Head and Neck CancerNCT07017218
Immunonutrition Effects on Nutrition and Immunity in HNC During Radiotherapy
A study testing IMPACT in people with Head and Neck Cancer and Nutrition, run by First Affiliated Hospital of Chongqing Medical University.
Trial summary
Head and neck cancer (HNC) is one of the most common types of malignant tumors, often leading to malnutrition due to its complex anatomical location near many functional organs. Radiotherapy, an essential treatment modality for HNC, can exacerbate malnutrition, potentially causing radiotherapy failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Nutrition
- What is being tested?
- IMPACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2025to 28 Feb 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be histologically or cytologically confirmed to have head and neck cancer (HNC).
- Scheduled for radiotherapy with or without concurrent chemotherapy.
- Willingness to sign informed consent voluntarily.
- Aged between 18 and 75 years old.
- Karnofsky Performance Status (KPS) score ≥70.
- Hematological and biochemical parameters within the following ranges:
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- White blood cell count (WBC) ≥3.5×10^9/L
- Hemoglobin (Hb) ≥90 g/L
- Platelet count (PLT) ≥100×10^9/L
- Serum albumin (ALB) ≥30 g/L
- Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 - times ULN
- Life expectancy of at least 6 months.
- No severe malnutrition at baseline (e.g., body mass index [BMI] >18.5 kg/m²).
Who cannot join
- Prior history of radiation therapy or biological therapy targeting the head and neck region.
- History of other malignant tumors in the past 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ.
- Severe systemic diseases, such as uncontrolled diabetes mellitus, severe cardiovascular disease, or chronic renal failure.
- Pregnancy or lactation.
- Drug or alcohol abuse.
- Participation in other clinical trials within the last 3 months.
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- Known allergies or contraindications to the nutritional formulations used in this study.
- Mental disorders or cognitive impairments that may affect compliance with the study protocol.
- Inability to tolerate oral nutritional supplements (ONS).
- Any condition deemed by the investigator to potentially interfere with the study objectives or participant safety
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Immune Nutrition on Nutritional and Immune Status of Head and Neck Cancer Patients During Radiotherapy
Head and neck cancer (HNC) is one of the most common types of malignant tumors, often leading to malnutrition due to its complex anatomical location near many functional organs. Radiotherapy, an essential treatment modality for HNC, can exacerbate malnutrition, potentially causing radiotherapy failure. Both domestic and international guidelines advocate early nutritional intervention for HNC patients at risk of malnutrition; however, specific recommendations on the type of nutritional treatment are lacking. Immunonutrition has shown promise in regulating the immune microenvironment, enhancing immune response, and reducing radiotherapy side effects compared to conventional nutritional interventions. However, there is a lack of studies focusing on immunonutritional therapy during the radiotherapy process for HNC in China. Therefore, this study aims to investigate the effects of immunonutrition on nutritional status, immune function, and quality of life (QoL) in head and neck cancer (HNC) patients undergoing radiotherapy.
This prospective interventional study enrolled 48 head and neck cancer (HNC) patients scheduled to undergo radiotherapy (with or without concurrent chemotherapy). All participants received an immunonutrition formula supplemented with arginine, ω-3 fatty acids, and nucleotides. Throughout the radiotherapy course, certified dietitians and oncology nurses provided standardized nutritional guidance based on a five-step nutritional management protocol. Primary outcomes included:Radiotherapy-related adverse events (e.g., mucositis, dysphagia) assessed at four time points during radiotherapy (weeks 1, 3, 5, and 7) using CTCAE v4.0 criteria;Longitudinal changes in nutritional status (serum albumin, BMI), immune-related biomarkers , and quality of life were assessed at baseline, mid-radiotherapy (week 4), and post-treatment (week 7).
- Conditions
- Head and Neck Cancer, Nutrition
- Being tested
- IMPACT
- Keywords
- Head and neck cancer, immunonutrition, radiation
- 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.
IMPACTDietary supplement
immune enhanced formula enriched in arginine, n-3 PUFA and nucleotide
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition | Experimental | Not described Receives: Dietary Supplement: IMPACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of oral mucositis measured by CTCAE v4.0 (Grades 0-4)
The grades of oral mucositis were measured and recorded by our professional nutritionists at four time periods during radiotherapy. The classification standard of oral mucositis was based on CTCAE v4.0 (Grade 0: asymptomatic; Grade I: Erythema appears on the oral mucosa, accompanied by pain, but it does not affect eating; Grade II: Erythema and ulcers appear on the oral mucosa, and solid food can be consumed; Grade III: Severe erythema and ulcers appear on the oral mucosa, and solid food cannot be consumed; Grade IV: Ulcers have fused into patches, with necrosis, and the patient is unable to eat)
Measured: Assessed weekly during radiotherapy at weeks 1, 3, 5, and 7 of treatment
Secondary outcomes (3)
Change in body weight (kg) from baseline
Measured in kilograms using a calibrated scale, with participants in light clothing and fasting overnight
Measured: at baseline, mid-radiotherapy (week 4), and post-treatment (week 7)
Change in Body Mass Index (BMI, kg/m²) from baseline
Calculated from measured weight and height (BMI = weight[kg] / height[m]²)
Measured: at baseline, mid-radiotherapy (week 4), and post-treatment (week 7)
Change in serum albumin concentration (g/dL) from baseline
Measured from venous blood samples using standardized clinical laboratory assays
Measured: at baseline, mid-radiotherapy (week 4), and post-treatment (week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start20 Jun 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
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 First Affiliated Hospital of Chongqing Medical 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zhang, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017218
- Sponsor's protocol ID
- IIT2025-06
- Status last verified
- May 2025
- First submitted
- 24 Mar 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Immune Nutrition on Nutritional and Immune Status of Head and Neck Cancer Patients During Radiotherapy
- ClinicalTrials.gov ID
- NCT07017218
- Acronym / sponsor ID
- IIT2025-06
- Conditions
- Head and Neck Cancer, Nutrition
- Keywords
- Head and neck cancer, immunonutrition, radiation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 12 Jun 2025 (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.
