[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633813":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":32,"responsibleParty":44,"collaborators":32,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":32,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":32,"overallStatus":66,"whyStopped":32,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":32},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002Fkg\u002Fday and 1-1.2 g protein\u002Fkg\u002Fday). The total protein intake target for this group is 2.0 ± 0.2 g\u002Fkg\u002Fday, 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.",[13],"Dietary Supplement: Hydrolyzed Whey Protein Oral Supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"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\u002Fkg\u002Fday and 1-1.2 g protein\u002Fkg\u002Fday). This arm is designed to isolate the effect of additional protein supplementation by ensuring total energy intake is balanced across both groups.",[19],"Dietary Supplement: Control",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Hydrolyzed Whey Protein Oral Supplement","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\u002Fkg\u002Fday, 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.",[9],[27],"T e yi shu",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Control","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\u002Fkg\u002Fday and 1-1.2 g protein\u002Fkg\u002Fday). This intervention is used to control for the effects of additional caloric intake, isolating the impact of supplemental protein on clinical outcomes.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Ye Zhang, MD","Chinese Academy of Medical Sciences, National Cancer Center, Cancer Hospital","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Gulidanna Shayan, MD","CONTACT","+8618500369703","gldanna@163.com",{"type":45,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100633813","protein-supplementation-for-radiation--induced-oral-mucositis-in-head-and-neck-cancer-patients-receiving-radiotherapy-100633813",false,"NCT07531563","Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy","Effect of Oral Protein Hydrolysate Supplementation on Radiation-Induced Severe Oral Mucositis and Prealbumin Levels in Patients With Head and Neck Squamous Cell Carcinoma","C-Head-002","Inclusion Criteria:\n\n* Age 18-75 years\n* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx\n* No distant metastases (M0 stage)\n* Planned to receive curative or postoperative radiotherapy (with or without concurrent therapy) with a mean oral cavity dose ≥20 Gy\n* Adequate nutritional intake via oral or nasogastric route\n* Willingness to follow NCCN\u002FMASCC guidelines for oral care during radiotherapy\n* Signed written informed consent\n\nExclusion Criteria:\n\n* PG-SGA score ≥8 (indicating severe nutritional risk)\n* Use of non-guideline-recommended oral care during radiotherapy\n* Use of other protein supplementation products during radiotherapy\n* Known allergy to components of the study product\n* Acute or chronic renal insufficiency\n* Severe hepatic impairment\n* Congestive heart failure requiring fluid restriction\n* Gastrointestinal disorders affecting amino acid absorption (e.g., atrophic gastritis, bowel obstruction, inflammatory bowel disease)\n* Conditions increasing aspiration risk (e.g., abdominal compartment syndrome, gastric emptying disorders)\n* Inborn errors of amino acid metabolism\n* Cognitive impairment, psychiatric illness, or other factors affecting compliance or informed consent","ALL","18 Years","75 Years",{"count":58,"type":59},504,"ESTIMATED","INTERVENTIONAL",[62],"NA","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).",[65],"Head & Neck Cancer","NOT_YET_RECRUITING","2026-04-12",{"date":69,"type":70},"2026-04-15","ACTUAL",{"date":72,"type":59},"2026-07-01",{"date":74,"type":59},"2027-12-31",{"name":5,"class":6}]