Chemotherapy Induced Oral MucositisPhase 2NCT06214273
Low Level Diode Laser Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis
A Phase 2 study testing Low level diode laser, Chamomile and Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel in people with Chemotherapy Induced Oral Mucositis, run by Cairo University.
Trial summary
a three-arm head-to-head randomized clinical trial assessing two of the promising studied interventions, low-level diode laser and topical Chamomile, comparing them to each other's and to conventional therapy in the management of oral mucositis-induced chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Oral Mucositis
- What is being tested?
- Low level diode laser, Chamomile and Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Oct 2024
- 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 with chemotherapy-induced oral mucositis.
- Patients who will agree to participate in the study.
- Adult Patients above 18 years.
Who cannot join
- Patients with any visible oral lesions other than oral mucositis.
- Patients who have received radiotherapy 2 weeks earlier to the diagnosis of the oral mucositis
About this study
Official title: Evaluation of Low Level Diode Diode Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis: Three Arm Randomized Clinical Trial
a three-arm head-to-head randomized clinical trial assessing two of the promising studied interventions, low-level diode laser and topical Chamomile, comparing them to each other's and to conventional therapy in the management of oral mucositis-induced chemotherapy.
Read the detailed description
The latest MASCC/ISOO Mucositis Guidelines recommend relieving pain, reducing inflammation, and preventing secondary infection as the main pillars in the management of chemotherapy-induced oral mucositis. Accordingly, our comparator will be conventional therapy, including topical anti-inflammatory, topical analgesic, and topical antifungal.
- Conditions
- Chemotherapy Induced Oral Mucositis
- Being tested
- Low level diode laser, Chamomile, Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level diode laserDevice
Also called Photobiomodulation
diode laser with a wave length range of 800-980 n m and power less than 500 ml
ChamomileDrug
Also called Matricaria
Chamomile 3% mucoadhesive gel
Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gelDrug
Also called conventional oral therapy, Ibuprofen oral gel and miconazole oral gel
Topical anti-inflammatory, topical analgesic and topical antifungal
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen oral gel and miconazole oral gel | Active comparator | One group will receive conventional oral therapy composed of topical ibuprofen oral gel as an anti-inflammatory and analgesic and topical miconazole as an anti-fungal oral gel. Receives: Drug: Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel |
| low-level diode laser diode laser | Experimental | The second group will receive a diode laser with a wave length range of 800-980 nm and power less than 500 ml. Receives: Device: Low level diode laser |
| Chamomile | Experimental | The third group will receive chamomile 3% mucoadhesive gel. Receives: Drug: Chamomile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort and pain
Reported by each patient using the Visual Analog Scale (0-10),10 refers to maximum pain
Measured: On baseline, first, third, fifth, seventh, tenth and 14th day.
Secondary outcomes (2)
Oral mucositis severity
It will be measured using the WHO grading Scale (0-4).4 refers to ulcers, and diet is not possible (due to mucositis).
Measured: On baseline, first, third, fifth, seventh, tenth and 14th day.
The total healing time of oral ulcers
will be recorded for all the patients
Measured: On baseline, first, third, fifth, seventh, tenth and 14th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study startApr 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced Oral MucositisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a three-arm head-to-head RCT assessing two of the promising studied interventions, low-level diode laser and topical chamomile, comparing them to each other's and to conventional therapy.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clair Sobhy Nagieb Botros, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214273
- Sponsor's protocol ID
- 27283522022441
- Status last verified
- Jan 2024
- First submitted
- 13 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs. 1997 Apr;20(2):88-93. doi: 10.1097/00002820-199704000-00002.
PubMed 9145556Soares ADS, Wanzeler AMV, Cavalcante GHS, Barros EMDS, Carneiro RCM, Tuji FM. Therapeutic effects of andiroba (Carapa guianensis Aubl) oil, compared to low power laser, on oral mucositis in children underwent chemotherapy: A clinical study. J Ethnopharmacol. 2021 Jan 10;264:113365. doi: 10.1016/j.jep.2020.113365. Epub 2020 Sep 10.
PubMed 32920135Elhadad MA, El-Negoumy E, Taalab MR, Ibrahim RS, Elsaka RO. The effect of topical chamomile in the prevention of chemotherapy-induced oral mucositis: A randomized clinical trial. Oral Dis. 2022 Jan;28(1):164-172. doi: 10.1111/odi.13749. Epub 2020 Dec 19.
PubMed 33290635de Lima VHS, de Oliveira-Neto OB, da Hora Sales PH, da Silva Torres T, de Lima FJC. Effectiveness of low-level laser therapy for oral mucositis prevention in patients undergoing chemoradiotherapy for the treatment of head and neck cancer: A systematic review and meta-analysis. Oral Oncol. 2020 Mar;102:104524. doi: 10.1016/j.oraloncology.2019.104524. Epub 2020 Feb 13.
