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

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

Overview

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.

Interventions

• 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/kg/day, in accordance with cancer nutrition guidelines. This intervention is designed to evaluate whether high-dose protein supplementation reduces the incidenc
• Dietary supplement 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/kg/day and 1-1.2 g protein/kg/day). This intervention is used to control for the effects of additi

Primary outcome measures

• Change in Serum Prealbumin Levels [Time frame: Baseline to end of radiotherapy (approximately 6-8 weeks)]
• Incidence of Grade ≥3 Radiation-Induced Oral Mucositis [Time frame: From the start of radiotherapy to 3 months post-radiotherapy]

Secondary outcome measures (7)

• 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07531563 · NCCH5875

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