The SHINE-MDT Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Head and Neck Carcinoma
• Interventions: Behavioral: Whole-Course Multidisciplinary Care Intervention

• Registration Number: NCT05828004
• Lead Sponsor: West China Hospital

Brief Summary

Radiotherapy is one of the main treatments for head and neck Carcinoma. The incidence of radiotherapy-related adverse events is greater than 90%, and severe adverse events may lead to the interruption of radiotherapy.

Interruption of radiotherapy on the one hand affects the efficacy of tumor treatment, on the other hand seriously affects the quality of life of patients.

Investigators intend to conduct a randomized, controlled clinical study of multidisciplinary nutritional and psychological care for patients receiving radiotherapy for head and neck carcinoma, with a view to reducing the rate of radiotherapy interruption and improving the quality of life of patients with radiotherapy for head and neck carcinoma through a whole-course multidisciplinary care model.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-14
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-04-25
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

1. The patient is willing and capable of signing the informed consent;
2. Patient age ≥18 years;
3. Non-metastatic head and neck tumors (including nasopharyngeal carcinoma) were confirmed by pathology;
4. Patients need to receive postoperative adjuvant radiotherapy or radical radiotherapy;
5. Expected survival ≥6 months;
6. Baseline ECOG (Eastern Cooperative Oncology Group) score 0-3;
7. Good cognitive and reading skills, able to complete the questionnaire survey.

Exclusion Criteria

1. The patient has malignancies other than head and neck malignancies (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);
2. The patient had previously received radiotherapy;
3. Previous history of mental illness or cognitive impairment (MMSE score < 27 points);
4. There are contraindications to radiotherapy for head and neck, such as grade 3 or 4 suppression of bone marrow function and active head and neck infection.
5. The presence of uncontrolled systemic diseases that seriously affect the quality of life, such as poorly controlled diabetes, heart failure (NYHA grade III-IV), interstitial lung disease, etc.;
6. Pregnant women or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MDT care group	Whole-Course Multidisciplinary Care Intervention	The MDT care group is the whole-course multidisciplinary care intervention group, which is conducted by a multidisciplinary team composed of the oncology department, nutrition department, mental health center and rehabilitation department.

Primary Outcome Measures

Name	Time	Method
Radiotherapy interruption rate	5 days	Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days

Secondary Outcome Measures

Name	Time	Method
Quality of life score QLQ-HN35	once a week during radiotherapy;1, 2, 3 and 6 months after radiotherapy	Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35
Quality of life score (EORTC QLQ C30)	once a week during radiotherapy;1, 2, 3 and 6 months after radiotherapy	Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30)

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China