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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Xingchen Peng
pxx2014@163.com
18980606753
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2026-06-08
Participants
Target number of participants: 58
Treatments
Experimental: Treatment Cohort
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.
Placebo_comparator: Control Cohort
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.
Related Therapeutic Areas
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov