Head & Neck CancerC-Head-002NCT07531563
Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy
A study testing Hydrolyzed Whey Protein Oral Supplement in people with Head & Neck Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
This clinical trial aims to evaluate whether oral supplementation with a hydrolyzed whey protein formula ("TeYiShu") can reduce the incidence of severe radiation-induced oral mucositis and improve prealbumin levels in patients undergoing radiotherapy for head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head & Neck Cancer
- What is being tested?
- Hydrolyzed Whey Protein Oral Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- No distant metastases (M0 stage)
- Planned to receive curative or postoperative radiotherapy (with or without concurrent therapy) with a mean oral cavity dose ≥20 Gy
- Adequate nutritional intake via oral or nasogastric route
- Willingness to follow NCCN/MASCC guidelines for oral care during radiotherapy
- Signed written informed consent
Who cannot join
- PG-SGA score ≥8 (indicating severe nutritional risk)
- Use of non-guideline-recommended oral care during radiotherapy
- Use of other protein supplementation products during radiotherapy
- Known allergy to components of the study product
- Acute or chronic renal insufficiency
- Severe hepatic impairment
Show all 11Show fewer
- Congestive heart failure requiring fluid restriction
- Gastrointestinal disorders affecting amino acid absorption (e.g., atrophic gastritis, bowel obstruction, inflammatory bowel disease)
- Conditions increasing aspiration risk (e.g., abdominal compartment syndrome, gastric emptying disorders)
- Inborn errors of amino acid metabolism
- Cognitive impairment, psychiatric illness, or other factors affecting compliance or informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Oral Protein Hydrolysate Supplementation on Radiation-Induced Severe Oral Mucositis and Prealbumin Levels in Patients With Head and Neck Squamous Cell Carcinoma
This clinical trial aims to evaluate whether oral supplementation with a hydrolyzed whey protein formula ("TeYiShu") can reduce the incidence of severe radiation-induced oral mucositis and improve prealbumin levels in patients undergoing radiotherapy for head and neck squamous cell carcinoma (HNSCC). The study will compare the protein supplement to an isocaloric placebo without protein, maintaining equal caloric intake across groups. Participants will receive either the protein supplement or placebo daily throughout the course of radiotherapy. The primary outcomes are the incidence of grade ≥3 oral mucositis, assessed using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria, and changes in serum prealbumin levels. Secondary outcomes include the time to onset and resolution of mucositis, nutritional status changes, adverse events, and quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Cancer Module (EORTC QLQ-H\&N35).
Read the detailed description
This study is a randomized, controlled clinical trial designed to evaluate the effect of oral hydrolyzed whey protein supplementation on radiation-induced oral mucositis and nutritional status in patients with head and neck squamous cell carcinoma (HNSCC) receiving radiotherapy. Participants will be assigned to receive either a hydrolyzed whey protein formula ("TeYiShu") or an isocaloric placebo without protein during the course of radiotherapy, in addition to standard nutritional counseling and baseline nutrition support.
The primary objectives are to determine whether protein supplementation reduces the incidence of Grade 3 or higher radiation-induced oral mucositis, assessed according to the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria, and improves serum prealbumin levels from baseline to the end of radiotherapy. Secondary objectives include evaluation of time to onset and resolution of oral mucositis, changes in body weight and other indicators of nutritional status, adverse events, and changes in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Cancer Module (EORTC QLQ-H\&N35).
The study aims to clarify whether high-protein oral nutritional supplementation can improve treatment tolerance and supportive care outcomes in patients undergoing radiotherapy for head and neck cancer.
- Conditions
- Head & Neck Cancer
- Being tested
- Hydrolyzed Whey Protein Oral Supplement, Control
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed Whey Protein Oral SupplementDietary supplement
Also called T e yi shu
A liquid oral supplement containing hydrolyzed whey protein, administered daily during the entire course of radiotherapy. Each 200mL bottle provides approximately 24g of protein. The supplement is given in addition to standard nutritional counseling and baseline dietary support. The aim is to achieve a total protein intake of 2.0 ± 0.2 g/kg/day, in accordance with cancer nutrition guidelines. This intervention is designed to evaluate whether high-dose protein supplementation reduces the incidence and severity of radiation-induced oral mucositis and improves serum prealbumin levels in head and neck cancer patients.
