Mucositis (MeSH Unique ID: D052016)Phase 4OZOCLO_MUCOSNCT05211622
OZOCLO_MUCOSITIS: a New Protocol for Prevention of Oral Mucositis
A Phase 4 study testing 1. alpha acid lipoic - tables, 2. ozonated oil - mouthwash and 3. chlorhexidine 0,2% - mouthwash in people with Mucositis (MeSH Unique ID: D052016) and Stomatitis (MeSH Unique ID: D013280), run by University of Palermo.
Trial summary
Oral mucositis (OM) is a significant side effect of cytotoxic anti-cancer chemotherapy and HN radiotherapy. CT-associated OM (CT-OM). It is the ulcerative phase that is most painful and associated with poor health outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mucositis (MeSH Unique ID: D052016), Stomatitis (MeSH Unique ID: D013280)
- What is being tested?
- 1. alpha acid lipoic - tables, 2. ozonated oil - mouthwash and 3. chlorhexidine 0,2% - mouthwash
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2022to 10 Jan 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years
- Planned to receive conventional chemotherapy such as:
- CMF (cyclophosphamide (Endoxan), methotrexate, 5-FU))
- Standard AC+T regimen (doxorubicin (Adriamycin)), cyclophosphamide (Endoxan), Taxane [paclitaxel (Taxol) or docetaxel (Taxotere)) or any combination of two or more components (e.g., ACT, TAC, TA, AT, AC)
- ABVD (doxorubicin (Adriamycin), bleomycin, vinblastine, dacarbazine)
- FOLFIRI (irinotecan, 5-FU, leucovorin)
Show all 10Show fewer
- Any other 5-FU-based regimen
- Planned to receive at conventional new generation targeted agents (tyrosine-kinase inhibitors or monoclonal antibodies) such as cetuximab, axitinib, bevacizumab, sunitinib, and sorafenib, temsirolimus, everolimus, vemurafenib, dabrafenib.
- Be willing and able to complete all study-related activities
- Properly obtained written informed consent
Who cannot join
- Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
- Concurrent radiotherapy
- Unable or unwilling to complete study assessments
- Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days before randomization
- Any other clinical or psychiatric condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the protocol
- Chronic use of opioid analgesics
Trial locations and contacts
No sites are listed yet.
About this study
Official title: OZOCLO: a Randomized Clinical Trial for Prevention of Oral Mucositis
Oral mucositis (OM) is a significant side effect of cytotoxic anti-cancer chemotherapy and HN radiotherapy. CT-associated OM (CT-OM). It is the ulcerative phase that is most painful and associated with poor health outcomes. The sequelae of CT-OM, which include pain, odyno/dys-phagia, dysgeusia, decreased oral intake and systemic infection, frequently require treatment delays, interruptions, and discontinuations that not only negatively impact the quality of life but also tumor control and survivorship. To date, OM management is aimed to control symptoms through topical or systemic analgesics and topical application of barrier agents to cover injured mucosa as a salve or ointment. According to the recent MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy, no guideline was possible regarding the use of saline or sodium bicarbonate rinses in the prevention or treatment of OM-CT in patients undergoing cancer therapy because of limited data.
Ozone at low medical concentration, not included in MASCC guidelines, will be generally proven to induce a mild activation of protective anti-oxidant pathways, thus exerting therapeutic effects in many inflammatory diseases.
Aim: to evaluate the effectiveness of a new protocol OZOCLO (alpha-lipoic acid, ozonated oil, and chlorhexidine [CHX] mouthwash) compared to sodium bicarbonate solution (Oral Basic Care- OBC) or chlorhexidine (CHX) mouthwash alone or to a binomial administration (AAL-OZ) of systemic alpha-lipoic acid and topical ozonated oil to reduce the incidence of OM (primary aim) and/or to postpone the beginning of oral mucositis (OM) and to reduce OM severity (secondary aims).
