A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)

Официальное название

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

Обзор

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).

Подробное описание

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).

The experimental group took spermidine capsules twice a day with meals, while the placebo group took placebo capsules twice a day with meals. The appearance and taste of the placebo and spermidine were kept the same.

The primary end point was radiation-induced xerostomia, as determined by the Xerostomia Questionnaire in which a higher score indicates worse radiation-induced xerostomia.

Вмешательства

• Препарат Spermidine
  As a member of the polyamine family, spermidine is a trivalent cationic compound found in eukaryotic cells. It interacts with polyanions such as nucleic acids, proteins, and ATP through electrostatic binding, thereby maintaining genomic DNA stability, regulating gene transcription and translation, and modulating autophagy, apoptosis, oxidative stress, angiogenesis, and intercellular communication. Spermidine is indispensable for cell division and proliferation.
• Препарат Spermidine simulants
  Patients in control group were treated with Spermidine simulants, and its use method and use time are the same as intervention group.

Первичные конечные точки

• Radiation-induced xerostomia [Срок оценки: Radiation-induced xerostomia will be assessed weekly from the start of radiotherapy to 3 months after its completion, totaling approximately 18-19 weeks.]

Вторичные конечные точки (3)

• Unstimulated salivary flow rate [Срок оценки: Radiation-induced xerostomia will be assessed weekly from the start of radiotherapy to 3 months after its completion, totaling approximately 18-19 weeks.]
• Quality of life (EORTC QLQ-C30) [Срок оценки: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy.]
• Quality of life (EORTC QLQ-H&N35) [Срок оценки: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 \[pilocarpine, cevimeline\], 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.
• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• West China Hospital of Sichuan University — Чэнду

Публикации

• Min Y, Gao K, Liu Y, Dai L, Peng X. Oral Spermidine Supplementation Preserves Submandibular Gland Function After Radiotherapy: Mechanistic Insights and Use in a Phase II Randomized Clinical Trial. MedComm (2020). 2026 Jul 15;7(8):e70862. doi: 10.1002/mco2.70862. eCollection 2026 Aug. PMID 42460130

Идентификаторы

NCT: NCT07035626 · 2023-2055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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