Head and neck cancer (HNC) is one of the most common types of malignant tumors, often leading to malnutrition due to its complex anatomical location near many functional organs. Radiotherapy, an essential treatment modality for HNC, can exacerbate malnutrition, potentially causing radiotherapy failure. Both domestic and international guidelines advocate early nutritional intervention for HNC patients at risk of malnutrition; however, specific recommendations on the type of nutritional treatment are lacking. Immunonutrition has shown promise in regulating the immune microenvironment, enhancing immune response, and reducing radiotherapy side effects compared to conventional nutritional interventions. However, there is a lack of studies focusing on immunonutritional therapy during the radiotherapy process for HNC in China. Therefore, this study aims to investigate the effects of immunonutrition on nutritional status, immune function, and quality of life (QoL) in head and neck cancer (HNC) patients undergoing radiotherapy.
This prospective interventional study enrolled 48 head and neck cancer (HNC) patients scheduled to undergo radiotherapy (with or without concurrent chemotherapy). All participants received an immunonutrition formula supplemented with arginine, ω-3 fatty acids, and nucleotides. Throughout the radiotherapy course, certified dietitians and oncology nurses provided standardized nutritional guidance based on a five-step nutritional management protocol. Primary outcomes included:Radiotherapy-related adverse events (e.g., mucositis, dysphagia) assessed at four time points during radiotherapy (weeks 1, 3, 5, and 7) using CTCAE v4.0 criteria;Longitudinal changes in nutritional status (serum albumin, BMI), immune-related biomarkers , and quality of life were assessed at baseline, mid-radiotherapy (week 4), and post-treatment (week 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition | Experimental | Dietary Supplement: IMPACT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must be histologically or cytologically confirmed to have head and neck cancer (HNC).
- Scheduled for radiotherapy with or without concurrent chemotherapy.
- Willingness to sign informed consent voluntarily.
- Aged between 18 and 75 years old.
- Karnofsky Performance Status (KPS) score ≥70.
Key exclusion criteria (10 listed)
- Prior history of radiation therapy or biological therapy targeting the head and neck region.
- History of other malignant tumors in the past 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ.
- Severe systemic diseases, such as uncontrolled diabetes mellitus, severe cardiovascular disease, or chronic renal failure.
- Pregnancy or lactation.
- Drug or alcohol abuse.
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 |
|---|---|---|
| IMPACTimmune enhanced formula enriched in arginine, n-3 PUFA and nucleotide | Dietary supplement | Immunonutrition |
Primary outcome
Severity of oral mucositis measured by CTCAE v4.0 (Grades 0-4)
Time frame: Assessed weekly during radiotherapy at weeks 1, 3, 5, and 7 of treatment
The grades of oral mucositis were measured and recorded by our professional nutritionists at four time periods during radiotherapy. The classification standard of oral mucositis was based on CTCAE v4.0 (Grade 0: asymptomatic; Grade I: Erythema appears on the oral mucosa, accompanied by pain, but it does not affect eating; Grade II: Erythema and ulcers appear on the oral mucosa, and solid food can be consumed; Grade III: Severe erythema and ulcers appear on the oral mucosa, and solid food cannot be consumed; Grade IV: Ulcers have fused into patches, with necrosis, and the patient is unable to eat)
3 secondary outcomes
Change in body weight (kg) from baseline
Time frame: at baseline, mid-radiotherapy (week 4), and post-treatment (week 7)
Change in Body Mass Index (BMI, kg/m²) from baseline
Time frame: at baseline, mid-radiotherapy (week 4), and post-treatment (week 7)
Change in serum albumin concentration (g/dL) from baseline
Time frame: at baseline, mid-radiotherapy (week 4), and post-treatment (week 7)
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 12 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT in people with Head and Neck Cancer and Nutrition, run by First Affiliated Hospital of Chongqing Medical University.
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 14 inclusion and 10 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: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Tao Zhang, MD (+86 13708311156, tumorzzt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of oral mucositis measured by CTCAE v4.0 (Grades 0-4) (time frame: Assessed weekly during radiotherapy at weeks 1, 3, 5, and 7 of treatment). 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 12 Jun 2025.