Oral MucositisPhase 2NCT02885376
Study of Dentoxol® Mouthrinse for Oral Mucositis
A Phase 2 study testing Dentoxol in people with Oral Mucositis, run by Ingalfarma SpA at 3 sites in Chile.
Trial summary
The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Dentoxol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 3 sitesChile
- Study dates
- Nov 2014to Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned to receive radiation therapy for cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx, with or without concomitant chemotherapy.
- Planned to receive at least 5000cGy radiation therapy to at least 2 of 12 pre-specified areas in the oral cavity
Who cannot join
- Unable to give written informed consent
- Known allergy/intolerance to any component of the study rinse or placebo
- Planning to use any contraindicated medications during the study period (pain medications are allowed)
- Age below 18 years
- Pregnant or nursing (If the patient is a woman of childbearing potential, a pregnancy test must be performed within fourteen days before enrollment in the study)
Trial locations and contacts
3 sites in 1 country.
Chile3 sites
Clinica IRAM
Santiago
Fundación Arturo López Pérez
Santiago
Instituto Nacional del Cáncer
Santiago
About this study
Official title: Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer
The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.
- Conditions
- Oral Mucositis
- Being tested
- Dentoxol, Placebo
- Keywords
- Mucositis
- Medical subject headings
- Stomatitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DentoxolDevice
Mouthrinse
PlaceboDevice
Mouthrinse
| Study group | Role | What they receive |
|---|---|---|
| Dentoxol | Experimental | Dentoxol® is a proprietary mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. Subjects will use Dentoxol® mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy. Receives: Device: Dentoxol |
| Placebo | Placebo comparator | The placebo rinse will be identical in color, taste and consistency as the Dentoxol rinse and will be packaged in identical bottles with the same labels. Subjects will use placebo mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale
Measured: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Secondary outcomes (5)
Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale.
Measured: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Mouth pain scores, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
Measured: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Ability to eat, drink, and swallow, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
Measured: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Weight loss, as measured by the difference between weight on first and last day of radiation therapy.
Measured: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Use of opioid analgesics for oral mucositis pain, as expressed in morphine equivalents.
Measured: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startNov 2014
- Primary completionApr 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingalfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastián Sole, Principal investigator, Clinica IRAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885376
- Sponsor's protocol ID
- ING-001
- Status last verified
- Dec 2018
- First submitted
- 26 Aug 2016
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02885376
- Acronym / sponsor ID
- ING-001
- Conditions
- Oral Mucositis
- Keywords
- Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ingalfarma SpAIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- 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.
The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.
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 |
|---|---|---|
| Dentoxol | Experimental | Device: DentoxolDentoxol® is a proprietary mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. Subjects will use Dentoxol® mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy. |
| Placebo | Placebo comparator | Device: PlaceboThe placebo rinse will be identical in color, taste and consistency as the Dentoxol rinse and will be packaged in identical bottles with the same labels. Subjects will use placebo mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned to receive radiation therapy for cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx, with or without concomitant chemotherapy.
- Planned to receive at least 5000cGy radiation therapy to at least 2 of 12 pre-specified areas in the oral cavity
Key exclusion criteria (5 listed)
- Unable to give written informed consent
- Known allergy/intolerance to any component of the study rinse or placebo
- Planning to use any contraindicated medications during the study period (pain medications are allowed)
- Age below 18 years
- Pregnant or nursing (If the patient is a woman of childbearing potential, a pregnancy test must be performed within fourteen days before enrollment in the study)
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 |
|---|---|---|
| DentoxolMouthrinse | Device | Dentoxol |
| PlaceboMouthrinse | Device | Placebo |
Primary outcome
Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
5 secondary outcomes
Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale.
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Mouth pain scores, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Ability to eat, drink, and swallow, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Weight loss, as measured by the difference between weight on first and last day of radiation therapy.
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Use of opioid analgesics for oral mucositis pain, as expressed in morphine equivalents.
Time frame: First day of radiation therapy through last day of radiation therapy (5-8 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 21 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Oral Mucositis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
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.
Sebastián Sole principal investigator
Clinica IRAM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dentoxol in people with Oral Mucositis, run by Ingalfarma SpA at 3 sites in Chile.
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 2 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Chile. 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?
Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale (time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)). 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 21 Dec 2018.