Study of Spermidine Capsules to Prevent Dry Mouth Caused by Radiation in Head and Neck Cancer Patients

What this Trial Is About

Researchers are evaluating spermidine as a potential way to prevent radiation-induced dry mouth xerostomia in patients undergoing radiotherapy for head and neck tumors, including nasopharyngeal carcinoma. This single-center, double-blind, randomized controlled trial compares spermidine capsules to placebo capsules to understand if spermidine can reduce this common side effect during treatment. Participants will take spermidine capsules or matching placebo capsules twice daily with meals, starting one week before radiotherapy or concurrent chemoradiotherapy and continuing until one week after completing radiotherapy. Both groups also receive routine health education, nursing care, and treatment as usual. The study maintains a quadruple-blind design to keep treatment assignments unknown. During the trial, radiation-induced xerostomia will be assessed weekly from the start of radiotherapy through three months after its completion, about 18 to 19 weeks in total. Additional measures include unstimulated salivary flow rates and quality of life questionnaires at several key time points. Participants will be monitored closely for treatment adherence and safety throughout the study period.

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