Effect of Nutritional Management on RIOM in Patients With Advanced Head and Neck Cancer
NCT ID: NCT05721885
Last Updated: 2023-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2023-03-01
2025-12-31
Brief Summary
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* \[question 1\]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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
Group B: peri-radiotherapy nutrition management group, standard anti-tumor therapy combined with peri-radiotherapy nutrition management.
SUPPORTIVE_CARE
NONE
Study Groups
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Peri-radiotherapy nutrition management group
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.
nutrition management
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.
Interventions
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nutrition management
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Jing Yan
OTHER
Responsible Party
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Jing Yan
Chief Physician/Deputy Administrative Director of Oncology Department, Nanjing Drum Tower Hospital
Central Contacts
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Other Identifiers
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2022-496-02
Identifier Type: -
Identifier Source: org_study_id
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