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Effect of Nutritional Management on RIOM in Patients With Advanced Head and Neck Cancer

Primary Purpose

Head and Neck Cancer, Nutrition Related Cancer, Radiation-Induced Mucositis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nutrition management
Sponsored by
Jing Yan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, Malnutrition, Radiation-induced Oral Mucositis, nutrition management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Peri-radiotherapy nutrition management group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2023
    Last Updated
    February 8, 2023
    Sponsor
    Jing Yan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05721885
    Brief Title
    Effect of Nutritional Management on RIOM in Patients With Advanced Head and Neck Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jing Yan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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 . 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer, Nutrition Related Cancer, Radiation-Induced Mucositis
    Keywords
    Head and Neck Cancer, Malnutrition, Radiation-induced Oral Mucositis, nutrition management

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Peri-radiotherapy nutrition management group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    nutrition management
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Degree of radiation-induced oral mucositis (RTOG criteria)
    Description
    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).
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wang Shu An, bachelor
    Phone
    18801599435
    Email
    glyywsa@163.com

    12. IPD Sharing Statement

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    Effect of Nutritional Management on RIOM in Patients With Advanced Head and Neck Cancer

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