ImmunonutritionNCT06339372
Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours
A study testing Standard feeding and Omega 3 and dipeptiven in people with Immunonutrition and Surgical Outcome, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Immunonutrition, Surgical Outcome, Pain
- What is being tested?
- Standard feeding and Omega 3 and dipeptiven
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Aug 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II .
- Patient undergoing mandibular or oral cavity tumour resection.
- Body mass index (BMI) between 18.5-24.9.
- Patient with serum albumen above 3 gm.
- Patient with written valid consent
Who cannot join
- Patient refusal and uncooperative patients.
- Patient ASA III or IV.
- Age more than 60 or less than 18.
- Serum albumen less than 3.
- Pre-existing severe malnourishment.
- Allergy to test drugs.
- Patients on tranquilizers, hypnotics, sedatives and other psychotropic patient on steroids and NSAID.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (UTI) and pneumonia.
Read the detailed description
Enhanced Recovery after Surgery (ERAS). A series of components that combine to minimize stress and to facilitate the return of function have been described: these include preoperative preparation and medication, fluid balance, anesthesia and postoperative analgesia, pre- and postoperative nutrition, and mobilization.
Nutrition therapy is the provision of nutrition or nutrients either orally (regular diet, therapeutic diet, e.g. fortified food, oral nutritional supplements) or via enteral nutrition (EN) or parenteral nutrition (PN) to prevent or treat malnutrition.
Head and neck cancer surgery usually means surgery to treat cancer of the mouth, throat or larynx . The surgery is complicated and people often experience problems such as wound infections and wound breakdown, as well as infections such as pneumonia.
The use of a nutritional supplement enriched with Omega 3 fatty acids is associated with a greater preoperative weight loss, reduced postoperative pain and decreased postoperative levels of C reactive protein in patients undergoing Roux-en-Y gastric bypass.
- Conditions
- Immunonutrition, Surgical Outcome, Pain, Oral Cavity, Mandibular Tumor
- Being tested
- Standard feeding, Omega 3 and dipeptiven
- Medical subject headings
- Pain, Mandibular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard feedingDietary supplement
Patients received only standard feeding with caloric distribution (45%-50% carbohydrates,20_35% from fats and 10-35% from protein)
Omega 3 and dipeptivenDietary supplement
Patients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding.
| Study group | Role | What they receive |
|---|---|---|
| Group A (standard feeding) | Other | Patients received only standard feeding with caloric distribution (45%-50% carbohydrates,20-35% from fats and 10-35% from protein) Receives: Dietary Supplement: Standard feeding |
| Group B (immunonutrition mixture) | Experimental | Patients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding. Receives: Dietary Supplement: Omega 3 and dipeptiven |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of wound infection
Evidence of redness and tenderness of surgical wound with discharge of pus was defined as a wound infection.
Measured: 28 days after intervention
Secondary outcomes (7)
Fistula formation
Fistula formation was measured postoperatively.
Measured: 28 days after intervention
Length of hospital stay
Length of hospital stay was measured from admission discharge from hospital
Measured: 28 days after intervention
Total dose of intraoperative opioids
Total dose of intraoperative opioids was calculated in either group
Measured: Intraoperative
Total dose of postoperative opioids
Total dose of postoperative opioids was calculated in either group
Measured: 12 hours postoperative
Degree of pain
Postoperative pain will be assessed by visual analogue scale (VAS) every 4 h. for 12 h. Patients reporting VAS score (more than 3) will receive rescue analgesics. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 12 hours postoperative
The incidence of mortality
Mortality was measured postoperatively
Measured: 28 days after intervention
The incidence of complications
Postoperative complications as urinary tract infection (UTI)and pneumonia.
Measured: 12 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Feb 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunonutritionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Saed Ramadan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339372
- Sponsor's protocol ID
- AP1912-30102
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours
- ClinicalTrials.gov ID
- NCT06339372
- Acronym / sponsor ID
- AP1912-30102
- Conditions
- Immunonutrition, Surgical Outcome, Pain, Oral Cavity, Mandibular Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Apr 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 was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (UTI) and pneumonia.
Detailed description
Enhanced Recovery after Surgery (ERAS). A series of components that combine to minimize stress and to facilitate the return of function have been described: these include preoperative preparation and medication, fluid balance, anesthesia and postoperative analgesia, pre- and postoperative nutrition, and mobilization.
Nutrition therapy is the provision of nutrition or nutrients either orally (regular diet, therapeutic diet, e.g. fortified food, oral nutritional supplements) or via enteral nutrition (EN) or parenteral nutrition (PN) to prevent or treat malnutrition.
Head and neck cancer surgery usually means surgery to treat cancer of the mouth, throat or larynx . The surgery is complicated and people often experience problems such as wound infections and wound breakdown, as well as infections such as pneumonia.
The use of a nutritional supplement enriched with Omega 3 fatty acids is associated with a greater preoperative weight loss, reduced postoperative pain and decreased postoperative levels of C reactive protein in patients undergoing Roux-en-Y gastric bypass.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (standard feeding) | Other | Dietary Supplement: Standard feedingPatients received only standard feeding with caloric distribution (45%-50% carbohydrates,20-35% from fats and 10-35% from protein) |
| Group B (immunonutrition mixture) | Experimental | Dietary Supplement: Omega 3 and dipeptivenPatients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II .
- Patient undergoing mandibular or oral cavity tumour resection.
- Body mass index (BMI) between 18.5-24.9.
Key exclusion criteria (7 listed)
- Patient refusal and uncooperative patients.
- Patient ASA III or IV.
- Age more than 60 or less than 18.
- Serum albumen less than 3.
- Pre-existing severe malnourishment.
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 |
|---|---|---|
| Standard feedingPatients received only standard feeding with caloric distribution (45%-50% carbohydrates,20_35% from fats and 10-35% from protein) | Dietary supplement | Group A (standard feeding) |
| Omega 3 and dipeptivenPatients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding. | Dietary supplement | Group B (immunonutrition mixture) |
Primary outcome
The incidence of wound infection
Time frame: 28 days after intervention
Evidence of redness and tenderness of surgical wound with discharge of pus was defined as a wound infection.
7 secondary outcomes
Fistula formation
Time frame: 28 days after intervention
Length of hospital stay
Time frame: 28 days after intervention
Total dose of intraoperative opioids
Time frame: Intraoperative
Total dose of postoperative opioids
Time frame: 12 hours postoperative
Degree of pain
Time frame: 12 hours postoperative
The incidence of mortality
Time frame: 28 days after intervention
The incidence of complications
Time frame: 12 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Immunonutrition
Recruiting
Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer
Lung Cancer, Nonsmall Cell
Enrolling by invitation
Immunonutrition for Surgical Prehabilitation of Patients With Upper GI Cancer
Upper GI Cancer
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
Recruiting
Melatonin and Immunonutrition for Pain Relief in Fibromyalgia
Fibromyalgia
RecruitingPhase 2
Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma
Locally Advanced Esophageal Squamous Cell Carcinoma, Sintilimab
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard feeding and Omega 3 and dipeptiven in people with Immunonutrition and Surgical Outcome, run by Cairo University at 1 site in Egypt.
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 7 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: finished, as of the sponsor's last update on 2 Apr 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of wound infection (time frame: 28 days after intervention). 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 2 Apr 2024.