Oral MucositisPhase 2NCT06708702
Copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy
A Phase 2 study testing Copaíba mouthwash in people with Oral Mucositis and Oral Mucositis (Ulcerative) Due to Radiation, run by Instituto Nacional de Cancer, Brazil at 2 sites in Brazil.
Trial summary
Oral mucositis is the most significant acute toxicity of oral cavity radiotherapy. The available scientific evidence supports its preventive and therapeutic approach with low-level laser; however, this is unsuitable for tumor regions due to the risk of stimulating cellular metabolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Oral Mucositis (Ulcerative) Due to Radiation, Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
- What is being tested?
- Copaíba mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesBrazil
- Study dates
- 17 Jan 2025to 7 Jan 2026
- 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
- Patients aged 18 years or older;
- Patients enrolled at INCA diagnosed with malignant neoplasms located in the oral cavity or oropharynx with an extension of the lesion to the oral cavity (IDC-10 C01 to C06 or IDC10); with the indication of exclusive RT (using the Intensity Modulated Radiotherapy (IMRT)/ Volumetric Modulated Arcotherapy (VMAT) technique) or combined with surgery and/or CT;
- Patients with expected RT doses between 50 and 70Gy;
- Patients capable of understanding and adhering to the protocol;
- Patients capable of performing the oral hygiene protocol;
- Patients who, after the information and instructions, can provide the free and informed consent form.
Who cannot join
- Patients who are receiving drugs for the treatment and/or prevention of OM;
- Patients undergoing RT with planning that excludes the oral cavity from the irradiation field;
- Patients who report any allergy to CPB-based compounds.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Instituto Nacional de Cancer, Brazil
Rio de Janeiro, Rio de Janeiro, 20231050
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, 20231050
About this study
Official title: Phase II Study to Evaluate the Effectiviness of copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy
Oral mucositis is the most significant acute toxicity of oral cavity radiotherapy. The available scientific evidence supports its preventive and therapeutic approach with low-level laser; however, this is unsuitable for tumor regions due to the risk of stimulating cellular metabolism. In this sense, an alternative treatment becomes necessary. Based on the preliminary results of the phase I study, a double-blind, randomized phase II study is suggested to evaluate the effectiveness of copaiba-based mouthwash in the prevention of oral mucositis in patients undergoing radiotherapy for oral cavity tumors. Patients will be randomized into 2 groups: A (copaíba) and B (placebo) and will use the mouthwash 4x/day. Each group will have 20 patients and be blind to the group in which they are included. They will be evaluated daily by a dental surgeon about oral mucositis, pain in the oral cavity and oropharynx, and dysphagia and will undergo daily laser therapy sessions, until the end of radiotherapy.
Read the detailed description
Oral cavity cancer represents the 8th most common type in Brazil, with an estimated 15,100 new cases for each year of the 2023-2025 period. It depends on the patient\'s clinical condition, tumor location, and staging, involving surgery, chemotherapy (CT), or radiotherapy (RT), alone or in combination. RT involves doses between 50 and 70 Gy and, in addition to the action on the tumor, it produces toxicity in adjacent tissues, compromising the patient\'s quality of life.
Oral mucositis (OM) is the most significant acute toxicity related to RT associated or not with CT for tumors in this location.7,8 Its preventive and therapeutic approach has been proposed in several ways, but for RT of oral cavity tumors, it has There is evidence for the use of low-level laser therapy (LBP) and benzydamine hydrochloride. However, benzydamine hydrochloride is effective for those who received RT doses of up to 50 Gy, and the application of LBP in the tumor region is contraindicated as its effect is due to the activation of receptors of the respiratory chain, causing stimulation of cellular metabolism. Therefore, OM conditions tend to be severe in these locations, especially in patients with oral tumor lesions. In this sense, the need for an auxiliary treatment method becomes evident.
A phase I study with copaiba (CPB) in patients with oral cancer undergoing RT was previously developed by this group. In this case, the use of the mouthwash did not trigger dose-limiting toxicity in any of the treated patients, allowing us to conclude that the maximum tested dose of 15% used 4 times/day is safe for the development of a phase II study. None of the patients reported pain or burning related to the use of mouthwash in the absence of OM lesions, suggesting that it is safe and non-toxic for this use. The preliminary assessment of the effectiveness of the mouthwash showed the occurrence of OM lesions in 89.5% of patients, at most grade 3; None of the patients evaluated developed grade 4 mucositis lesions according to the WHO scale. None of the patients evaluated in the study needed to interrupt RT or QT due to OM injuries.
