Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Re… (NCT07531563) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy
504 participantsStarted 2026-07-01
Plain-language 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). 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Serum Prealbumin Levels
Timeframe: Baseline to end of radiotherapy (approximately 6-8 weeks)
2
Incidence of Grade ≥3 Radiation-Induced Oral Mucositis
Timeframe: From the start of radiotherapy to 3 months post-radiotherapy
Trial details
NCT IDNCT07531563
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences