsionThe 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 |
| 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fish oil fat emulsionUse omega-3 fish oil fat emulsion | Drug | Fish oil group |
Primary outcome
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
2 secondary outcomes
Hospitalization related
Time frame: From the first day after operation to discharge, up to 30 days.
Hospitalization related
Time frame: From the first day after operation to discharge, up to 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fish Oils and Perfusion; Complications, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Ruiqing, Doctor (18661809036, liuruiqing@smail.nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune related index (time frame: one week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.