OBJECTIVES Main objective: to evaluate the effectiveness of copaiba-based mouthwash in preventing and treating oral mucositis in patients with oral cancer undergoing radiotherapy.
Secondary objectives: evaluate the safety of copaiba mouthwash in patients who use it; compare the incidence of oral mucositis in tumor and non-tumor areas in the two groups; compare the oral cavity pain index in the two groups; compare the oropharyngeal pain index in the two groups; compare the dysphagia index in the two groups.
- Conditions
- Oral Mucositis, Oral Mucositis (Ulcerative) Due to Radiation, Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Oral Mucositis Due to Radiation
- Being tested
- Copaíba mouthwash, Placebo mouthwash
- Keywords
- oral mucositis, radiotheraphy, copaiba, low power laser theraphy
- Medical subject headings
- Stomatitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copaíba mouthwashDrug
A 15% aqueous solution of copaíba (Copaifera Officinalis Resin) manufactured by Interativo Farmácia de Manipulação will be used, under the formula of copaíba oil (Copaifera Officinalis Resin) 15%, liquid mint aroma 5%, tween 80 1%, aqueous solution (Distilled water + Nipagin 0.1%) qsp 100%.
Patients will receive the solution once a week. They will be instructed to shake the bottle before use for homogenization, to use 10mL of the solution for each mouthwash (which should be measured in the 10mL measuring cup that comes with each bottle), 4 times a day, rinsing vigorously for 1 minute and discarding all the solution after use.
Placebo mouthwashDrug
Placebo will be used, under the formula of liquid mint flavor 5%, Nipagim 0.1%, and distilled water qsp 60 ml, packed in packaging compatible with that of the product under investigation, maintaining the same physical characteristics to maintain blinding. The product will be stored at room temperature and stored in the INCA pharmacy.
Patients will receive the solution once a week. They will be instructed to shake the bottle before use for homogenization, to use 10mL of the solution for each mouthwash (which should be measured in the 10mL measuring cup that comes with each bottle), 4 times a day, rinsing vigorously for 1 minute and discarding all the solution after use.
| Study group | Role | What they receive |
|---|---|---|
| Copaíba | Experimental | Not described Receives: Drug: Copaíba mouthwash |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral mucositis ulcers in tumoral area
To evaluate the incidence of oral mucositis (ulcers) in the tumor area in patients with oral cancer undergoing radiotherapy using copaiba-based mouthwash
Measured: From date of randomization until the date of first documented ulcer or date of last RT session/ mouthwash use day, whichever came first, assessed up to 7 weeks
Secondary outcomes (10)
Mouthwashs safety
Assess the safety of copaiba mouthwash/placebo
Measured: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral Mucositis (OMS)
Compare the incidence of maximum grade (grade 1, 2, 3, or 4 according to the WHO scale) of oral mucositis between the two groups
Measured: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral Mucositis ulcers (Sonis)
Compare the average ulcerated area in the tumor area between the two groups according to the Sonis scale
Measured: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral Mucositis erithema (Sonis)
Compare the average area with erythema in the tumor area between the two groups according to the Sonis scale
Measured: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral Mucositis (Sonis)
Compare the average sum of the ulcerated area with the area of erythema in the tumor area between the two groups according to the Sonis scale
Measured: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral pain
Compare the oral cavity pain index in the two groups according to the VAS and the CTCAE v5.0
Measured: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oropharingeal pain
Compare the oropharyngeal pain index in the two groups according to the VAS and CTCAE v5.0
Measured: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Dysphagia
Compare the dysphagia index in the two groups according to CTCAE v5.0
Measured: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Siamoletry
Compare unstimulated sialometry values in the two groups at the beginning, middle, and end of treatment
Measured: At first RT day/ mouthwash use day, in the midle of the RT sessions/ mouthwash use and at last RT session/ mouthwash use day, assessed up to 7 weeks
Cytokines
Compare the levels of pro-inflammatory cytokines IL-1 β, IL-6, and TNF- α in the two groups at the beginning, middle, and end of treatment
Measured: At first RT day/ mouthwash use day, in the midle of the RT sessions/ mouthwash use and at last RT session/ mouthwash use day, assessed up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start17 Jan 2025
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Why it stopped: Poor accrual
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
- Model description
- This is a phase II, randomized, placebo-controlled, double-blind study in a single institution, to evaluate the effectiveness of copaiba-based mouthwash in preventing oral mucositis in the tumor area in patients with oral cancer undergoing RT alone or in combination with CT. The participant will be randomized 1:1 to the study groups in a stratified manner according to the oncological treatments to which the patient will be subjected, according to the groups: exclusive treatment with RT and treatment with RT associated with CT. Randomization will be carried out using the REDCap® program by a non-blinded pharmacist, trained for this role. Participants\' daily care (outcome assessment) will begin on the first day of RT, and continue until the end of it, regardless of whether the patient has already reached the study\'s primary outcome or not.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heliton Spindola Antunes, Instituto Nacional de Cancer, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708702
- Sponsor's protocol ID
- 76178323.4.0000.5274
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Effectiviness of copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy
- ClinicalTrials.gov ID
- NCT06708702
- Acronym / sponsor ID
- 76178323.4.0000.5274
- Conditions
- Oral Mucositis, Oral Mucositis (Ulcerative) Due to Radiation, Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Oral Mucositis Due to Radiation
- Keywords
- oral mucositis, radiotheraphy, copaiba, low power laser theraphy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 27 Nov 2024 (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.
