Head and neck tumors
Conditions
Interventions
intervention group:Early nutritional intervention: The intervention period is from 2 weeks before radiotherapy to 3 months after radiotherapy. Nutrition education begins 2 weeks before radiotherapy, a
the second step is normal diet and oral nutritional supplements (ONS)
The third tier is total enteral nutrition (TEN), including ONS and tube feeding
The fourth stage is partial enteral nutrition (PEN) and partial parenteral nutrition (PPN)
the fifth stage is total parenteral nutrition (TPN)
When the first level cannot meet the patient s needs for 3-5 days, the next level should be entered. Energy requirement of patients: It is recommended to calculate the daily energy requirement based o
The dosage is converted according to the different energy requirements of patients.
Sponsors
peking university shenzhen hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Age and gender: 18 or above, 75 years old or below, male or female; 2. Within the previous six months, the patient had not received any local treatment for the head and neck, including surgery and radiotherapy; 3. Patients who received concurrent chemoradiotherapy or radiotherapy alone after surgery or who received radical concurrent chemoradiotherapy or radiotherapy alone without treatment; 4. Head and neck squamous cell carcinoma confirmed by histology or cytology; 5. Inpatients or outpatients undergoing radiotherapy; 6. The presence of the following high-risk factors: extracapsular invasion of lymph nodes, positive or insufficient surgical margins, proximity to the surgical margin, stage T3N0M0-T4N3M0, lymph nodes located in IV or V regions, vascular invasion, peripheral nerve infiltration, or patients considered by the surgeon to have high-risk recurrence factors; 7. ECOG score is 0-2; 8. The patient or his/her relatives have sufficient cognitive and reading abilities. If the participant and his/her legal representative do not have literacy skills, the informed consent process should be witnessed by a witness. After the participant or his/her legal representative verbally agrees, they should sign the informed consent form; 9. Had not received head and neck radiotherapy before receiving this treatment; 10. Be able to actively cooperate with follow-up calls, outpatient visits, or online (such as WeChat) visits in the later stages.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patients who did not receive radiotherapy after surgery due to various reasons; 2. Patients who have received radiation therapy in the head and neck region in the past; 3. Patients who cannot cooperate with telephone or online (such as WeChat) or outpatient follow-up within 2 years after treatment; 4. Other situations that the project team doctors judged were not suitable for participating in this clinical trial. Exit criteria: 1. The patient has a sudden concomitant disease, which makes it inappropriate for him to continue participating in the trial and requires continuous treatment (the reason must be recorded); 2. Patients who wish to withdraw from the trial for any reason (reasons must be recorded).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year local control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence, severity, duration, probability of recovery, degree of recovery, and impact of recovery time of toxic side effects; | — |
Countries
China
Contacts
Public ContactGuoqiang Li
Peking University Shenzhen Hospital
Outcome results
None listed