Head and Neck CancerNCT05721885
Effect of Nutritional Management on RIOM in Patients With Advanced Head and Neck Cancer
A study testing nutrition management in people with Head and Neck Cancer and Nutrition Related Cancer, run by Jing Yan.
Trial summary
The goal of this clinical trial is to learn about the effect of nutritional management on radiation-induced oral mucositis in patients with advanced head and neck cancer during the peri-radiotherapy period . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer, Nutrition Related Cancer, Radiation-Induced Mucositis
- What is being tested?
- nutrition management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 31 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years old
- Advanced head and neck cancer (III-IV inoperable) is clearly diagnosed
- Predicted survival time > 3 months
- Radical radiotherapy combined with chemotherapy or immunotherapy was performed in our hospital
- The patient has clear consciousness and no communication disorder
- Informed consent and voluntary participation in this study
Who cannot join
- Patients with previous surgery or radiotherapy for head and neck cancer
- Patients with concurrent or previous history of other tumors
- Distant metastasis
- Patients with allergy, intolerance or contraindication to enteral nutrition or parenteral nutrition
- Severe renal insufficiency (eGFR<30ml/min/1.73m2)
- Combined with poorly controlled metabolic diseases such as diabetes
- Doctors or researchers deem that they are not suitable to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Single-arm Cohort Study on the Effect of Peri-radiotherapy Nutrition Management on Radiation-induced Oral Mucositis in Patients With Advanced Head and Neck Cancer
The goal of this clinical trial is to learn about the effect of nutritional management on radiation-induced oral mucositis in patients with advanced head and neck cancer during the peri-radiotherapy period . The main questions it aims to answer are:
- [question 1]Whether whole-course nutritional intervention can improve radiation-induced oral mucositis in patients with HNC.
- [question 2]Whether whole-course nutritional intervention can improve nutritional status and inflammation.
Read more
Participants will be treated according to the NCCN guidelines. In addition, clinical pharmacists and registered dietitians provided nutritional intervention strategies based on clinical and nutritional assessments for the patients in the peri-radiotherapy nutrition group.
Researchers will compare clinical routine examination and nutritional indicators between the standard treatment group and the peri-radiotherapy nutrition management group to see if nutrition management effects.
- Being tested
- nutrition management
- Keywords
- Head and Neck Cancer, Malnutrition, Radiation-induced Oral Mucositis, nutrition management
- Medical subject headings
- Head and Neck Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition managementBehavioural
Nutritional management was performed by clinical pharmacists and registered dietitians to develop nutritional intervention strategies based on patient clinical assessment and nutritional assessment. PG-SGA score was 0-3 points, and diet guidance was given. PG-SGA score > 4 points, artificial nutrition intervention was carried out, and the way and amount of nutritional intervention were clarified to achieve the final daily energy and protein target requirements. Nutritional interventions and assessments were adjusted over time.
| Study group | Role | What they receive |
|---|---|---|
| Peri-radiotherapy nutrition management group | Other | Nutritional management was performed by clinical pharmacists and registered dietitians to develop nutritional intervention strategies based on patient clinical assessment and nutritional assessment. PG-SGA score was 0-3 points, and diet guidance was given. PG-SGA score > 4 points, artificial nutrition intervention was carried out, and the way and amount of nutritional intervention were clarified to achieve the final daily energy and protein target requirements. Nutritional interventions and assessments were adjusted over time. Receives: Behavioral: nutrition management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of radiation-induced oral mucositis (RTOG criteria)
The Radiation Oncology Group (RTOG) grade of acute radiation injury was used for evaluation, which was divided into 0 to Ⅳ grades. The mild grade included 0, Ⅰ, and Ⅱgrades (grade 0 was no mucosal response; GradeⅠ: erythema, mild pain; GradeⅡ: spotty mucositis with serous exudation), severe grade Ⅲ- IV (Ⅲ: patchy fibrous mucositis with severe pain; Grade IV: necrosis, ulcer, hemorrhage).