Oral mucositis is the most significant acute toxicity of oral cavity radiotherapy. The available scientific evidence supports its preventive and therapeutic approach with low-level laser; however, this is unsuitable for tumor regions due to the risk of stimulating cellular metabolism. In this sense, an alternative treatment becomes necessary. Based on the preliminary results of the phase I study, a double-blind, randomized phase II study is suggested to evaluate the effectiveness of copaiba-based mouthwash in the prevention of oral mucositis in patients undergoing radiotherapy for oral cavity tumors. Patients will be randomized into 2 groups: A (copaíba) and B (placebo) and will use the mouthwash 4x/day. Each group will have 20 patients and be blind to the group in which they are included. They will be evaluated daily by a dental surgeon about oral mucositis, pain in the oral cavity and oropharynx, and dysphagia and will undergo daily laser therapy sessions, until the end of radiotherapy.
Detailed description
Oral cavity cancer represents the 8th most common type in Brazil, with an estimated 15,100 new cases for each year of the 2023-2025 period. It depends on the patient\'s clinical condition, tumor location, and staging, involving surgery, chemotherapy (CT), or radiotherapy (RT), alone or in combination. RT involves doses between 50 and 70 Gy and, in addition to the action on the tumor, it produces toxicity in adjacent tissues, compromising the patient\'s quality of life.
Oral mucositis (OM) is the most significant acute toxicity related to RT associated or not with CT for tumors in this location.7,8 Its preventive and therapeutic approach has been proposed in several ways, but for RT of oral cavity tumors, it has There is evidence for the use of low-level laser therapy (LBP) and benzydamine hydrochloride. However, benzydamine hydrochloride is effective for those who received RT doses of up to 50 Gy, and the application of LBP in the tumor region is contraindicated as its effect is due to the activation of receptors of the respiratory chain, causing stimulation of cellular metabolism. Therefore, OM conditions tend to be severe in these locations, especially in patients with oral tumor lesions. In this sense, the need for an auxiliary treatment method becomes evident.
A phase I study with copaiba (CPB) in patients with oral cancer undergoing RT was previously developed by this group. In this case, the use of the mouthwash did not trigger dose-limiting toxicity in any of the treated patients, allowing us to conclude that the maximum tested dose of 15% used 4 times/day is safe for the development of a phase II study. None of the patients reported pain or burning related to the use of mouthwash in the absence of OM lesions, suggesting that it is safe and non-toxic for this use. The preliminary assessment of the effectiveness of the mouthwash showed the occurrence of OM lesions in 89.5% of patients, at most grade 3; None of the patients evaluated developed grade 4 mucositis lesions according to the WHO scale. None of the patients evaluated in the study needed to interrupt RT or QT due to OM injuries.
OBJECTIVES Main objective: to evaluate the effectiveness of copaiba-based mouthwash in preventing and treating oral mucositis in patients with oral cancer undergoing radiotherapy.
