Head and Neck CancerNCT06318221
Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer
A study testing Experimental (Immunonutrition) Group and Active Comparator Group ( Standard enteral nutrition) in people with Head and Neck Cancer and Nutrition, Healthy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Nutrition, Healthy
- What is being tested?
- Experimental (Immunonutrition) Group and Active Comparator Group ( Standard enteral nutrition)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Feb 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx who will undergo surgery,
- who agree to receive standard EN or immunonutrition before surgery,
- those between the ages of 18-75,
- those with normal hematopoietic (absolute neutrophil count >1.8x109/L, hemoglobin level ≥9 g/dL) hepatic and renal function
Who cannot join
- Patients receiving neoadjuvant chemotherapy or radiotherapy to the head and neck region;
- Received EN support before the study
- have an active infection, any autoimmune, renal or hepatic disease, malabsorption, type 1 diabetes or mental illness
- taking vitamin-mineral supplements and immunosuppressive treatment,
- Morbidly obese (BMI ≥40 kg/m2), HIV positive, pregnant and breastfeeding individuals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial With Perioperative Immunonutrition Support on Anthropometric, Clinical and Biochemical Parameters of Head and Neck Cancer Patients Undergoing Surgery
A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC).
Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded.
- Conditions
- Head and Neck Cancer, Nutrition, Healthy
- Being tested
- Experimental (Immunonutrition) Group, Active Comparator Group ( Standard enteral nutrition)
- Keywords
- head and neck cancer, immunonutrition, enteral nutrition, Perioperative nutrition, Nutritional counseling
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (Immunonutrition) GroupDietary supplement
Immunonutrition was given to the patients in the intervention group and ready-to-use liquid in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day as taken between meals.
In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. The ready-to-use immunonutrition product was given to the patients in the intervention group.
Active Comparator Group ( Standard enteral nutrition)Dietary supplement
Standard enteral nutrition was given to patients in the control group in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day between meals.
In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. Liquid standard enteral nutrition was given to the patients in the control group.
| Study group | Role | What they receive |
|---|---|---|
| immunonutrition (intervention group) | Experimental | Immunonutrition enteral products was given to the patients in the intervention group Receives: Dietary Supplement: Experimental (Immunonutrition) Group |
| standard (control group) | Active comparator | Standard enteral products was given to patients in the control group. Receives: Dietary Supplement: Active Comparator Group ( Standard enteral nutrition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Kg
Measured: 40 days
Body weight loss
Kg
Measured: 40 days
Body mass index
kg/m2
Measured: 40 days
Resting metabolic rate
kcal
Measured: 40 days
Nutrition Risk Screening 2002
A total score of ≥3 indicates that the patient is at nutritional risk
Measured: 40 days
The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30)
- Estimate the average of the items that contribute to the scale; this is the raw score.
- Use a linear transformation to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Measured: 40 days
The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35)
The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning).
Measured: 40 days
Albumin
g/dL
Measured: 40 days
C-reactive protein
mg/L
Measured: 40 days
Prealbumin
mg/dL
Measured: 40 days
Secondary outcomes (2)
Length of hospital stay
days
Measured: 40 days
Complication development status
It was evaluated as yes/no.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 May 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Model description
- Patients were classified according to tumor location (oral cavity, oropharynx, larynx or hypopharynx) and body weight loss, approximately equally in both groups. Accordingly, patients were randomly assigned (by computer) into either the immunonutrition (intervention group) or standard EN (control group) groups.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Başmısırlı, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318221
- Sponsor's protocol ID
- 06156930
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial With Perioperative Immunonutrition Support on Anthropometric, Clinical and Biochemical Parameters of Head and Neck Cancer Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT06318221
- Acronym / sponsor ID
- 06156930
- Conditions
- Head and Neck Cancer, Nutrition, Healthy
- Keywords
- head and neck cancer, immunonutrition, enteral nutrition, Perioperative nutrition, Nutritional counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 19 Mar 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.
A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC).
Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were classified according to tumor location (oral cavity, oropharynx, larynx or hypopharynx) and body weight loss, approximately equally in both groups. Accordingly, patients were randomly assigned (by computer) into either the immunonutrition (intervention group) or standard EN (control group) groups.
| Arm | Type | Receives |
|---|---|---|
| immunonutrition (intervention group) | Experimental | Dietary Supplement: Experimental (Immunonutrition) GroupImmunonutrition enteral products was given to the patients in the intervention group |
| standard (control group) | Active comparator | Dietary Supplement: Active Comparator Group ( Standard enteral nutrition)Standard enteral products was given to patients in the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx who will undergo surgery,
- who agree to receive standard EN or immunonutrition before surgery,
- those between the ages of 18-75,
- those with normal hematopoietic (absolute neutrophil count >1.8x109/L, hemoglobin level ≥9 g/dL) hepatic and renal function
Key exclusion criteria (5 listed)
- Patients receiving neoadjuvant chemotherapy or radiotherapy to the head and neck region;
- Received EN support before the study
- have an active infection, any autoimmune, renal or hepatic disease, malabsorption, type 1 diabetes or mental illness
- taking vitamin-mineral supplements and immunosuppressive treatment,
- Morbidly obese (BMI ≥40 kg/m2), HIV positive, pregnant and breastfeeding individuals
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 |
|---|---|---|
| Experimental (Immunonutrition) GroupImmunonutrition was given to the patients in the intervention group and ready-to-use liquid in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day as taken between meals. In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. The ready-to-use immunonutrition product was given to the patients in the intervention group. | Dietary supplement | immunonutrition (intervention group) |
| Active Comparator Group ( Standard enteral nutrition)Standard enteral nutrition was given to patients in the control group in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day between meals. In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. Liquid standard enteral nutrition was given to the patients in the control group. | Dietary supplement | standard (control group) |
Primary outcome
Body weight
Time frame: 40 days
Kg
Body weight loss
Time frame: 40 days
Kg
Body mass index
Time frame: 40 days
kg/m2
Resting metabolic rate
Time frame: 40 days
kcal
Nutrition Risk Screening 2002
Time frame: 40 days
A total score of ≥3 indicates that the patient is at nutritional risk
The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30)
Time frame: 40 days
1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35)
Time frame: 40 days
The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning).
Albumin
Time frame: 40 days
g/dL
C-reactive protein
Time frame: 40 days
mg/L
Prealbumin
Time frame: 40 days
mg/dL
2 secondary outcomes
Length of hospital stay
Time frame: 40 days
Complication development status
Time frame: 40 days
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 19 Mar 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. 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 Experimental (Immunonutrition) Group and Active Comparator Group ( Standard enteral nutrition) in people with Head and Neck Cancer and Nutrition, Healthy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 19 Mar 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 Turkey (Türkiye). 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?
Body weight (time frame: 40 days). The study lists 10 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 19 Mar 2024.