Read the detailed description
Oral mucositis (OM) is a significant side effect of cytotoxic anti-cancer chemotherapy and HN radiotherapy. CT-associated OM (CT-OM) begins in the submucosa and becomes clinically on the surface about 4 days after infusion: typical primary manifestations are erythema, mucosal atrophy, and sensitivity. The process continues to deteriorate mucosae, and ulceration occurs a few days later, peaking at 2 weeks and persisting for 1-2 weeks after which it typically resolves spontaneously. It is the ulcerative phase that is most painful and associated with poor health outcomes. The sequelae of CT-OM, which include pain, odyno/dys-phagia, dysgeusia, decreased oral intake and systemic infection, frequently require treatment delays, interruptions, and discontinuations that not only negatively impact the quality of life but also tumor control and survivorship. To date, OM management is aimed to control symptoms through topical or systemic analgesics and topical application of barrier agents to cover injured mucosa as a salve or ointment. Although the investigators reviewed a large body of evidence, there are still, clinical settings for which there is no recommended intervention. According to the recent MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy, no guideline was possible regarding the use of saline or sodium bicarbonate rinses in the prevention or treatment of OM-CT in patients undergoing cancer therapy because of limited data. Despite the limited data available for both saline and sodium bicarbonate, the panel recognizes that these are inert, bland rinses that increase oral clearance, which may help maintain oral hygiene and improve patient comfort. Also, CHX is indicated because of concurrent oral infection and OM, it is acceptable to use it for the oral infection.
Ozone at low medical concentration, not included in MASCC guidelines, will be generally proven to induce a mild activation of protective anti-oxidant pathways, thus exerting therapeutic effects in many inflammatory diseases.
Aim: to evaluate the effectiveness of a new protocol OZOCLO (alpha-lipoic acid, ozonated oil, and chlorhexidine [CHX] mouthwash) compared to sodium bicarbonate solution (Oral Basic Care- OBC) or chlorhexidine (CHX) mouthwash alone or to a binomial administration (AAL-OZ) of systemic alpha-lipoic acid and topical ozonated oil to reduce the incidence of OM (primary aim) and/or to postpone the beginning of oral mucositis (OM) and to reduce OM severity (secondary aims).
- Being tested
- 1. alpha acid lipoic - tables, 2. ozonated oil - mouthwash, 3. chlorhexidine 0,2% - mouthwash, 4. sodium bicarbonate 5% solution - mouthwash
- Medical subject headings
- Mucositis, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. alpha acid lipoic - tablesDrug
Also called alpha acid lipoic - tables
600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days
2. ozonated oil - mouthwashDrug
Also called ozonated oil - mouthwash
1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 2 weeks
3. chlorhexidine 0,2% - mouthwashDrug
Also called chlorhexidine 0,2% - mouthwash
1 minute- three times/die after oral hygiene, possibly, from five days after the beginning of chemotherapy and for subsequent 2 weeks
4. sodium bicarbonate 5% solution - mouthwashDrug
Also called sodium bicarbonate 5% solution - mouthwash
1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group I, OZOCLO | Experimental | • Group I, OZOCLO
1. alpha acid lipoic - 600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days
2. ozonated oil - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 2 weeks
3. chlorhexidine 0,2% - mouthwash (1 minute- three times/die after oral hygiene, possibly) from five days after the beginning of chemotherapy and for subsequent 2 weeks Receives: Drug: 1. alpha acid lipoic - tables; Drug: 2. ozonated oil - mouthwash; Drug: 3. chlorhexidine 0,2% - mouthwash |
| Group II, OBC | Placebo comparator | • Group II, OBC Sodium bicarbonate 5% solution - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 3 weeks Receives: Drug: 4. sodium bicarbonate 5% solution - mouthwash |
| Group III, CHX | Active comparator | • Group III, CHX Chlorhexidine 0,2% - mouthwash (1 minute- three times/die after oral hygiene, possibly) from five days after the beginning of chemotherapy and for subsequent 2 weeks Receives: Drug: 3. chlorhexidine 0,2% - mouthwash |
| Group IV, AAL-OZ | Active comparator | • Group IV, AAL-OZ
1. alpha acid lipoic - 600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days
2. ozonated oil - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 2 weeks Receives: Drug: 1. alpha acid lipoic - tables; Drug: 2. ozonated oil - mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of OM incidence
In order to demonstrate whether the new protocol OZOCLO determines change of the incidence of OM compared to sodium bicarbonate solution (OBC) or chlorhexidine (CHX) mouthwash alone or the binomial AAL-OZ combination, in patients treated with chemotherapy regimens.
