Spermidine to prevent radiation-induced dry mouth in head and neck cancer

A Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia

This trial will try if taking spermidine capsules twice daily during radiotherapy prevents dry mouth in adults with head and neck cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07035626 on ClinicalTrials.gov

What this trial studies

This single-center, double-blind, randomized, placebo-controlled Phase 1/2 trial at West China Hospital tests oral spermidine given twice daily with meals versus matched placebo in patients undergoing radical radiotherapy or concurrent chemoradiotherapy for head and neck squamous cell carcinoma (including nasopharyngeal carcinoma). Participants are randomized to spermidine or placebo and followed through treatment with xerostomia measured by the Xerostomia Questionnaire as the primary endpoint. Key eligibility includes ages 18–80, ECOG ≤2, and planned radiotherapy with specified parotid dose thresholds; patients with prior head and neck radiotherapy or pre-existing causes of dry mouth are excluded. The study aims to determine whether spermidine can reduce severity of radiation-induced xerostomia compared with placebo.

Who should consider this trial

Good fit: Adults aged 18–80 with histologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) who are scheduled for radical radiotherapy or concurrent chemoradiotherapy meeting the study parotid dose criteria, have ECOG ≤2, adequate blood counts, and can consent are ideal candidates.

Not a fit: Patients with pre-existing xerostomia, Sjögren's syndrome, salivary gland duct obstruction, prior head and neck radiotherapy, or other conditions causing dry mouth (and those with wheat/gluten intolerance if relevant to the formulation) are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, spermidine could reduce radiation-induced dry mouth and improve quality of life, eating, and oral health for patients receiving head and neck radiotherapy.

How similar studies have performed: This is a relatively novel clinical application of spermidine with limited prior clinical data specifically for preventing radiation-induced xerostomia, though spermidine has been studied in other biological contexts.

Eligibility criteria

Inclusion Criteria:

1. Patients with histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma).
2. Aged ≥18 years and ≤80 years.
3. ECOG performance status score ≤2.
4. Receiving radical radiotherapy or concurrent chemoradiotherapy with radiation dose \>50 Gy, where: Both parotid glands receive an average dose ≥25 Gy; or one gland receives a dose ≥25 Gy and the other receives any dose.
5. Blood routine parameters: hemoglobin ≥100 g/L, platelets ≥80×10⁹/L, white blood cell count ≥3.0×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L.
6. Signed informed consent form.

Exclusion Criteria:

1. History of xerostomia, Sjögren's syndrome, or other known systemic diseases predisposing to dry mouth.
2. Wheat allergy or gluten intolerance.
3. Suspected or confirmed physical occlusion of bilateral salivary gland ducts.
4. Prior history of head and neck radiotherapy.
5. Use of any medications or herbal supplements that may affect salivary function within the past 30 days, or planned/final use during the study period (e.g., amifostine, cholinergic agonists \[pilocarpine, cevimeline\], certain β-adrenergic antagonists, anticholinergic drugs, or other known salivary function modifiers). If using saliva substitutes, patients must abstain from use for at least 24 hours prior to saliva and questionnaire data collection.
6. Poor oral hygiene or severe periodontitis.
7. Poor compliance.
8. Pregnant or breastfeeding.
9. Other patients deemed unsuitable by the investigator (e.g., concurrent severe comorbidities, mental disability, or severe emotional/psychiatric disorders).

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Xingchen Peng

Conditions Radiation-induced Xerostomia; Head and Neck Malignant Tumors; Radiation-induced xerostomia; Spermidine