Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy

NCT07531563 | Not Yet Recruiting DMC

• 1 other identifier: NCCH5875
• Study Type: interventional
• Target: 504
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Head & Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the start of radiotherapy to 3 months post-radiotherapy

Secondary Outcomes (7)

• Time to Resolution of Grade ≥3 Oral Mucositis

  From onset of mucositis to recovery or 3 months post-radiotherapy

• Change in Body Weight During Radiotherapy

  Baseline to end of radiotherapy (approximately 6-8 weeks)

• Change in Quality of Life Score: EORTC QLQ-C30

  Baseline, during radiotherapy, and at end of radiotherapy

• Change in Head and Neck Cancer-Specific Quality of Life Score: EORTC QLQ-H&N35

  Baseline, during radiotherapy, and at end of radiotherapy

• Incidence of Adverse Events

  From start of radiotherapy through 3 months post-radiotherapy

Study Arms (2)

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.

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.

Dietary Supplement: Control

Interventions

Hydrolyzed Whey Protein Oral Supplement DIETARY_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/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.

Also known as: T e yi shu

Experimental Arm: Protein Supplementation Group

Control DIETARY_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.

Control Arm: Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Ye Zhang, MD

  Chinese Academy of Medical Sciences, National Cancer Center, Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gulidanna Shayan, MD

CONTACT

+8618500369703; gldanna@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share