Measured: 7th, 14th, and the 21st day after application of the interventions
Secondary outcomes (1)
Delay onset of OM
In order to determine whether the new protocol OZOCLO determines a delay of onset for OM, considering that it currently begins at 7th day, compared to sodium bicarbonate solution (OBC) or chlorhexidine (CHX) mouthwash alone or a binomial administration of systemic alpha-lipoic acid and topical ozonated oil.
Measured: 7th, 14th, and the 21st day after application of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start10 Mar 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mucositis (MeSH Unique ID: D052016)Studies 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
- Factorial
- Model description
- Patients will be randomly using a table of random numbers (allocation ratio 1:1:1:1). * Arm I, OZOCLO 1. alpha acid lipoic - 600 mg/die per os from 7 days before the beginning of chemotherapy and for other 4 die 2. ozonated oil - mouthwash (1 minute- three times/die) for 2 weeks 3. chlorhexidine 0,2% - mouthwash (1 minute- three times/die) from five days after the beginning and for other 2 weeks * Arm II, OBC Sodium bicarbonate 5% solution - mouthwash (1 minute- three times/die) for 3 weeks * Arm III, CHX Chlorhexidine 0,2% - mouthwash (1 minute- three times/die) from five days after the beginning and for other 2 weeks * Arm IV, AAL-OZ 1. alpha acid lipoic - 600 mg/die per os from 7 days before the beginning and continue for other 4 die 2. ozonated oil - mouthwash (1 minute- three times/die) from the beginning and for 2 weeks Every interventional arm will be conducted by the patient at home according to indications and will monitored at 8th, 15th, and the 21st day
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Di Fede, University of Palermo
- Investigators
- Olga Di Fede, Professor, Principal investigator, University of Palermo, Di.Chir.On.S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211622
- Sponsor's protocol ID
- OZOCLO_MUCOSITIS 01_2021
- Acronym
- OZOCLO_MUCOS
- Status last verified
- Dec 2021
- First submitted
- 14 Dec 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
PubMed 32786044Cardona A, Balouch A, Abdul MM, Sedghizadeh PP, Enciso R. Efficacy of chlorhexidine for the prevention and treatment of oral mucositis in cancer patients: a systematic review with meta-analyses. J Oral Pathol Med. 2017 Oct;46(9):680-688. doi: 10.1111/jop.12549. Epub 2017 Feb 8.
PubMed 28075506Ferretti GA, Raybould TP, Brown AT, Macdonald JS, Greenwood M, Maruyama Y, Geil J, Lillich TT, Ash RC. Chlorhexidine prophylaxis for chemotherapy- and radiotherapy-induced stomatitis: a randomized double-blind trial. Oral Surg Oral Med Oral Pathol. 1990 Mar;69(3):331-8. doi: 10.1016/0030-4220(90)90295-4.
PubMed 2179802
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OZOCLO: a Randomized Clinical Trial for Prevention of Oral Mucositis
- ClinicalTrials.gov ID
- NCT05211622
- Acronym / sponsor ID
- OZOCLO_MUCOS / OZOCLO_MUCOSITIS 01_2021
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 10 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 27 Jan 2022 (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 (OM) is a significant side effect of cytotoxic anti-cancer chemotherapy and HN radiotherapy. CT-associated OM (CT-OM). It is the ulcerative phase that is most painful and associated with poor health outcomes. The sequelae of CT-OM, which include pain, odyno/dys-phagia, dysgeusia, decreased oral intake and systemic infection, frequently require treatment delays, interruptions, and discontinuations that not only negatively impact the quality of life but also tumor control and survivorship. To date, OM management is aimed to control symptoms through topical or systemic analgesics and topical application of barrier agents to cover injured mucosa as a salve or ointment. According to the recent MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy, no guideline was possible regarding the use of saline or sodium bicarbonate rinses in the prevention or treatment of OM-CT in patients undergoing cancer therapy because of limited data.
Ozone at low medical concentration, not included in MASCC guidelines, will be generally proven to induce a mild activation of protective anti-oxidant pathways, thus exerting therapeutic effects in many inflammatory diseases.
