Stomatitis (Oral Mucositis)Early Phase 1NCT05034068
Low Level Laser Therapy Versus Benzydamin in Prevention and Treatment of Oral Mucositis
A Early Phase 1 study testing 0.15% bezaydamine hydrochloride. and low power laser with a wavelength of 870 nm in people with Stomatitis (Oral Mucositis), run by Al-Azhar University at 1 site in Egypt.
Trial summary
A prospective study will be conducted at the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology Faculty of Dental Medicine, Assiut branch Al-Azhar University. Patients with head and neck cancer under RT, CT treatment participated in this study were selected from South Egypt Cancer Institute. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomatitis (Oral Mucositis)
- What is being tested?
- 0.15% bezaydamine hydrochloride. and low power laser with a wavelength of 870 nm
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2021to 1 Feb 2022
- Phase
- Early Phase 1
- 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 with head and neck carcinoma were scheduled to receive a RT treatment (two dimensional techniques), covering a wide area of the head and neck region, The RT protocol of the hospital for head and neck cancer patients consisted of treatment sessions 5 days a week, 2Gy per fraction, with a total dose of 70 Gy over 7 weeks (35 sessions). A minimum dose of 50 Gy was delivered to the oral cavity of all patients in the study, either exclusively or associated with chemotherapy.
Who cannot join
- Karnofsky performance status (KPS)less than 60% .
- Hypersensitivity to benzydamine or typical NSAIDs.
- Patients were excluded if they had lock jaw, any previous medical condition (s) hampering wound healing (e.g., diabetes mellitus).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dental medicine Al-Azhar University (Assiut branch)
Asyut, Asyut Governorate, 71511
About this study
Official title: Low Level Laser Therapy Versus Benzydamin in Prevention and Treatment of Oral Mucositis Induced by Anticancer Treatments (Clinical and Biochemical Study)
A prospective study will be conducted at the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology Faculty of Dental Medicine, Assiut branch Al-Azhar University. Patients with head and neck cancer under RT, CT treatment participated in this study were selected from South Egypt Cancer Institute. During clinical examination the medical history of the patient will be recorded. Data related to base illness, type and stage of RT treatment, association or not to chemotherapy will be collected during the whole treatment. After clinical examination, the patients will receive a kit containing toothbrush, dentifrice, and subsequent oral hygiene instruction. Then the patients will be classified into 3 groups as follow: Group I (control group): the patients will be treated by using oral care only and evaluation will be done before cancer treatment and weekly till the treatment completed. Group II: the patients will be treated by using 0.15% bezaydamine hydrochloride. All patients were advised to rinse 15 mL of the solution benzydamine for 2 min, four to eight times daily before and during, and for 2 weeks after completion of cancer therapy. Group III: the patients will be treated by using a low-level laser therapy, the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa.
- Conditions
- Stomatitis (Oral Mucositis)
- Being tested
- 0.15% bezaydamine hydrochloride., low power laser with a wavelength of 870 nm
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.15% bezaydamine hydrochloride.Drug
0.15% bezaydamine hydrochloride was applied in oral mucosa in Patients with head and neck cancer under RT, CT treatment.
low power laser with a wavelength of 870 nmDevice
the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa. The power will be 60 mW, energy density of 6 J/cm2. Irradiation time will be 6 seconds per point based on the laser beam spot size of 0.55cm2
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | the patients will be treated by using oral care only and evaluation will be done before cancer treatment and weekly till the treatment completed. In each weekly visit, oral sites will be examined, and a score was given to each site based on the degree of mucositis. |
| bezaydamine hydrochloride. | Active comparator | All patients were advised to rinse 15 mL of the solution benzydamine for 2 min, four to eight times daily before and during, and for 2 weeks after completion of cancer therapy. In case of any problem (e.g. burning or stinging), patients will be allowed to dilute the solution with water in the ratio 1:1 or 1:2. Study evaluations will be conducted before cancer treatment and weekly thereafter until 2 weeks after completion of the therapy .In each weekly visit, oral sites were examined and a score was given to each site based on the degree of mucositis. Receives: Drug: 0.15% bezaydamine hydrochloride. |
| low-level laser therapy | Active comparator | the patients will be treated by using a low-level laser therapy, the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa. The power will be 60 mW, energy density of 6 J/cm2. Irradiation time will be 6 seconds per point based on the laser beam spot size of 0.55cm2. The irradiations will be done intra-orally avoiding the tumor site, oral examinations will be recorded at each irradiation session and the degree of mucositis will be recorded. Receives: Device: low power laser with a wavelength of 870 nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-α [picograms/millimeter (pg/ml)] in saliva
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80C. Enzyme-linked immunosorbent assays were used to quantify TNF-α amount in picograms.