ControlDietary supplement
An isocaloric placebo oral supplement that matches the protein supplement in appearance, taste, volume (200mL), and frequency of administration. The placebo contains no protein or amino acids and provides equivalent caloric content through carbohydrates. It is administered daily throughout the course of radiotherapy, alongside standard nutritional counseling and baseline dietary support (20-25 kcal/kg/day and 1-1.2 g protein/kg/day). This intervention is used to control for the effects of additional caloric intake, isolating the impact of supplemental protein on clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Protein Supplementation Group | Experimental | Participants in this arm will receive an oral hydrolyzed whey protein supplement ("TeYiShu") daily, starting from the first day of radiotherapy and continuing until the end of radiotherapy. The supplement provides approximately 24 g of protein per 200 mL bottle, in addition to standard nutritional counseling and baseline nutrition support (20-25 kcal/kg/day and 1-1.2 g protein/kg/day). The total protein intake target for this group is 2.0 ± 0.2 g/kg/day, in accordance with Chinese Society of Clinical Oncology (CSCO) guidelines. The intervention aims to evaluate the effect of high-protein oral supplementation on radiation-induced oral mucositis and nutritional status in patients with head and neck cancer. Receives: Dietary Supplement: Hydrolyzed Whey Protein Oral Supplement |
| Control Arm: Placebo Group | Placebo comparator | Participants in this arm will receive an isocaloric placebo supplement that matches the experimental product in appearance, taste, volume (200mL), and administration frequency but contains no protein or amino acids. The placebo provides equivalent caloric content via carbohydrates. Participants will also receive standard nutritional counseling and baseline nutrition support (20-25 kcal/kg/day and 1-1.2 g protein/kg/day). This arm is designed to isolate the effect of additional protein supplementation by ensuring total energy intake is balanced across both groups. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Prealbumin Levels
Change in serum prealbumin (PAB) levels from baseline to the end of radiotherapy. Blood samples will be collected before the initiation of radiotherapy and at the completion of treatment. The difference will be calculated to assess the nutritional effect of the protein supplement.
Measured: Baseline to end of radiotherapy (approximately 6-8 weeks)
Incidence of Grade ≥3 Radiation-Induced Oral Mucositis
The number and proportion of participants who develop Grade 3 or higher acute oral mucositis during or within 3 months after radiotherapy, assessed according to the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria.
Measured: From the start of radiotherapy to 3 months post-radiotherapy
Secondary outcomes (7)
Time to Resolution of Grade ≥3 Oral Mucositis
The number of days from the onset of Grade ≥3 radiation-induced oral mucositis to its resolution to Grade 1 or lower, based on RTOG criteria.
Measured: From onset of mucositis to recovery or 3 months post-radiotherapy
Change in Body Weight During Radiotherapy
The difference in body weight from baseline to the end of radiotherapy, used as a proxy for nutritional status and treatment tolerance.
Measured: Baseline to end of radiotherapy (approximately 6-8 weeks)
Change in Quality of Life Score: EORTC QLQ-C30
Change in patient-reported quality of life, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), from baseline to the end of radiotherapy. Scores are linearly transformed to a 0 to 100 scale. For the global health status and functional scales, higher scores indicate better quality of life or functioning; for the symptom scales/items, higher scores indicate greater symptom burden.
Measured: Baseline, during radiotherapy, and at end of radiotherapy
Change in Head and Neck Cancer-Specific Quality of Life Score: EORTC QLQ-H&N35
Change in patient-reported head and neck cancer-specific quality of life, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Cancer Module (EORTC QLQ-H\&N35), from baseline to the end of radiotherapy. Scores are linearly transformed to a 0 to 100 scale, with higher scores indicating worse symptoms or problems.
