Radiation-induced Oral MucositisPhase 1/2RIOMNCT06939582
Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis
A Phase 1/2 study testing Hydroxychloroquine Sulfate Tablets in people with Radiation-induced Oral Mucositis, run by Xingchen Peng at 1 site in China.
Trial summary
Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation-induced Oral Mucositis
- What is being tested?
- Hydroxychloroquine Sulfate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2024to 20 Jun 2025
- 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 pathologically diagnosed with non-metastatic head and neck malignant tumors
- Aged 18-80 years
- Eastern Cooperative Oncology Group performance status of ≤2
- Planning to receive definitive RT or postoperative adjuvant RT
- Normal liver, kidney and bone marrow function
- Sign informed consent
Who cannot join
- Those who are known to be allergic to 4-aminoquinoline compounds or have more serious allergic constitution
- Had a history of head and neck radiotherapy
- Patients with non head and neck parts in the radiotherapy area
- Poor oral hygiene or severe periodontitis
- Suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy
- Recently taking or taking diuretics or other drugs known to interact with hydroxychloroquine sulfate tablets
- Retinopathy
- Other patients (combined with any serious other diseases) who the investigator believes are not suitable for participation in this study
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
Department of Radiation Oncology
Chengdu, Sichuan, 610000
Professor, Xingchen Peng, 18980754549, 812471898@qq.com
About this study
Official title: A Single Center, Open Label Phase II Clinical Trial of Hydroxychloroquine Sulfate Tablets for the Treatment of Radiation Stomatitis and Taste Disturbance in Intensity Modulated Radiotherapy for Head and Neck Cancer
Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy
- Conditions
- Radiation-induced Oral Mucositis
- Being tested
- Hydroxychloroquine Sulfate Tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Sulfate TabletsDrug
the trial group use the hydroxychloroquine sulfate tablets (200mg/time, bid)
PlaceboOther
the control group use the Placebo
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | use the placebo Receives: Other: Placebo |
| trial group | Experimental | use the hydroxychloroquine sulfate tablets Receives: Drug: Hydroxychloroquine Sulfate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
the WHO grade of RIOM
use the WHO Oral Toxicity Scale to evaluate the WHO grade of RIOM. WHO O grade: no representation of RIOM; WHO 1 grade: soreness and erythema; WHO 2 grade: erythema, ulcers and ability to eat solids; WHO 3 grade: ulcers, requiring liquid diet; WHO 4 grade: alimentation not possible. The higher scores mean a worse outcome.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start22 Dec 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion20 Jun 2025 (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 Oral MucositisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xingchen Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939582
- Sponsor's protocol ID
- 20241413
- Acronym
- RIOM
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schrezenmeier E, Dorner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020 Mar;16(3):155-166. doi: 10.1038/s41584-020-0372-x. Epub 2020 Feb 7.
PubMed 32034323
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label Phase II Clinical Trial of Hydroxychloroquine Sulfate Tablets for the Treatment of Radiation Stomatitis and Taste Disturbance in Intensity Modulated Radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06939582
- Acronym / sponsor ID
- RIOM / 20241413
- Conditions
- Radiation-induced Oral Mucositis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Xingchen PengUniversity, hospital or other
- Study start
- 22 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 23 Apr 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.
Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Placebouse the placebo |
| trial group | Experimental | Drug: Hydroxychloroquine Sulfate Tabletsuse the hydroxychloroquine sulfate tablets |
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 pathologically diagnosed with non-metastatic head and neck malignant tumors
- Aged 18-80 years
- Eastern Cooperative Oncology Group performance status of ≤2
- Planning to receive definitive RT or postoperative adjuvant RT
- Normal liver, kidney and bone marrow function
Key exclusion criteria (8 listed)
- Those who are known to be allergic to 4-aminoquinoline compounds or have more serious allergic constitution
- Had a history of head and neck radiotherapy
- Patients with non head and neck parts in the radiotherapy area
- Poor oral hygiene or severe periodontitis
- Suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy
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 |
|---|---|---|
| Hydroxychloroquine Sulfate Tabletsthe trial group use the hydroxychloroquine sulfate tablets (200mg/time, bid) | Drug | trial group |
| Placebothe control group use the Placebo | Other | Control group |
Primary outcome
the WHO grade of RIOM
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
use the WHO Oral Toxicity Scale to evaluate the WHO grade of RIOM. WHO O grade: no representation of RIOM; WHO 1 grade: soreness and erythema; WHO 2 grade: erythema, ulcers and ability to eat solids; WHO 3 grade: ulcers, requiring liquid diet; WHO 4 grade: alimentation not possible. The higher scores mean a worse outcome.
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 29 Apr 2025.
- Background: PubMed 32034323Schrezenmeier E, Dorner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020 Mar;16(3):155-166. doi: 10.1038/s41584-020-0372-x. Epub 2020 Feb 7.
- 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 Hydroxychloroquine Sulfate Tablets in people with Radiation-induced Oral Mucositis, run by Xingchen Peng 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 8 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 29 Apr 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 Peng xingchen Professor (+86 1880606753, pxx2014@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the WHO grade of RIOM (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?
On the ClinicalTrials.gov record for NCT06939582, 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 29 Apr 2025.