Secondary objectives: evaluate the safety of copaiba mouthwash in patients who use it; compare the incidence of oral mucositis in tumor and non-tumor areas in the two groups; compare the oral cavity pain index in the two groups; compare the oropharyngeal pain index in the two groups; compare the dysphagia index in the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a phase II, randomized, placebo-controlled, double-blind study in a single institution, to evaluate the effectiveness of copaiba-based mouthwash in preventing oral mucositis in the tumor area in patients with oral cancer undergoing RT alone or in combination with CT. The participant will be randomized 1:1 to the study groups in a stratified manner according to the oncological treatments to which the patient will be subjected, according to the groups: exclusive treatment with RT and treatment with RT associated with CT. Randomization will be carried out using the REDCap® program by a non-blinded pharmacist, trained for this role. Participants\' daily care (outcome assessment) will begin on the first day of RT, and continue until the end of it, regardless of whether the patient has already reached the study\'s primary outcome or not.
| Arm | Type | Receives |
|---|---|---|
| Copaíba | Experimental | Drug: Copaíba mouthwash |
| Placebo | Placebo comparator | Drug: Placebo mouthwash |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 years or older;
- Patients enrolled at INCA diagnosed with malignant neoplasms located in the oral cavity or oropharynx with an extension of the lesion to the oral cavity (IDC-10 C01 to C06 or IDC10); with the indication of exclusive RT (using the Intensity Modulated Radiotherapy (IMRT)/ Volumetric Modulated Arcotherapy (VMAT) technique) or combined with surgery and/or CT;
- Patients with expected RT doses between 50 and 70Gy;
- Patients capable of understanding and adhering to the protocol;
- Patients capable of performing the oral hygiene protocol;
Key exclusion criteria (3 listed)
- Patients who are receiving drugs for the treatment and/or prevention of OM;
- Patients undergoing RT with planning that excludes the oral cavity from the irradiation field;
- Patients who report any allergy to CPB-based compounds.
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 |
|---|---|---|
| Copaíba mouthwashA 15% aqueous solution of copaíba (Copaifera Officinalis Resin) manufactured by Interativo Farmácia de Manipulação will be used, under the formula of copaíba oil (Copaifera Officinalis Resin) 15%, liquid mint aroma 5%, tween 80 1%, aqueous solution (Distilled water + Nipagin 0.1%) qsp 100%. Patients will receive the solution once a week. They will be instructed to shake the bottle before use for homogenization, to use 10mL of the solution for each mouthwash (which should be measured in the 10mL measuring cup that comes with each bottle), 4 times a day, rinsing vigorously for 1 minute and discarding all the solution after use. | Drug | Copaíba |
| Placebo mouthwashPlacebo will be used, under the formula of liquid mint flavor 5%, Nipagim 0.1%, and distilled water qsp 60 ml, packed in packaging compatible with that of the product under investigation, maintaining the same physical characteristics to maintain blinding. The product will be stored at room temperature and stored in the INCA pharmacy. Patients will receive the solution once a week. They will be instructed to shake the bottle before use for homogenization, to use 10mL of the solution for each mouthwash (which should be measured in the 10mL measuring cup that comes with each bottle), 4 times a day, rinsing vigorously for 1 minute and discarding all the solution after use. | Drug | Placebo |
Primary outcome
Oral mucositis ulcers in tumoral area
Time frame: From date of randomization until the date of first documented ulcer or date of last RT session/ mouthwash use day, whichever came first, assessed up to 7 weeks
To evaluate the incidence of oral mucositis (ulcers) in the tumor area in patients with oral cancer undergoing radiotherapy using copaiba-based mouthwash
10 secondary outcomes
Mouthwashs safety
Time frame: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral Mucositis (OMS)
Time frame: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral Mucositis ulcers (Sonis)
Time frame: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral Mucositis erithema (Sonis)
Time frame: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral Mucositis (Sonis)
Time frame: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oral pain
Time frame: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Oropharingeal pain
Time frame: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Dysphagia
Time frame: From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks
Siamoletry
Time frame: At first RT day/ mouthwash use day, in the midle of the RT sessions/ mouthwash use and at last RT session/ mouthwash use day, assessed up to 7 weeks
Cytokines
Time frame: At first RT day/ mouthwash use day, in the midle of the RT sessions/ mouthwash use and at last RT session/ mouthwash use day, assessed up to 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Copaíba mouthwash in people with Oral Mucositis and Oral Mucositis (Ulcerative) Due to Radiation, run by Instituto Nacional de Cancer, Brazil at 2 sites in Brazil.
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 3 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: withdrawn, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Oral mucositis ulcers in tumoral area (time frame: From date of randomization until the date of first documented ulcer or date of last RT session/ mouthwash use day, whichever came first, assessed up to 7 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 9 Oct 2026.