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Prevention study for Radiation-induced Xerostomia
Official title A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
ClinicalTrials.gov ID: NCT07035626
What this study is testing
What is Spermidine?
Spermidine is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for radiation-induced xerostomia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-center, double-blind, randomized controlled clinical trial with placebo as the control, aiming to evaluate the effectiveness of spermidine in preventing radiation-induced xerostomia during radiotherapy for head and neck tumors (including nasopharyngeal carcinoma).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients with histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma).
- Aged ≥18 years and ≤80 years.
- ECOG performance status score ≤2.
- Receiving radical radiotherapy or concurrent chemoradiotherapy with radiation dose \>50 Gy, where: Both parotid glands receive an average dose ≥25...
- 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.
You likely can't join if
- History of xerostomia, Sjögren's syndrome, or other known systemic diseases predisposing to dry mouth.
- Wheat allergy or gluten intolerance.
- Suspected or confirmed physical occlusion of bilateral salivary gland ducts.
- Prior history of head and neck radiotherapy.
- 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...
- Poor oral hygiene or severe periodontitis.
See the full eligibility criteria
- Patients with histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma).
- Aged ≥18 years and ≤80 years.
- ECOG performance status score ≤2.
- 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.
- 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.
- Signed informed consent form.
- History of xerostomia, Sjögren's syndrome, or other known systemic diseases predisposing to dry mouth.
- Wheat allergy or gluten intolerance.
- Suspected or confirmed physical occlusion of bilateral salivary gland ducts.
- Prior history of head and neck radiotherapy.
- 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]...
- Poor oral hygiene or severe periodontitis.
- Poor compliance.
- Pregnant or breastfeeding.
- Other patients deemed unsuitable by the investigator (e.g., concurrent severe comorbidities, mental disability, or severe emotional/psychiatric disorders).
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.