Radiation-induced XerostomiaPhase 1/2NCT07035626
A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)
A Phase 1/2 study testing Spermidine and Spermidine simulants in people with Radiation-induced Xerostomia, run by West China Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation-induced Xerostomia
- What is being tested?
- Spermidine and Spermidine simulants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 8 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Poor compliance.
- Pregnant or breastfeeding.
- Other patients deemed unsuitable by the investigator (e.g., concurrent severe comorbidities, mental disability, or severe emotional/psychiatric disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Xingchen Peng, PhD, 18980606753
About this study
Official title: A Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia
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).
Read the detailed description
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.
- Conditions
- Radiation-induced Xerostomia
- Being tested
- Spermidine, Spermidine simulants
- Keywords
- Head and Neck Malignant Tumors, Radiation-induced xerostomia, Spermidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpermidineDrug
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 simulantsDrug
Patients in control group were treated with Spermidine simulants, and its use method and use time are the same as intervention group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Spermidine simulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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
The assessment method for unstimulated salivary flow rate is the average secretion of unstimulated saliva over 5 minutes, measured in milliliters per minute.
Measured: 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)
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start25 Jun 2025
- Primary completion8 Jun 2026 (estimated)
- Study completion8 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation-induced XerostomiaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035626
- Sponsor's protocol ID
- 2023-2055
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Min Y, Gao K, Liu Y, Dai L, Peng X. Oral Spermidine Supplementation Preserves Submandibular Gland Function After Radiotherapy: Mechanistic Insights and Use in a Phase II Randomized Clinical Trial. MedComm (2020). 2026 Jul 15;7(8):e70862. doi: 10.1002/mco2.70862. eCollection 2026 Aug.
PubMed 42460130
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia
- ClinicalTrials.gov ID
- NCT07035626
- Acronym / sponsor ID
- 2023-2055
- Conditions
- Radiation-induced Xerostomia
- Keywords
- Head and Neck Malignant Tumors, Radiation-induced xerostomia, Spermidine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 8 Jun 2026 (estimated)
- Study completion
- 8 Jun 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort | Experimental | Drug: SpermidineOne 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. |
| Control Cohort | Placebo comparator | Drug: Spermidine simulantsOne 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpermidineAs 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. | Drug | Treatment Cohort |
| Spermidine simulantsPatients in control group were treated with Spermidine simulants, and its use method and use time are the same as intervention group. | Drug | Control Cohort |
Primary outcome
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.
The primary end point was radiation-induced xerostomia, as determined by the Xerostomia Questionnaire in which a higher score indicates worse radiation-induced xerostomia .
3 secondary outcomes
Unstimulated salivary flow rate
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)
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 42460130Min Y, Gao K, Liu Y, Dai L, Peng X. Oral Spermidine Supplementation Preserves Submandibular Gland Function After Radiotherapy: Mechanistic Insights and Use in a Phase II Randomized Clinical Trial. MedComm (2020). 2026 Jul 15;7(8):e70862. doi: 10.1002/mco2.70862. eCollection 2026 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Spermidine and Spermidine simulants in people with Radiation-induced Xerostomia, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng (18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07035626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.