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

ConditionRadiation-induced Xerostomia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWest China Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Treatment CohortExperimental treatment 1 intervention
Group B: Control CohortPlacebo comparator 1 intervention

Trial outcomes

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 .

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.

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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