Aim: to evaluate the effectiveness of a new protocol OZOCLO (alpha-lipoic acid, ozonated oil, and chlorhexidine [CHX] mouthwash) compared to sodium bicarbonate solution (Oral Basic Care- OBC) or chlorhexidine (CHX) mouthwash alone or to a binomial administration (AAL-OZ) of systemic alpha-lipoic acid and topical ozonated oil to reduce the incidence of OM (primary aim) and/or to postpone the beginning of oral mucositis (OM) and to reduce OM severity (secondary aims).
Detailed description
Oral mucositis (OM) is a significant side effect of cytotoxic anti-cancer chemotherapy and HN radiotherapy. CT-associated OM (CT-OM) begins in the submucosa and becomes clinically on the surface about 4 days after infusion: typical primary manifestations are erythema, mucosal atrophy, and sensitivity. The process continues to deteriorate mucosae, and ulceration occurs a few days later, peaking at 2 weeks and persisting for 1-2 weeks after which it typically resolves spontaneously. It is the ulcerative phase that is most painful and associated with poor health outcomes. The sequelae of CT-OM, which include pain, odyno/dys-phagia, dysgeusia, decreased oral intake and systemic infection, frequently require treatment delays, interruptions, and discontinuations that not only negatively impact the quality of life but also tumor control and survivorship. To date, OM management is aimed to control symptoms through topical or systemic analgesics and topical application of barrier agents to cover injured mucosa as a salve or ointment. Although the investigators reviewed a large body of evidence, there are still, clinical settings for which there is no recommended intervention. According to the recent MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy, no guideline was possible regarding the use of saline or sodium bicarbonate rinses in the prevention or treatment of OM-CT in patients undergoing cancer therapy because of limited data. Despite the limited data available for both saline and sodium bicarbonate, the panel recognizes that these are inert, bland rinses that increase oral clearance, which may help maintain oral hygiene and improve patient comfort. Also, CHX is indicated because of concurrent oral infection and OM, it is acceptable to use it for the oral infection.
Ozone at low medical concentration, not included in MASCC guidelines, will be generally proven to induce a mild activation of protective anti-oxidant pathways, thus exerting therapeutic effects in many inflammatory diseases.
Aim: to evaluate the effectiveness of a new protocol OZOCLO (alpha-lipoic acid, ozonated oil, and chlorhexidine [CHX] mouthwash) compared to sodium bicarbonate solution (Oral Basic Care- OBC) or chlorhexidine (CHX) mouthwash alone or to a binomial administration (AAL-OZ) of systemic alpha-lipoic acid and topical ozonated oil to reduce the incidence of OM (primary aim) and/or to postpone the beginning of oral mucositis (OM) and to reduce OM severity (secondary aims).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Patients will be randomly using a table of random numbers (allocation ratio 1:1:1:1). * Arm I, OZOCLO 1. alpha acid lipoic - 600 mg/die per os from 7 days before the beginning of chemotherapy and for other 4 die 2. ozonated oil - mouthwash (1 minute- three times/die) for 2 weeks 3. chlorhexidine 0,2% - mouthwash (1 minute- three times/die) from five days after the beginning and for other 2 weeks * Arm II, OBC Sodium bicarbonate 5% solution - mouthwash (1 minute- three times/die) for 3 weeks * Arm III, CHX Chlorhexidine 0,2% - mouthwash (1 minute- three times/die) from five days after the beginning and for other 2 weeks * Arm IV, AAL-OZ 1. alpha acid lipoic - 600 mg/die per os from 7 days before the beginning and continue for other 4 die 2. ozonated oil - mouthwash (1 minute- three times/die) from the beginning and for 2 weeks Every interventional arm will be conducted by the patient at home according to indications and will monitored at 8th, 15th, and the 21st day
| Arm | Type | Receives |
|---|---|---|
| Group I, OZOCLO | Experimental | Drug: 1. alpha acid lipoic - tables, Drug: 2. ozonated oil - mouthwash, Drug: 3. chlorhexidine 0,2% - mouthwash• Group I, OZOCLO 1. alpha acid lipoic - 600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days 2. ozonated oil - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 2 weeks 3. chlorhexidine 0,2% - mouthwash (1 minute- three times/die after oral hygiene, possibly) from five days after the beginning of chemotherapy and for subsequent 2 weeks |
| Group II, OBC | Placebo comparator | Drug: 4. sodium bicarbonate 5% solution - mouthwash• Group II, OBC Sodium bicarbonate 5% solution - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 3 weeks |
| Group III, CHX | Active comparator | Drug: 3. chlorhexidine 0,2% - mouthwash• Group III, CHX Chlorhexidine 0,2% - mouthwash (1 minute- three times/die after oral hygiene, possibly) from five days after the beginning of chemotherapy and for subsequent 2 weeks |
| Group IV, AAL-OZ | Active comparator | Drug: 1. alpha acid lipoic - tables, Drug: 2. ozonated oil - mouthwash• Group IV, AAL-OZ 1. alpha acid lipoic - 600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days 2. ozonated oil - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 2 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-80 years
- Planned to receive conventional chemotherapy such as:
- Planned to receive at conventional new generation targeted agents (tyrosine-kinase inhibitors or monoclonal antibodies) such as cetuximab, axitinib, bevacizumab, sunitinib, and sorafenib, temsirolimus, everolimus, vemurafenib, dabrafenib.
