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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Xingchen Peng
• Email: pxx2014@163.com
• Phone: 18980606753

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sialendoscopy versus photobiomodulation to prevent radiation‑related dry mouth

  This trial compares a minimally invasive duct‑clearing procedure (sialendoscopy) with a light‑based laser therapy (photobiomodulation) to try to prevent dry mouth in adults receiving radiation for head and neck cancer.

  Recruiting Alexandria University · Alexandria · NCT07476209

• Treatment for dry mouth caused by radiation therapy

  This study is testing a new treatment for dry mouth caused by radiation therapy to see if it can help adults who haven't found relief from other options.

  Recruiting at 5 sites Phase 1/2 RiboX Therapeutics Ltd. · Palo Alto, California and 4 other locations · NCT06714253

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.