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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
58
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.
Patients in control group were treated with Spermidine simulants, and its use method and use time are the same as intervention group.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGRadiation-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 .
Time frame: Radiation-induced xerostomia will be assessed weekly from the start of radiotherapy to 3 months after its completion, totaling approximately 18-19 weeks.
Unstimulated salivary flow rate
The assessment method for unstimulated salivary flow rate is the average secretion of unstimulated saliva over 5 minutes, measured in milliliters per minute.
Time frame: 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)
Quality of life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: 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)
Quality of life will be assessed using the Head and Neck Cancer Module (EORTC QLQ-H\&N35).
Time frame: 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.
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