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

NCT05721885 | Unknown

• 1 other identifier: 2022-496-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Head and Neck Cancer; Malnutrition; Radiation-induced Oral Mucositis; nutrition management

Outcome Measures

Primary Outcomes (1)

• 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).

  six months

Study Arms (1)

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.

Behavioral: nutrition management

Interventions

nutrition management BEHAVIORAL

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.

Peri-radiotherapy nutrition management group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jing Yan: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Malnutrition

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Wang Shu An, bachelor

CONTACT

18801599435; glyywsa@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician/Deputy Administrative Director of Oncology Department, Nanjing Drum Tower Hospital

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 10, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 10, 2023

Record last verified: 2023-02