MucositisPhase 4NCT01707641
Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer
A Phase 4 study testing CD#2 and bicarbonate sodium mouthwash in people with Mucositis, run by S. Andrea Hospital at 1 site in Italy.
Trial summary
Oral mucositis is a debilitating side effect for oncology patients and there is a clear need for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a potential new alternative for the prevention of grade III and IV mucositis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis
- What is being tested?
- CD#2 and bicarbonate sodium mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Dec 2019
- Phase
- Phase 4
- 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
- male and female patients > 18 years of age
- Karnofsky Performance Status >70%
- pathological and histological diagnosis that confirms head and neck tumour
- patients eligible for radical radiotherapy and/or chemotherapy
- expected survival time > 6 months
- normal bone marrow function (neutrophil count >1500/cmm, platelet count > 100.000/CMM)
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- serum creatine < 1.8mg/dl
- total bilirubin <2mg/dl
- GOT, GPT within 3 times the normal limit
- willingness to perform conventional 3D radiotherapy or intensive modulated radiation therapy with concurrent chemotherapy
- signed informed consent form
Who cannot join
- Diagnosis of glottic tumour, parotid or salivary, larynx tumour.
- Presence of metastasis, detected with contrast-enhances TC TB and/or PET/TC
- Major surgery of the oral cavity within the last 4 weeks
- Patients previoucly treated with radiotherapy of head and neck
- Antifungal or antiviral therapy for oral pathological conditions in the last
- Other serious concomitant disease
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- History of insulin-dependent Diabetes Mellituss
- History of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis or Xerostomia
- Patients with body weigh >35 kg
- Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant
- Patients with Hepatitis B / C
- Patients with symptomatic untreated dental infection
- Patients with oral mucositis grade NCICTC 3 or 4
- Histological and pathological diagnosis unavailable
- Patients with signs and symptoms of systemic infection
- Patient's refusal to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Vitaliana De Sanctis, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Sant'Andrea Hospital
Rome, Rome, 00189
Vitaliana De Sanctis, PhD, vitaliana.desanctis@uniroma1.it
Vitaliana De Sanctis, PhD
About this study
Official title: A Randomized Study on the Effects of Lactobacillus Brevis CD2 in the Prevention of Radio and Chemotherapy Induced Oral Mucositis in Head and Neck Cancer Patients.
Oral mucositis is a debilitating side effect for oncology patients and there is a clear need for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a potential new alternative for the prevention of grade III and IV mucositis. The main endpoint of this study is to verify if these lozenges taken 6 times a day may reduce the incidence of grade III and IV mucositis as well as increase the percentage of patients who will complete the radio-chemotherapy treatment.
Read the detailed description
Mucositis is a debilitating side effect of radio and chemotherapy treatment in oncology patients. It is not only painful, but also can limit adequate nutritional intake and decrease the willingness of patients to continue the treatment. Furthermore, extensive mucositis may require additional nutritional supplementation, and narcotic analgesic increasing the cost of the therapy. Quality of life is impaired in patients who develop severe mucositis.
Clinically, it begins with asymptomatic redness and erythema and ultimately passing through different stages to large acutely painful contiguous pseudomembranous lesions with associated dysphagia and decreased oral intake. The common sites of oral mucositis are labial, buccal, soft palate, floor of mouth, and the ventral surface of the tongue. The loss of the epithelial cells exposes the underlying connective tissue with its associated innervations causing pain. Oral infections, which may be due to bacterial, fungal, or viruses may further exacerbate the mucositis as well as lead to systemic infections.
Treatment and prevention of therapy related mucositis is essential; unfortunately, the efficacy and safety of most of the regimen used have not been clearly established. Prophylactic measures employed are use of: chlorhexidine, saline rinses, soda bicarbonate rinses, acyclovir, and ice. For treatment of mucositis and its associated pain local anesthetic, diphenhydramine, nystatin, or sucralfate are used alone or in combination as mouthwash. Oral or parenteral narcotics are also used for pain relief.
There is a clear need for new therapeutic options for oral mucositis.
