Lung CancerNCT06531460
Nutritional Therapy Enriched With Omega-3 in Patients With Lung Resection
A study testing Fish oil enteral supplementation, Fish oil oral supplementation and Enteral nutrition without fish oil in people with Lung Cancer and Surgery, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
Trial summary
The aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Surgery
- What is being tested?
- Fish oil enteral supplementation, Fish oil oral supplementation and Enteral nutrition without fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteMexico
- Study dates
- 25 Jul 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lung cancer diagnosis
- Elective surgery for lung resection schedule at least four days before surgery
- Signed informed consent.
Who cannot join
- Acute or chronic organ failure as hepatic or renal insufficiency
- Patients with fish-allergy
- History of any surgery within 3 months
- Immunocompromised patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
National Institute of Respiratory Diseases
Mexico City, 14080
Ana L Gomez-Rodriguez, MSc, +52 1 55 2573 2734, grolucia@yahoo.es
About this study
Official title: Effect of Perioperative Nutrition Enriched With Omega-3 on the Incidence of Infections in Oncologic Patients Following Lung Resection
The aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.
- Conditions
- Lung Cancer, Surgery
- Being tested
- Fish oil enteral supplementation, Fish oil oral supplementation, Enteral nutrition without fish oil, Oral nutritional supplement without fish oil
- Keywords
- lung cancer, omega-3, prehabilitation nutrition, perioperative nutrition, infections, inflammation response
- Medical subject headings
- Lung Neoplasms, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil enteral supplementationDietary supplement
Omega-3 (4.2 g), administered through an enteral feeding tube, three days before surgery
Fish oil oral supplementationDietary supplement
Omega-3 (4.2 g), orally administered enriched nutritional formula, drinking at home three days before surgery
Enteral nutrition without fish oilDietary supplement
Enteral formula without omega-3 administered through an enteral feeding tube, three days before surgery
Oral nutritional supplement without fish oilDietary supplement
Oral nutritional supplement without omega-3 orally administered, drinking at home three days before surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental enteral nutrition | Experimental | Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer enriched enteral formula Receives: Dietary Supplement: Fish oil enteral supplementation |
| Experimental oral nutrition | Experimental | Patients admitted one day before surgery. Home-self administration of enriched enteral formula three days before surgery Receives: Dietary Supplement: Fish oil oral supplementation |
| Standard enteral nutrition | Other | Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer standard enteral formula Receives: Dietary Supplement: Enteral nutrition without fish oil |
| Standard oral nutrition | Other | Patients admitted one day before surgery. Home-self administration of standard enteral formula three days before surgery Receives: Dietary Supplement: Oral nutritional supplement without fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day incidence infection
Incidence of infectious complications after surgery diagnosed using any of these criteria:
Infection of surgery wound confirmed by culture Infection confirmed by blood culture Pneumonia developed after surgery confirmed by chest x Ray.
Measured: 30-day incidence infection following lung resection in lung cancer patients.
Secondary outcomes (5)
Changes in prostaglandin E2
Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).
Measured: At the beginning of nutritional therapy and at day-4 following surgery
Changes in Interleukin-6
Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).
Measured: At the beginning of nutritional therapy and at day-4 following surgery
Changes in Tumor Necrosis Factor Alpha (TNF-α)
Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).
Measured: At the beginning of nutritional therapy and at day-4 following surgery
Number of participants with therapeutic antibiotics prescription
Frequency of therapeutic antibiotics prescription will be collected from medical records and medication administration registers.
Measured: During the hospital stay until 30-day
Hospital lenght of stay
Number of calendar days that elapsed since hospital admission to the day of hospital discharge
Measured: During the hospital stay until 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start25 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ivan Armando Osuna Padilla, National Institute of Respiratory Diseases, Mexico
- Investigators
- Ivan A Osuna-Padilla, PhD, Principal investigator, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531460
- Sponsor's protocol ID
- C34-24
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Nutrition Enriched With Omega-3 on the Incidence of Infections in Oncologic Patients Following Lung Resection
- ClinicalTrials.gov ID
- NCT06531460
- Acronym / sponsor ID
- C34-24
- Conditions
- Lung Cancer, Surgery
- Keywords
- lung cancer, omega-3, prehabilitation nutrition, perioperative nutrition, infections, inflammation response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 1 Aug 2024 (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 aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental enteral nutrition | Experimental | Dietary Supplement: Fish oil enteral supplementationPatients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer enriched enteral formula |
| Experimental oral nutrition | Experimental | Dietary Supplement: Fish oil oral supplementationPatients admitted one day before surgery. Home-self administration of enriched enteral formula three days before surgery |
| Standard enteral nutrition | Other | Dietary Supplement: Enteral nutrition without fish oilPatients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer standard enteral formula |
| Standard oral nutrition | Other | Dietary Supplement: Oral nutritional supplement without fish oilPatients admitted one day before surgery. Home-self administration of standard enteral formula three days before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lung cancer diagnosis
- Elective surgery for lung resection schedule at least four days before surgery
- Signed informed consent.
Key exclusion criteria (4 listed)
- Acute or chronic organ failure as hepatic or renal insufficiency
- Patients with fish-allergy
- History of any surgery within 3 months
- Immunocompromised patients
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 |
|---|---|---|
| Fish oil enteral supplementationOmega-3 (4.2 g), administered through an enteral feeding tube, three days before surgery | Dietary supplement | Experimental enteral nutrition |
| Fish oil oral supplementationOmega-3 (4.2 g), orally administered enriched nutritional formula, drinking at home three days before surgery | Dietary supplement | Experimental oral nutrition |
| Enteral nutrition without fish oilEnteral formula without omega-3 administered through an enteral feeding tube, three days before surgery | Dietary supplement | Standard enteral nutrition |
| Oral nutritional supplement without fish oilOral nutritional supplement without omega-3 orally administered, drinking at home three days before surgery | Dietary supplement | Standard oral nutrition |
Primary outcome
30-day incidence infection
Time frame: 30-day incidence infection following lung resection in lung cancer patients.
Incidence of infectious complications after surgery diagnosed using any of these criteria: Infection of surgery wound confirmed by culture Infection confirmed by blood culture Pneumonia developed after surgery confirmed by chest x Ray.
5 secondary outcomes
Changes in prostaglandin E2
Time frame: At the beginning of nutritional therapy and at day-4 following surgery
Changes in Interleukin-6
Time frame: At the beginning of nutritional therapy and at day-4 following surgery
Changes in Tumor Necrosis Factor Alpha (TNF-α)
Time frame: At the beginning of nutritional therapy and at day-4 following surgery
Number of participants with therapeutic antibiotics prescription
Time frame: During the hospital stay until 30-day
Hospital lenght of stay
Time frame: During the hospital stay until 90-day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Ivan A Osuna-Padilla, PhD principal investigator
Instituto Nacional de Enfermedades Respiratorias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil enteral supplementation, Fish oil oral supplementation and Enteral nutrition without fish oil in people with Lung Cancer and Surgery, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Aug 2024. 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan A Osuna-Padilla, PhD (5487-1700 ext. 5059, ivan.osuna@iner.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day incidence infection (time frame: 30-day incidence infection following lung resection in lung cancer patients.). 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 1 Aug 2024.