Measured: Baseline, during radiotherapy, and at end of radiotherapy
Incidence of Adverse Events
Occurrence of treatment-related adverse events, including gastrointestinal symptoms (nausea, vomiting, diarrhea, and abdominal pain) and other acute toxicities, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: From start of radiotherapy through 3 months post-radiotherapy
Incidence of Serious Adverse Events
Serious adverse events are defined as events that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability/incapacity, or are otherwise medically important.
Measured: From start of radiotherapy through 3 months post-radiotherapy
Opioid Usage for Oral Pain Control
Total cumulative dose of opioid analgesics used by participants during the study period to control oral pain due to mucositis, recorded and analyzed as an indicator of symptom severity.
Measured: From start of radiotherapy to end of treatment (approximately 6-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ye Zhang, MD, Principal investigator, Chinese Academy of Medical Sciences, National Cancer Center, Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531563
- Sponsor's protocol ID
- NCCH5875
- Acronym
- C-Head-002
- Status last verified
- Jan 2026
- First submitted
- 31 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Protein Hydrolysate Supplementation on Radiation-Induced Severe Oral Mucositis and Prealbumin Levels in Patients With Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07531563
- Acronym / sponsor ID
- C-Head-002 / NCCH5875
- Conditions
- Head & Neck Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
This clinical trial aims to evaluate whether oral supplementation with a hydrolyzed whey protein formula ("TeYiShu") can reduce the incidence of severe radiation-induced oral mucositis and improve prealbumin levels in patients undergoing radiotherapy for head and neck squamous cell carcinoma (HNSCC). The study will compare the protein supplement to an isocaloric placebo without protein, maintaining equal caloric intake across groups. Participants will receive either the protein supplement or placebo daily throughout the course of radiotherapy. The primary outcomes are the incidence of grade ≥3 oral mucositis, assessed using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria, and changes in serum prealbumin levels. Secondary outcomes include the time to onset and resolution of mucositis, nutritional status changes, adverse events, and quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Cancer Module (EORTC QLQ-H\&N35).
Detailed description
This study is a randomized, controlled clinical trial designed to evaluate the effect of oral hydrolyzed whey protein supplementation on radiation-induced oral mucositis and nutritional status in patients with head and neck squamous cell carcinoma (HNSCC) receiving radiotherapy. Participants will be assigned to receive either a hydrolyzed whey protein formula ("TeYiShu") or an isocaloric placebo without protein during the course of radiotherapy, in addition to standard nutritional counseling and baseline nutrition support.
The primary objectives are to determine whether protein supplementation reduces the incidence of Grade 3 or higher radiation-induced oral mucositis, assessed according to the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria, and improves serum prealbumin levels from baseline to the end of radiotherapy. Secondary objectives include evaluation of time to onset and resolution of oral mucositis, changes in body weight and other indicators of nutritional status, adverse events, and changes in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Cancer Module (EORTC QLQ-H\&N35).