- Conditions
- Mucositis
- Being tested
- CD#2, bicarbonate sodium mouthwash
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD#2Dietary supplement
Also called Lozenge containing Lactobacillus brevis CD2
patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth
bicarbonate sodium mouthwashOther
Patients will be asked to wash their mouth with bicarbonate sodium several times per day
| Study group | Role | What they receive |
|---|---|---|
| CD#2 | Active comparator | patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2 Receives: Dietary Supplement: CD#2 |
| bicarbonate sodium mouthwash | Active comparator | patients will be asked to wash their mouth with bicarbonate several times per day Receives: Other: bicarbonate sodium mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of grade III/IV mucositis
Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)
Measured: 2 months
Secondary outcomes (1)
percentage of patients able to complete the chemo-radiotherapy treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S. Andrea Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vitaliana De Sanctis, S. Andrea Hospital
- Investigators
- Vitaliana De Sanctis, PhD, Principal investigator, Sant'Andrea Hospital - Radiotherapy Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707641
- Sponsor's protocol ID
- CD2 AIRO
- Status last verified
- May 2014
- First submitted
- 12 Oct 2012
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study on the Effects of Lactobacillus Brevis CD2 in the Prevention of Radio and Chemotherapy Induced Oral Mucositis in Head and Neck Cancer Patients.
- ClinicalTrials.gov ID
- NCT01707641
- Acronym / sponsor ID
- CD2 AIRO
- Conditions
- Mucositis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- S. Andrea HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Oct 2012 (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.
Oral mucositis is a debilitating side effect for oncology patients and there is a clear need for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a potential new alternative for the prevention of grade III and IV mucositis. The main endpoint of this study is to verify if these lozenges taken 6 times a day may reduce the incidence of grade III and IV mucositis as well as increase the percentage of patients who will complete the radio-chemotherapy treatment.
Detailed description
Mucositis is a debilitating side effect of radio and chemotherapy treatment in oncology patients. It is not only painful, but also can limit adequate nutritional intake and decrease the willingness of patients to continue the treatment. Furthermore, extensive mucositis may require additional nutritional supplementation, and narcotic analgesic increasing the cost of the therapy. Quality of life is impaired in patients who develop severe mucositis.
Clinically, it begins with asymptomatic redness and erythema and ultimately passing through different stages to large acutely painful contiguous pseudomembranous lesions with associated dysphagia and decreased oral intake. The common sites of oral mucositis are labial, buccal, soft palate, floor of mouth, and the ventral surface of the tongue. The loss of the epithelial cells exposes the underlying connective tissue with its associated innervations causing pain. Oral infections, which may be due to bacterial, fungal, or viruses may further exacerbate the mucositis as well as lead to systemic infections.
Treatment and prevention of therapy related mucositis is essential; unfortunately, the efficacy and safety of most of the regimen used have not been clearly established. Prophylactic measures employed are use of: chlorhexidine, saline rinses, soda bicarbonate rinses, acyclovir, and ice. For treatment of mucositis and its associated pain local anesthetic, diphenhydramine, nystatin, or sucralfate are used alone or in combination as mouthwash. Oral or parenteral narcotics are also used for pain relief.
There is a clear need for new therapeutic options for oral mucositis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD#2 | Active comparator | Dietary Supplement: CD#2patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2 |
| bicarbonate sodium mouthwash | Active comparator | Other: bicarbonate sodium mouthwashpatients will be asked to wash their mouth with bicarbonate several times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- male and female patients > 18 years of age
- Karnofsky Performance Status >70%
- pathological and histological diagnosis that confirms head and neck tumour
- patients eligible for radical radiotherapy and/or chemotherapy
- expected survival time > 6 months
Key exclusion criteria (16 listed)
- Diagnosis of glottic tumour, parotid or salivary, larynx tumour.
- Presence of metastasis, detected with contrast-enhances TC TB and/or PET/TC
- Major surgery of the oral cavity within the last 4 weeks
- Patients previoucly treated with radiotherapy of head and neck
- Antifungal or antiviral therapy for oral pathological conditions in the last
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 |
|---|---|---|
| CD#2Also: Lozenge containing Lactobacillus brevis CD2patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth | Dietary supplement | CD#2 |
| bicarbonate sodium mouthwashPatients will be asked to wash their mouth with bicarbonate sodium several times per day | Other | bicarbonate sodium mouthwash |
Primary outcome
incidence of grade III/IV mucositis
Time frame: 2 months
Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)
1 secondary outcome
percentage of patients able to complete the chemo-radiotherapy treatment
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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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.
Vitaliana De Sanctis, PhD contact
Vitaliana De Sanctis, PhD principal investigator
Sant'Andrea Hospital - Radiotherapy Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CD#2 and bicarbonate sodium mouthwash in people with Mucositis, run by S. Andrea Hospital at 1 site in Italy.
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 11 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 20 May 2014. 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 Italy. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vitaliana De Sanctis, PhD (vitaliana.desanctis@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of grade III/IV mucositis (time frame: 2 months). 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 20 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.