Clinical trial NCT05721885: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Nutrition Related Cancer
Radiation-Induced Mucositis
Keywords: Head and Neck Cancer
Malnutrition
Radiation-induced Oral Mucositis
nutrition management
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Degree of radiation-induced oral mucositis (RTOG criteria)
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: