Head and Neck Squamous Cell CarcinomaPhase 2NCT05918224
Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy
A Phase 2 study testing Streptococcus salivarius K12 and Streptococcus salivarius K12 simulants in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Streptococcus salivarius K12 and Streptococcus salivarius K12 simulants
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 non-metastatic head and neck malignant tumor diagnosed by histopathology;
- Aged 18 to 80 years;
- Systemic functional status Eastern Cooperative Oncology Group (ECOG) (Appendix 1) rating ≤2;
- Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
- Sign the informed consent
Who cannot join
- Patients with known allergy to probiotic or severe allergic constitution;
- Using antibiotics/antifungal drugs within 1 month or using antimicrobial mouthwash within 1 week before the study;
- Poor oral hygiene and/or severe periodontal diseases;
- Any previous RT to the head and neck region;
- Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy for Head and Neck Tumor: A Randomized, Placebo-Controlled, Double-Blind Trial
To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.
Read the detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of Streptococcus salivarius K12 in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Streptococcus salivarius K12 can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy.
Participants will be instructed to suck a Streptococcus salivarius K12 or placebo lozenge three times daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour.
Researchers will compare Streptococcus salivarius K12 group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Streptococcus salivarius K12, Streptococcus salivarius K12 simulants
- Keywords
- head and neck squamous cell carcinoma, nasopharyngeal carcinoma, oral mucositis, Streptococcus salivarius K12
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Nasopharyngeal Carcinoma, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus salivarius K12Drug
Also called OralBiotic BLIS K12 (NOW Foods, USA)
The patients in intervention group were treated with Streptococcus salivarius K12 lozenges three times a day after gargling from the first day of radiotherapy up to 1 week after the end of treatment. Streptococcus salivarius K12 is dissolved in the mouth and then swallowed.
Streptococcus salivarius K12 simulantsDrug
Patients in control group were treated with Streptococcus salivarius K12 simulants, and its use method and use time are the same as intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | S. salivarius K12 group: The S. salivarius K12 lozenges (NOW Foods, USA) contained not less than 1×109 CFU viable cells of S. salivarius K12 as the active ingredient. The S. salivarius K12 lozenges were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day). Receives: Drug: Streptococcus salivarius K12 |
| Placebo group | Placebo comparator | Placebo group: Placebo lozenges contained sugar and starch used as excipients in the active formulation. The placebo lozenge were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day). Receives: Drug: Streptococcus salivarius K12 simulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Severe Oral mucositis (WHO grade ≥3)
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Secondary outcomes (9)
Taste function
Electrogustometer test and taste strips test.
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, 3, 6, 9 and 12 months after the end of radiotherapy
Xerostomia
Patients self-rated xerostomia according to summated xerostomia inventory (SXI), and researchers measured saliva flow rates.
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, 3, 6, 9 and 12 months after the end of radiotherapy
functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire.
FACT- H\&N quality of life questionnaire.
Measured: 1 week before radiotherapy; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); ; and 1, 3, 6, 9 and 12 months after the end of radiotherapy
Adverse events
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
Measured: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks
The duration of Severe Oral mucositis (WHO grade ≥3)
The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM. Patients without observed SOM were assigned a duration of 0 days.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy
The time to onset of Severe Oral mucositis (WHO grade ≥3)
Time from the first day of radiotherapy to the first determination of SOM. Patients without observed SOM were assigned onset days of 6 or 6.5 weeks.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy
The number of patients who missed five or more consecutive radiation fractions.
The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.
Measured: The time period is the period from the start of radiotherapy to the completion of radiotherapy
Mouth and throat soreness (MTS) scores
Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms.
Measured: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6 1/2 weeks
Oral activities scores
Patients report the degree to the impact of MTS on oral activities (including swallowing, drinking, eating, talking, sleeping) (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms.
Measured: The time period is the period from the start of radiotherapy to the completion of radiotherapy. The evaluation period is approximately 6 weeks and 6 1/2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Jan 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918224
- Sponsor's protocol ID
- ChiCTR2100054689
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy for Head and Neck Tumor: A Randomized, Placebo-Controlled, Double-Blind Trial
- ClinicalTrials.gov ID
- NCT05918224
- Acronym / sponsor ID
- ChiCTR2100054689
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck squamous cell carcinoma, nasopharyngeal carcinoma, oral mucositis, Streptococcus salivarius K12
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 26 Jun 2023 (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.
To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.
Detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of Streptococcus salivarius K12 in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Streptococcus salivarius K12 can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy.
Participants will be instructed to suck a Streptococcus salivarius K12 or placebo lozenge three times daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour.
Researchers will compare Streptococcus salivarius K12 group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.
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 |
|---|---|---|
| Experimental group | Experimental | Drug: Streptococcus salivarius K12S. salivarius K12 group: The S. salivarius K12 lozenges (NOW Foods, USA) contained not less than 1×109 CFU viable cells of S. salivarius K12 as the active ingredient. The S. salivarius K12 lozenges were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day). |
| Placebo group | Placebo comparator | Drug: Streptococcus salivarius K12 simulantsPlacebo group: Placebo lozenges contained sugar and starch used as excipients in the active formulation. The placebo lozenge were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with non-metastatic head and neck malignant tumor diagnosed by histopathology;
- Aged 18 to 80 years;
- Systemic functional status Eastern Cooperative Oncology Group (ECOG) (Appendix 1) rating ≤2;
- Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
- Sign the informed consent
Key exclusion criteria (5 listed)
- Patients with known allergy to probiotic or severe allergic constitution;
- Using antibiotics/antifungal drugs within 1 month or using antimicrobial mouthwash within 1 week before the study;
- Poor oral hygiene and/or severe periodontal diseases;
- Any previous RT to the head and neck region;
- Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
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 |
|---|---|---|
| Streptococcus salivarius K12Also: OralBiotic BLIS K12 (NOW Foods, USA)The patients in intervention group were treated with Streptococcus salivarius K12 lozenges three times a day after gargling from the first day of radiotherapy up to 1 week after the end of treatment. Streptococcus salivarius K12 is dissolved in the mouth and then swallowed. | Drug | Experimental group |
| Streptococcus salivarius K12 simulantsPatients in control group were treated with Streptococcus salivarius K12 simulants, and its use method and use time are the same as intervention group. | Drug | Placebo group |
Primary outcome
The incidence of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.
9 secondary outcomes
Taste function
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, 3, 6, 9 and 12 months after the end of radiotherapy
Xerostomia
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, 3, 6, 9 and 12 months after the end of radiotherapy
functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire.
Time frame: 1 week before radiotherapy; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); ; and 1, 3, 6, 9 and 12 months after the end of radiotherapy
Adverse events
Time frame: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks
The duration of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
The time to onset of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
The number of patients who missed five or more consecutive radiation fractions.
Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy
Mouth and throat soreness (MTS) scores
Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6 1/2 weeks
Oral activities scores
Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy. The evaluation period is approximately 6 weeks and 6 1/2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- 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. This study is not recruiting at the moment.
Xingchen Peng principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Streptococcus salivarius K12 and Streptococcus salivarius K12 simulants in people with Head and Neck Squamous Cell Carcinoma, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 5 Feb 2024. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Severe Oral mucositis (WHO grade ≥3) (time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2024.