The study aims to clarify whether high-protein oral nutritional supplementation can improve treatment tolerance and supportive care outcomes in patients undergoing radiotherapy for head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Protein Supplementation Group | Experimental | Dietary Supplement: Hydrolyzed Whey Protein Oral SupplementParticipants in this arm will receive an oral hydrolyzed whey protein supplement ("TeYiShu") daily, starting from the first day of radiotherapy and continuing until the end of radiotherapy. The supplement provides approximately 24 g of protein per 200 mL bottle, in addition to standard nutritional counseling and baseline nutrition support (20-25 kcal/kg/day and 1-1.2 g protein/kg/day). The total protein intake target for this group is 2.0 ± 0.2 g/kg/day, in accordance with Chinese Society of Clinical Oncology (CSCO) guidelines. The intervention aims to evaluate the effect of high-protein oral supplementation on radiation-induced oral mucositis and nutritional status in patients with head and neck cancer. |
| Control Arm: Placebo Group | Placebo comparator | Dietary Supplement: ControlParticipants in this arm will receive an isocaloric placebo supplement that matches the experimental product in appearance, taste, volume (200mL), and administration frequency but contains no protein or amino acids. The placebo provides equivalent caloric content via carbohydrates. Participants will also receive standard nutritional counseling and baseline nutrition support (20-25 kcal/kg/day and 1-1.2 g protein/kg/day). This arm is designed to isolate the effect of additional protein supplementation by ensuring total energy intake is balanced across both groups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- No distant metastases (M0 stage)
- Planned to receive curative or postoperative radiotherapy (with or without concurrent therapy) with a mean oral cavity dose ≥20 Gy
- Adequate nutritional intake via oral or nasogastric route
Key exclusion criteria (11 listed)
- PG-SGA score ≥8 (indicating severe nutritional risk)
- Use of non-guideline-recommended oral care during radiotherapy
- Use of other protein supplementation products during radiotherapy
- Known allergy to components of the study product
- Acute or chronic renal insufficiency
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 |
|---|---|---|
| Hydrolyzed Whey Protein Oral SupplementAlso: T e yi shuA liquid oral supplement containing hydrolyzed whey protein, administered daily during the entire course of radiotherapy. Each 200mL bottle provides approximately 24g of protein. The supplement is given in addition to standard nutritional counseling and baseline dietary support. The aim is to achieve a total protein intake of 2.0 ± 0.2 g/kg/day, in accordance with cancer nutrition guidelines. This intervention is designed to evaluate whether high-dose protein supplementation reduces the incidence and severity of radiation-induced oral mucositis and improves serum prealbumin levels in head and neck cancer patients. | Dietary supplement | Experimental Arm: Protein Supplementation Group |
| ControlAn isocaloric placebo oral supplement that matches the protein supplement in appearance, taste, volume (200mL), and frequency of administration. The placebo contains no protein or amino acids and provides equivalent caloric content through carbohydrates. It is administered daily throughout the course of radiotherapy, alongside standard nutritional counseling and baseline dietary support (20-25 kcal/kg/day and 1-1.2 g protein/kg/day). This intervention is used to control for the effects of additional caloric intake, isolating the impact of supplemental protein on clinical outcomes. | Dietary supplement | Control Arm: Placebo Group |
Primary outcome
Change in Serum Prealbumin Levels
Time frame: Baseline to end of radiotherapy (approximately 6-8 weeks)
Change in serum prealbumin (PAB) levels from baseline to the end of radiotherapy. Blood samples will be collected before the initiation of radiotherapy and at the completion of treatment. The difference will be calculated to assess the nutritional effect of the protein supplement.
Incidence of Grade ≥3 Radiation-Induced Oral Mucositis
Time frame: From the start of radiotherapy to 3 months post-radiotherapy
The number and proportion of participants who develop Grade 3 or higher acute oral mucositis during or within 3 months after radiotherapy, assessed according to the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria.
7 secondary outcomes
Time to Resolution of Grade ≥3 Oral Mucositis
Time frame: From onset of mucositis to recovery or 3 months post-radiotherapy
Change in Body Weight During Radiotherapy
Time frame: Baseline to end of radiotherapy (approximately 6-8 weeks)
Change in Quality of Life Score: EORTC QLQ-C30
Time frame: Baseline, during radiotherapy, and at end of radiotherapy
Change in Head and Neck Cancer-Specific Quality of Life Score: EORTC QLQ-H&N35
Time frame: Baseline, during radiotherapy, and at end of radiotherapy
Incidence of Adverse Events
Time frame: From start of radiotherapy through 3 months post-radiotherapy
Incidence of Serious Adverse Events
Time frame: From start of radiotherapy through 3 months post-radiotherapy
Opioid Usage for Oral Pain Control
Time frame: From start of radiotherapy to end of treatment (approximately 6-8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Ye Zhang, MD principal investigator
Chinese Academy of Medical Sciences, National Cancer Center, Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed Whey Protein Oral Supplement in people with Head & Neck Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gulidanna Shayan, MD (+8618500369703, gldanna@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Prealbumin Levels (time frame: Baseline to end of radiotherapy (approximately 6-8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.