Measured: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
IL-6 [picograms/millimeter (pg/ml)] in saliva
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80C. Enzyme-linked immunosorbent assays were used to quantify IL-6 amount in picograms.
Measured: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
WHO scale for severity of oral mucositis.
WHO scale scoring severity of oral mucositis by assessor as following:
Score 0-no signs or symptoms. Score 1-oral soreness and erythema. Score 2-oral erythema and ulcers, both solid and liquid diets tolerated. Score3-oral ulcers, liquid diet only. Score 4-oral alimentation impossible.
Measured: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
National Institute of the Cancer-Common Toxicity criteria (NIC-CTC) RT-induced oral mucositis scale for extent of oral mucositis.
(NIC-CTC) RT-induced oral mucositis scale scoring extension of mucositid as following: (0) patients with oral mucosa presenting no visible alteration.
- Presence of erythema.
- Ulcers with up to 1.5 cm diameter and noncontiguous.
- Ulcers larger than 1.5 cm diameter and contiguous.
- Ulcers exhibiting necrosis and bleeding.
- Death related to toxicity
Measured: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
visual analog scale (VAS) scale for pain assessment
The VAS was modified according to the scale proposed by Bensadoun et al. : scores 1 and 2 (mild pain) were considered grade I, scores 3 and 4 (moderate pain) were grade II, scores of 5 to 7 (severe pain) were grade III and scores of 8 to 10 (very severe pain) were grade IV.
Measured: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start5 Oct 2021
- Primary completion30 Jan 2022
- Study completion1 Feb 2022
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 Stomatitis (Oral Mucositis)Studies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asem Mohammed Kamel Ali, Al-Azhar University
- Investigators
- Ashraf I Gaafar, professor, Study director, Faculty of dental medicine Al-Azhar university Assiut BranchAzza sh Mahmoud, phD, Principal investigator, South Egypt Cancer Institute, Assiut University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034068
- Sponsor's protocol ID
- Treatment of Oral Mucositis
- Status last verified
- Mar 2022
- First submitted
- 26 Aug 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
PubMed 15108222Peterson DE. New strategies for management of oral mucositis in cancer patients. J Support Oncol. 2006 Feb;4(2 Suppl 1):9-13.
PubMed 16499139Guimaraes DM, Ota TMN, Da Silva DAC, Almeida FLDS, Schalch TD, Deana AM, Junior JMA, Fernandes KPS. Low-level laser or LED photobiomodulation on oral mucositis in pediatric patients under high doses of methotrexate: prospective, randomized, controlled trial. Support Care Cancer. 2021 Nov;29(11):6441-6447. doi: 10.1007/s00520-021-06206-9. Epub 2021 Apr 24.
PubMed 33893842
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Therapy Versus Benzydamin in Prevention and Treatment of Oral Mucositis Induced by Anticancer Treatments (Clinical and Biochemical Study)
- ClinicalTrials.gov ID
- NCT05034068
- Acronym / sponsor ID
- Treatment of Oral Mucositis
- Conditions
- Stomatitis (Oral Mucositis)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 5 Sep 2021 (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.
A prospective study will be conducted at the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology Faculty of Dental Medicine, Assiut branch Al-Azhar University. Patients with head and neck cancer under RT, CT treatment participated in this study were selected from South Egypt Cancer Institute. During clinical examination the medical history of the patient will be recorded. Data related to base illness, type and stage of RT treatment, association or not to chemotherapy will be collected during the whole treatment. After clinical examination, the patients will receive a kit containing toothbrush, dentifrice, and subsequent oral hygiene instruction. Then the patients will be classified into 3 groups as follow: Group I (control group): the patients will be treated by using oral care only and evaluation will be done before cancer treatment and weekly till the treatment completed. Group II: the patients will be treated by using 0.15% bezaydamine hydrochloride. All patients were advised to rinse 15 mL of the solution benzydamine for 2 min, four to eight times daily before and during, and for 2 weeks after completion of cancer therapy. Group III: the patients will be treated by using a low-level laser therapy, the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –the patients will be treated by using oral care only and evaluation will be done before cancer treatment and weekly till the treatment completed. In each weekly visit, oral sites will be examined, and a score was given to each site based on the degree of mucositis. |
| bezaydamine hydrochloride. | Active comparator | Drug: 0.15% bezaydamine hydrochloride.All patients were advised to rinse 15 mL of the solution benzydamine for 2 min, four to eight times daily before and during, and for 2 weeks after completion of cancer therapy. In case of any problem (e.g. burning or stinging), patients will be allowed to dilute the solution with water in the ratio 1:1 or 1:2. Study evaluations will be conducted before cancer treatment and weekly thereafter until 2 weeks after completion of the therapy .In each weekly visit, oral sites were examined and a score was given to each site based on the degree of mucositis. |
| low-level laser therapy | Active comparator | Device: low power laser with a wavelength of 870 nmthe patients will be treated by using a low-level laser therapy, the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa. The power will be 60 mW, energy density of 6 J/cm2. Irradiation time will be 6 seconds per point based on the laser beam spot size of 0.55cm2. The irradiations will be done intra-orally avoiding the tumor site, oral examinations will be recorded at each irradiation session and the degree of mucositis will be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -patients with head and neck carcinoma were scheduled to receive a RT treatment (two dimensional techniques), covering a wide area of the head and neck region, The RT protocol of the hospital for head and neck cancer patients consisted of treatment sessions 5 days a week, 2Gy per fraction, with a total dose of 70 Gy over 7 weeks (35 sessions). A minimum dose of 50 Gy was delivered to the oral cavity of all patients in the study, either exclusively or associated with chemotherapy.
