OZOCLO_MUCOSITIS: a New Protocol for Prevention of Oral Mucositis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-01-10

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Mucositis (MeSH Unique ID: D052016) Stomatitis (MeSH Unique ID: D013280)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Nobody else

Study Groups

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Group I, OZOCLO

• 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 Type EXPERIMENTAL

1. alpha acid lipoic - tables

Intervention Type DRUG

600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days

2. ozonated oil - mouthwash

Intervention Type DRUG

1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 2 weeks

3. chlorhexidine 0,2% - mouthwash

Intervention Type DRUG

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

• 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 Type PLACEBO_COMPARATOR

4. sodium bicarbonate 5% solution - mouthwash

Intervention Type DRUG

1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 3 weeks

Group III, CHX

• 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 Type ACTIVE_COMPARATOR

3. chlorhexidine 0,2% - mouthwash

Intervention Type DRUG

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

• 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

Group Type ACTIVE_COMPARATOR

1. alpha acid lipoic - tables

Intervention Type DRUG

600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days

2. ozonated oil - mouthwash

Intervention Type DRUG

1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 2 weeks

Interventions

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1. alpha acid lipoic - tables

600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days

Intervention Type DRUG

2. ozonated oil - mouthwash

1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 2 weeks

Intervention Type DRUG

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

Intervention Type DRUG

4. sodium bicarbonate 5% solution - mouthwash

1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 3 weeks

Intervention Type DRUG

Other Intervention Names

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alpha acid lipoic - tables ozonated oil - mouthwash chlorhexidine 0,2% - mouthwash sodium bicarbonate 5% solution - mouthwash

Eligibility Criteria

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Inclusion Criteria

* 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)
* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No