PubMed 32062592
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low Level Diode Diode Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis: Three Arm Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06214273
- Acronym / sponsor ID
- 27283522022441
- Conditions
- Chemotherapy Induced Oral Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 19 Jan 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.
a three-arm head-to-head randomized clinical trial assessing two of the promising studied interventions, low-level diode laser and topical Chamomile, comparing them to each other's and to conventional therapy in the management of oral mucositis-induced chemotherapy.
Detailed description
The latest MASCC/ISOO Mucositis Guidelines recommend relieving pain, reducing inflammation, and preventing secondary infection as the main pillars in the management of chemotherapy-induced oral mucositis. Accordingly, our comparator will be conventional therapy, including topical anti-inflammatory, topical analgesic, and topical antifungal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- a three-arm head-to-head RCT assessing two of the promising studied interventions, low-level diode laser and topical chamomile, comparing them to each other's and to conventional therapy.
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen oral gel and miconazole oral gel | Active comparator | Drug: Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gelOne group will receive conventional oral therapy composed of topical ibuprofen oral gel as an anti-inflammatory and analgesic and topical miconazole as an anti-fungal oral gel. |
| low-level diode laser diode laser | Experimental | Device: Low level diode laserThe second group will receive a diode laser with a wave length range of 800-980 nm and power less than 500 ml. |
| Chamomile | Experimental | Drug: ChamomileThe third group will receive chamomile 3% mucoadhesive gel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chemotherapy-induced oral mucositis.
- Patients who will agree to participate in the study.
- Adult Patients above 18 years.
Key exclusion criteria (2 listed)
- Patients with any visible oral lesions other than oral mucositis.
- Patients who have received radiotherapy 2 weeks earlier to the diagnosis of the oral mucositis
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 |
|---|---|---|
| Low level diode laserAlso: Photobiomodulationdiode laser with a wave length range of 800-980 n m and power less than 500 ml | Device | low-level diode laser diode laser |
| ChamomileAlso: MatricariaChamomile 3% mucoadhesive gel | Drug | Chamomile |
| Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gelAlso: conventional oral therapy, Ibuprofen oral gel and miconazole oral gelTopical anti-inflammatory, topical analgesic and topical antifungal | Drug | Ibuprofen oral gel and miconazole oral gel |
Primary outcome
Discomfort and pain
Time frame: On baseline, first, third, fifth, seventh, tenth and 14th day.
Reported by each patient using the Visual Analog Scale (0-10),10 refers to maximum pain
2 secondary outcomes
Oral mucositis severity
Time frame: On baseline, first, third, fifth, seventh, tenth and 14th day.
The total healing time of oral ulcers
Time frame: On baseline, first, third, fifth, seventh, tenth and 14th day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Results publication: PubMed 9145556Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs. 1997 Apr;20(2):88-93. doi: 10.1097/00002820-199704000-00002.
- Results publication: PubMed 32920135Soares ADS, Wanzeler AMV, Cavalcante GHS, Barros EMDS, Carneiro RCM, Tuji FM. Therapeutic effects of andiroba (Carapa guianensis Aubl) oil, compared to low power laser, on oral mucositis in children underwent chemotherapy: A clinical study. J Ethnopharmacol. 2021 Jan 10;264:113365. doi: 10.1016/j.jep.2020.113365. Epub 2020 Sep 10.
- Results publication: PubMed 33290635Elhadad MA, El-Negoumy E, Taalab MR, Ibrahim RS, Elsaka RO. The effect of topical chamomile in the prevention of chemotherapy-induced oral mucositis: A randomized clinical trial. Oral Dis. 2022 Jan;28(1):164-172. doi: 10.1111/odi.13749. Epub 2020 Dec 19.
- Results publication: PubMed 32062592de Lima VHS, de Oliveira-Neto OB, da Hora Sales PH, da Silva Torres T, de Lima FJC. Effectiveness of low-level laser therapy for oral mucositis prevention in patients undergoing chemoradiotherapy for the treatment of head and neck cancer: A systematic review and meta-analysis. Oral Oncol. 2020 Mar;102:104524. doi: 10.1016/j.oraloncology.2019.104524. Epub 2020 Feb 13.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low level diode laser, Chamomile and Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel in people with Chemotherapy Induced Oral Mucositis, run by Cairo University.
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 3 inclusion and 2 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 23 Jan 2024. 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. 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?
Results are not available in the source record.
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?
Discomfort and pain (time frame: On baseline, first, third, fifth, seventh, tenth and 14th day.). 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 NCT06214273, which also lists 4 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 23 Jan 2024.