Actively Recruiting
A Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia
Led by West China Hospital · Updated on 2025-06-26
58
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating spermidine as a potential way to prevent radiation-induced dry mouth (xerostomia) in patients undergoing radiotherapy for head and neck tumors, including nasopharyngeal carcinoma. This single-center, double-blind, randomized controlled trial compares spermidine capsules to placebo capsules to understand if spermidine can reduce this common side effect during treatment. Participants will take spermidine capsules or matching placebo capsules twice daily with meals, starting one week before radiotherapy or concurrent chemoradiotherapy and continuing until one week after completing radiotherapy. Both groups also receive routine health education, nursing care, and treatment as usual. The study maintains a quadruple-blind design to keep treatment assignments unknown. During the trial, radiation-induced xerostomia will be assessed weekly from the start of radiotherapy through three months after its completion, about 18 to 19 weeks in total. Additional measures include unstimulated salivary flow rates and quality of life questionnaires at several key time points. Participants will be monitored closely for treatment adherence and safety throughout the study period.
CONDITIONS
Brief Title
A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
- Aged 18 years and older up to 80 years
- ECOG performance status score of 2 or less
- Receiving radical radiotherapy or concurrent chemoradiotherapy with radiation dose over 50 Gy, meeting specified parotid gland dose requirements
- Adequate blood routine parameters: hemoglobin at least 100 g/L, platelets at least 80×10⁹/L, white blood cell count at least 3.0×10⁹/L, absolute neutrophil count at least 1.5×10⁹/L
- Signed informed consent form
You will not qualify if you...
- History of xerostomia, Sjögren's syndrome, or other systemic diseases causing dry mouth
- Wheat allergy or gluten intolerance
- Suspected or confirmed blockage of bilateral salivary gland ducts
- Prior radiotherapy to the head and neck
- Use of medications or supplements affecting salivary function within the past 30 days or planned use during the study
- Poor oral hygiene or severe periodontitis
- Poor compliance
- Pregnant or breastfeeding
- Other conditions deemed unsuitable by the investigator, such as severe comorbidities or psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants take spermidine or placebo capsules twice daily with meals starting one week before radiotherapy and continuing until one week after radiotherapy ends.
Weekly visits during radiotherapy
Duration - Approximately 12 weeks
Participants are monitored for radiation-induced xerostomia and quality of life for up to 3 months after completing radiotherapy.
Weekly visits for up to 3 months after radiotherapy
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
X
Xingchen Peng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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