Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

NCT07040969 | Recruiting Phase 2

• 1 other identifier: 2025(1088)
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-induced Oral Mucositis

Keywords

Head & neck cancer; Radiation-induced oral mucositis; spirulina; exosome

Outcome Measures

Primary Outcomes (1)

• The incidence of severe oral mucositis (WHO grade ≥3)

  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.

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.

Secondary Outcomes (6)

• 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.

• 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 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.

• 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.

• 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.

Other Outcomes (11)

• The longitudinal dynamics of salivary microbiota

  The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.

• Taste function

  The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.

• Mouth and throat soreness (MTS) scores

  The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.

Study Arms (2)

Control group

PLACEBO COMPARATOR

Spray of placebo

Drug: Spray of placebo; Radiation: Radiotherapy

Experimental group

EXPERIMENTAL

Spray of spirulina derivatives

Drug: Spray of spirulina derivatives; Radiation: Radiotherapy

Interventions

Spray of spirulina derivatives DRUG

An oral spray formulated with purified spirulina-derived exosomes.

Experimental group

Spray of placebo DRUG

The placebo oral spray will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.

Control group

Radiotherapy RADIATION

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.

Control group; Experimental group

Eligibility Criteria

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

You may qualify if:

• Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
• Aged ≥ 18 years;
• Eastern Cooperative Oncology Group performance status of ≤2;
• Receiving definitive RT or postoperative adjuvant RT at a dose of 60- 72 Gy with/without concurrent chemotherapy;
• Sign informed consent.

You may not qualify if:

• Patients with known allergy to Spirulina components or severe allergic constitution;
• Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
• Poor oral hygiene and/or severe periodontal diseases;
• History of head and neck radiotherapy;
• Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xingchen Peng, Professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng, Professor

CONTACT

+8618980606753; pxx2014@163.com

Yiyan Pei, Doctor

CONTACT

+86 19382124852; pei_yiyan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: June 27, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)