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

NCT07035626 | Recruiting Phase 1

• 1 other identifier: 2023-2055
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Radiation-induced Xerostomia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Radiation-induced xerostomia

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

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

Secondary Outcomes (3)

• Unstimulated salivary flow rate

  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)

  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)

  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.

Study Arms (2)

Treatment Cohort

EXPERIMENTAL

One week before the initiation of radiotherapy or concurrent chemoradiotherapy, in addition to routine health education, nursing care, and treatment, participants will start taking spermidine capsules twice daily with meals, continuing until one week after the completion of radiotherapy.

Drug: Spermidine

Control Cohort

PLACEBO COMPARATOR

One week before the initiation of radiotherapy or concurrent chemoradiotherapy, in addition to routine health education, nursing care, and treatment, participants will start taking placebo capsules twice daily with meals, continuing until one week after the completion of radiotherapy.

Drug: Spermidine simulants

Interventions

Spermidine DRUG

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.

Treatment Cohort

Spermidine simulants DRUG

Patients in control group were treated with Spermidine simulants, and its use method and use time are the same as intervention group.

Control Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 (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).

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Interventions

Spermidine

Intervention Hierarchy (Ancestors)

Putrescine; Biogenic Polyamines; Biogenic Amines; Amines; Organic Chemicals; Polyamines

Central Study Contacts

Xingchen Peng

CONTACT

18980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 25, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): June 8, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)