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Group A: standard treatment group, standard anti-tumor treatment, clinicians in accordance with the NCCN anti-tumor treatment guidelines. Group B: peri-radiotherapy nutrition management group, standard anti-tumor therapy combined with peri-radiotherapy nutrition management.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Yan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721885
- Sponsor's protocol ID
- 2022-496-02
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm Cohort Study on the Effect of Peri-radiotherapy Nutrition Management on Radiation-induced Oral Mucositis in Patients With Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05721885
- Acronym / sponsor ID
- 2022-496-02
- Keywords
- Head and Neck Cancer, Malnutrition, Radiation-induced Oral Mucositis, nutrition management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jing YanUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Feb 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 goal of this clinical trial is to learn about the effect of nutritional management on radiation-induced oral mucositis in patients with advanced head and neck cancer during the peri-radiotherapy period . The main questions it aims to answer are:
- [question 1]Whether whole-course nutritional intervention can improve radiation-induced oral mucositis in patients with HNC.
- [question 2]Whether whole-course nutritional intervention can improve nutritional status and inflammation.
Participants will be treated according to the NCCN guidelines. In addition, clinical pharmacists and registered dietitians provided nutritional intervention strategies based on clinical and nutritional assessments for the patients in the peri-radiotherapy nutrition group.
Researchers will compare clinical routine examination and nutritional indicators between the standard treatment group and the peri-radiotherapy nutrition management group to see if nutrition management effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Group A: standard treatment group, standard anti-tumor treatment, clinicians in accordance with the NCCN anti-tumor treatment guidelines. Group B: peri-radiotherapy nutrition management group, standard anti-tumor therapy combined with peri-radiotherapy nutrition management.
| Arm | Type | Receives |
|---|---|---|
| Peri-radiotherapy nutrition management group | Other | Behavioral: nutrition managementNutritional management was performed by clinical pharmacists and registered dietitians to develop nutritional intervention strategies based on patient clinical assessment and nutritional assessment. PG-SGA score was 0-3 points, and diet guidance was given. PG-SGA score > 4 points, artificial nutrition intervention was carried out, and the way and amount of nutritional intervention were clarified to achieve the final daily energy and protein target requirements. Nutritional interventions and assessments were adjusted over time. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 80 years old
- Advanced head and neck cancer (III-IV inoperable) is clearly diagnosed
- Predicted survival time > 3 months
- Radical radiotherapy combined with chemotherapy or immunotherapy was performed in our hospital
- The patient has clear consciousness and no communication disorder
Key exclusion criteria (7 listed)
- Patients with previous surgery or radiotherapy for head and neck cancer
- Patients with concurrent or previous history of other tumors
- Distant metastasis
- Patients with allergy, intolerance or contraindication to enteral nutrition or parenteral nutrition
- Severe renal insufficiency (eGFR<30ml/min/1.73m2)
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 |
|---|---|---|
| nutrition managementNutritional management was performed by clinical pharmacists and registered dietitians to develop nutritional intervention strategies based on patient clinical assessment and nutritional assessment. PG-SGA score was 0-3 points, and diet guidance was given. PG-SGA score > 4 points, artificial nutrition intervention was carried out, and the way and amount of nutritional intervention were clarified to achieve the final daily energy and protein target requirements. Nutritional interventions and assessments were adjusted over time. | Behavioural | Peri-radiotherapy nutrition management group |
Primary outcome
Degree of radiation-induced oral mucositis (RTOG criteria)
Time frame: six months
The Radiation Oncology Group (RTOG) grade of acute radiation injury was used for evaluation, which was divided into 0 to Ⅳ grades. The mild grade included 0, Ⅰ, and Ⅱgrades (grade 0 was no mucosal response; GradeⅠ: erythema, mild pain; GradeⅡ: spotty mucositis with serous exudation), severe grade Ⅲ- IV (Ⅲ: patchy fibrous mucositis with severe pain; Grade IV: necrosis, ulcer, hemorrhage).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition management in people with Head and Neck Cancer and Nutrition Related Cancer, run by Jing Yan.
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 6 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: status not confirmed, as of the sponsor's last update on 10 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Shu An, bachelor (18801599435, glyywsa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of radiation-induced oral mucositis (RTOG criteria) (time frame: six months). 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 10 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.