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

February 8, 2023 updated by: Jing Yan

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wang Shu An, bachelor
  • Phone Number: 18801599435
  • Email: glyywsa@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jing Yan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2023

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (ACTUAL)

February 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-496-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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