Radiation-induced Oral Mucositis
Conditions
Keywords
Head & neck cancer, Radiation-induced oral mucositis, spirulina, exosome
Brief summary
To evaluate the efficacy and safety of Spirulina-Derived Product for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.
Detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of spirulina-derived product in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The study primarily aims to address two questions: (1) whether spirulina-derived product can effectively prevent and mitigate radiation-induced oral mucositis, and (2) whether its use is associated with adverse events in patients undergoing radiotherapy. Participants will be instructed to orally administer the spirulina-derived product or placebo spray four times daily, starting from the first day of radiotherapy (RT) and continuing throughout the RT course. After each spray application, patients must refrain from eating, drinking, or performing oral hygiene activities for at least 1 hour to maximize mucosal contact time of the intervention. The study will compare the spirulina-derived product group with the placebo group to determine the potential benefits of this spirulina-based intervention in preventing and managing radiotherapy-related oral mucositis.
Interventions
DRUGSpray of spirulina derivatives
An oral spray formulated with purified spirulina-derived exosomes.
DRUGSpray of placebo
The placebo oral spray will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.
RADIATIONRadiotherapy
One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; 2. Aged ≥ 18 years; 3. Eastern Cooperative Oncology Group performance status of ≤2; 4. Receiving definitive RT or postoperative adjuvant RT at a dose of 60- 72 Gy with/without concurrent chemotherapy; 5. Sign informed consent.
Exclusion criteria
1. Patients with known allergy to Spirulina components or severe allergic constitution; 2. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study; 3. Poor oral hygiene and/or severe periodontal diseases; 4. History of head and neck radiotherapy; 5. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of severe oral mucositis (WHO grade ≥3) | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks. | Oral mucositis is assessed by trained radiotherapists according to World Health Organization (WHO) oral toxicity Scale.The WHO Oral Toxicity Scale categorizes oral mucositis into grades 0-4, with the higher the grade the more severe the patient's oral mucositis. Grade 0 means that the oral mucosa is normal and the patient has no symptoms or signs; grade 1 means that the mucosa is erythematous with or without pain and does not interfere with eating; grade 2 means that the mucosa is erythematous and ulcerated, but still able to eat solid food; grade 3 means that the mucosa is severely ulcerated with extensive erythema and unable to eat solid food; and grade 4 means that the ulcers of the mucosa are fused together into a sheet, and their severity is so severe that it is not possible to eat. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to onset of severe oral mucositis (WHO grade ≥3) | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. | Time from the first day of radiotherapy to the first determination of SOM. |
| The duration of severe oral mucositis (WHO grade ≥3) | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. | The first determination of SOM to the first instance of non-severe OM (WHO grade \<3), without a subsequent instance of SOM. |
| The incidence of any-grade oral mucositis (OM) | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. | Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale. |
| The time to onset of any-grade oral mucositis (OM) | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. | Time from the first day of radiotherapy to the first determination of OM. |
| The duration of any-grade oral mucositis (OM) | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. | The first determination of OM to the first instance of non-OM, without a subsequent instance of OM. |
| Adverse events | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXingchen Peng, Professor
West China Hospital
Outcome results
None listed