Head and Neck CarcinomaNCT05828004
The SHINE-MDT Randomized Controlled Trial
A study testing Whole-Course Multidisciplinary Care Intervention in people with Head and Neck Carcinoma and Radiotherapy Side Effects, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma, Radiotherapy Side Effects
- What is being tested?
- Whole-Course Multidisciplinary Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had pathologically confirmed malignant head and neck tumors without distant metastasis.
- Patient age ≥18 years;
- Patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy.
- Baseline ECOG (Eastern Cooperative Oncology Group) score 0-2;
- Good cognitive and reading skills, able to complete the questionnaire survey.
Who cannot join
- Presence of other malignant tumors aside from head and neck malignancies;
- A history of prior head and neck radiotherapy;
- Mental illness or cognitive impairments;
- Uncontrolled systemic diseases that could significantly affect their QoL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Multidisciplinary Team Support on Head and Neck Cancer Patients Receiving Radiotherapy: The SHINE-MDT Randomized Controlled Trial
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.
The management of nutritional, psychological, and rehabilitative issues in patients undergoing radiotherapy for head and neck cancer presents unique clinical challenges. We aimed to evaluate the efficacy of the SHINE-MDT (Supportive Holistic Interventions by Nurses and Experts via Multidisciplinary Team) in reducing radiotherapy interruptions and improving patients' quality of life (QoL) compared with usual care.
- Conditions
- Head and Neck Carcinoma, Radiotherapy Side Effects
- Being tested
- Whole-Course Multidisciplinary Care Intervention
- Keywords
- Head and Neck Carcinoma, Multidisciplinary Team, Radiotherapy interruption, Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Course Multidisciplinary Care InterventionBehavioural
On the basis of standard treatment, all patients were evaluated by senior practice nurses in the Department of Oncology in person at the time of enrollment (before radiotherapy) and once every week during radiotherapy, and once in person/over the phone at 1, 2, 3, and 6 months after radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| standard care group | No intervention | The standard care group is the routine care group, that is, under the current standard antitumor treatment and follow-up mode, the patients independently decided whether to carry out nutritional and psychological intervention after the advice from the medical care department of oncology |
| MDT care group | Experimental | 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. Receives: Behavioral: Whole-Course Multidisciplinary Care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiotherapy interruption rate
Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days
Measured: 5 days
Secondary outcomes (4)
Quality of life score (EORTC QLQ C30)
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)
Measured: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Quality of life score QLQ-HN35
Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35
Measured: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Nutritional status (NRS 2002, PG-SGA)
Nutritional status was calculated according to Nutrition Risk Screening 2002 and Patient-Generated Subjective Global Assessment。
Measured: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Psychological status (DT, PHQ-9, HADS)
Psychological status was calculated according to Distress Thermometer (DT), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9)
Measured: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start27 Apr 2023
- Primary completion1 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Ph.D, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828004
- Sponsor's protocol ID
- 2022-1831
- Status last verified
- Aug 2025
- First submitted
- 2 Feb 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pei Y, Wang J, Li J, Chen Y, He J, Wei Z, Liu Z, Su Y, Dai T, Yin L, Deng Y, Zhou J, Tian H, Li Y, Chen X, Zhang S, Chen Y, Yan Q, Li R, Jiang Z, Hu X, Peng X. Multidisciplinary Team Support for Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2547590. doi: 10.1001/jamanetworkopen.2025.47590.
PubMed 41396606
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multidisciplinary Team Support on Head and Neck Cancer Patients Receiving Radiotherapy: The SHINE-MDT Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05828004
- Acronym / sponsor ID
- 2022-1831
- Conditions
- Head and Neck Carcinoma, Radiotherapy Side Effects
- Keywords
- Head and Neck Carcinoma, Multidisciplinary Team, Radiotherapy interruption, Supportive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The management of nutritional, psychological, and rehabilitative issues in patients undergoing radiotherapy for head and neck cancer presents unique clinical challenges. We aimed to evaluate the efficacy of the SHINE-MDT (Supportive Holistic Interventions by Nurses and Experts via Multidisciplinary Team) in reducing radiotherapy interruptions and improving patients' quality of life (QoL) compared with usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care group | No intervention | –The standard care group is the routine care group, that is, under the current standard antitumor treatment and follow-up mode, the patients independently decided whether to carry out nutritional and psychological intervention after the advice from the medical care department of oncology |
| MDT care group | Experimental | Behavioral: Whole-Course Multidisciplinary Care InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients had pathologically confirmed malignant head and neck tumors without distant metastasis.
- Patient age ≥18 years;
- Patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy.
- Baseline ECOG (Eastern Cooperative Oncology Group) score 0-2;
- Good cognitive and reading skills, able to complete the questionnaire survey.
Key exclusion criteria (4 listed)
- Presence of other malignant tumors aside from head and neck malignancies;
- A history of prior head and neck radiotherapy;
- Mental illness or cognitive impairments;
- Uncontrolled systemic diseases that could significantly affect their QoL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Course Multidisciplinary Care InterventionOn the basis of standard treatment, all patients were evaluated by senior practice nurses in the Department of Oncology in person at the time of enrollment (before radiotherapy) and once every week during radiotherapy, and once in person/over the phone at 1, 2, 3, and 6 months after radiotherapy. | Behavioural | MDT care group |
Primary outcome
Radiotherapy interruption rate
Time frame: 5 days
Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days
4 secondary outcomes
Quality of life score (EORTC QLQ C30)
Time frame: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Quality of life score QLQ-HN35
Time frame: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Nutritional status (NRS 2002, PG-SGA)
Time frame: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Psychological status (DT, PHQ-9, HADS)
Time frame: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Derived from this study: PubMed 41396606Pei Y, Wang J, Li J, Chen Y, He J, Wei Z, Liu Z, Su Y, Dai T, Yin L, Deng Y, Zhou J, Tian H, Li Y, Chen X, Zhang S, Chen Y, Yan Q, Li R, Jiang Z, Hu X, Peng X. Multidisciplinary Team Support for Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2547590. doi: 10.1001/jamanetworkopen.2025.47590.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xingchen Peng, Ph.D principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Course Multidisciplinary Care Intervention in people with Head and Neck Carcinoma and Radiotherapy Side Effects, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiotherapy interruption rate (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05828004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.