- Be willing and able to complete all study-related activities
- Properly obtained written informed consent
Key exclusion criteria (6 listed)
- Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
- Concurrent radiotherapy
- Unable or unwilling to complete study assessments
- Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days before randomization
- Any other clinical or psychiatric condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the protocol
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 |
|---|---|---|
| 1. alpha acid lipoic - tablesAlso: alpha acid lipoic - tables600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days | Drug | Group I, OZOCLO, Group IV, AAL-OZ |
| 2. ozonated oil - mouthwashAlso: ozonated oil - mouthwash1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 2 weeks | Drug | Group I, OZOCLO, Group IV, AAL-OZ |
| 3. chlorhexidine 0,2% - mouthwashAlso: chlorhexidine 0,2% - mouthwash1 minute- three times/die after oral hygiene, possibly, from five days after the beginning of chemotherapy and for subsequent 2 weeks | Drug | Group I, OZOCLO, Group III, CHX |
| 4. sodium bicarbonate 5% solution - mouthwashAlso: sodium bicarbonate 5% solution - mouthwash1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 3 weeks | Drug | Group II, OBC |
Primary outcome
Change of OM incidence
Time frame: 7th, 14th, and the 21st day after application of the interventions
In order to demonstrate whether the new protocol OZOCLO determines change of the incidence of OM compared to sodium bicarbonate solution (OBC) or chlorhexidine (CHX) mouthwash alone or the binomial AAL-OZ combination, in patients treated with chemotherapy regimens.
1 secondary outcome
Delay onset of OM
Time frame: 7th, 14th, and the 21st day after application of the interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Results publication: PubMed 32786044Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
- Results publication: PubMed 28075506Cardona A, Balouch A, Abdul MM, Sedghizadeh PP, Enciso R. Efficacy of chlorhexidine for the prevention and treatment of oral mucositis in cancer patients: a systematic review with meta-analyses. J Oral Pathol Med. 2017 Oct;46(9):680-688. doi: 10.1111/jop.12549. Epub 2017 Feb 8.
- Results publication: PubMed 2179802Ferretti GA, Raybould TP, Brown AT, Macdonald JS, Greenwood M, Maruyama Y, Geil J, Lillich TT, Ash RC. Chlorhexidine prophylaxis for chemotherapy- and radiotherapy-induced stomatitis: a randomized double-blind trial. Oral Surg Oral Med Oral Pathol. 1990 Mar;69(3):331-8. doi: 10.1016/0030-4220(90)90295-4.
- Individual participant dataSharing planned: Undecided
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.
Olga Di Fede, Professor principal investigator
University of Palermo, Di.Chir.On.S
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1. alpha acid lipoic - tables, 2. ozonated oil - mouthwash and 3. chlorhexidine 0,2% - mouthwash in people with Mucositis (MeSH Unique ID: D052016) and Stomatitis (MeSH Unique ID: D013280), run by University of Palermo.
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 10 inclusion and 6 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 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 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 Olga Di Fede, Professor (+39 3294030298, olga.difede@unipa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of OM incidence (time frame: 7th, 14th, and the 21st day after application of the interventions). 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 NCT05211622, which also lists 3 linked publications.
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 27 Jan 2022.