Key exclusion criteria (3 listed)
- Karnofsky performance status (KPS)less than 60% .
- Hypersensitivity to benzydamine or typical NSAIDs.
- Patients were excluded if they had lock jaw, any previous medical condition (s) hampering wound healing (e.g., diabetes mellitus).
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 |
|---|---|---|
| 0.15% bezaydamine hydrochloride.0.15% bezaydamine hydrochloride was applied in oral mucosa in Patients with head and neck cancer under RT, CT treatment. | Drug | bezaydamine hydrochloride. |
| low power laser with a wavelength of 870 nmthe irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa. The power will be 60 mW, energy density of 6 J/cm2. Irradiation time will be 6 seconds per point based on the laser beam spot size of 0.55cm2 | Device | low-level laser therapy |
Primary outcome
TNF-α [picograms/millimeter (pg/ml)] in saliva
Time frame: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80C. Enzyme-linked immunosorbent assays were used to quantify TNF-α amount in picograms.
IL-6 [picograms/millimeter (pg/ml)] in saliva
Time frame: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80C. Enzyme-linked immunosorbent assays were used to quantify IL-6 amount in picograms.
WHO scale for severity of oral mucositis.
Time frame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
WHO scale scoring severity of oral mucositis by assessor as following: Score 0-no signs or symptoms. Score 1-oral soreness and erythema. Score 2-oral erythema and ulcers, both solid and liquid diets tolerated. Score3-oral ulcers, liquid diet only. Score 4-oral alimentation impossible.
National Institute of the Cancer-Common Toxicity criteria (NIC-CTC) RT-induced oral mucositis scale for extent of oral mucositis.
Time frame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
(NIC-CTC) RT-induced oral mucositis scale scoring extension of mucositid as following: (0) patients with oral mucosa presenting no visible alteration. 1. Presence of erythema. 2. Ulcers with up to 1.5 cm diameter and noncontiguous. 3. Ulcers larger than 1.5 cm diameter and contiguous. 4. Ulcers exhibiting necrosis and bleeding. 5. Death related to toxicity
visual analog scale (VAS) scale for pain assessment
Time frame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
The VAS was modified according to the scale proposed by Bensadoun et al. : scores 1 and 2 (mild pain) were considered grade I, scores 3 and 4 (moderate pain) were grade II, scores of 5 to 7 (severe pain) were grade III and scores of 8 to 10 (very severe pain) were grade IV.
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 22 Mar 2022.
- Background: PubMed 15108222Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
- Background: PubMed 16499139Peterson DE. New strategies for management of oral mucositis in cancer patients. J Support Oncol. 2006 Feb;4(2 Suppl 1):9-13.
- Background: PubMed 33893842Guimaraes DM, Ota TMN, Da Silva DAC, Almeida FLDS, Schalch TD, Deana AM, Junior JMA, Fernandes KPS. Low-level laser or LED photobiomodulation on oral mucositis in pediatric patients under high doses of methotrexate: prospective, randomized, controlled trial. Support Care Cancer. 2021 Nov;29(11):6441-6447. doi: 10.1007/s00520-021-06206-9. Epub 2021 Apr 24.
- Individual participant dataSharing planned: No
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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.
Ashraf I Gaafar, professor study director
Faculty of dental medicine Al-Azhar university Assiut Branch
Azza sh Mahmoud, phD principal investigator
South Egypt Cancer Institute, Assiut University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 0.15% bezaydamine hydrochloride. and low power laser with a wavelength of 870 nm in people with Stomatitis (Oral Mucositis), run by Al-Azhar University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 22 Mar 2022. 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 Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
TNF-α [picograms/millimeter (pg/ml)] in saliva (time frame: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)). The study lists 5 primary outcomes in all. 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 NCT05034068, 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 22 Mar 2022.