MucositisNCT05181943
Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis
A study testing Simpler diode laser and Conventional symptomatic treatment in people with Mucositis, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Mucositis
- What is being tested?
- Simpler diode laser and Conventional symptomatic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Dec 2021
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children diagnosed with mucositis and receiving chemotherapy
Who cannot join
- diabetes
- trismus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial
The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia
- Conditions
- Mucositis
- Being tested
- Simpler diode laser, Conventional symptomatic treatment
- Keywords
- mucositis - leukemia - chemotherapy
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simpler diode laserDevice
Non-contacting irradiation for 30 seconds on three intraoral sites repeated four times
Conventional symptomatic treatmentDrug
Conventional treatment using oracure, BBC spray, miconaz three times daily
| Study group | Role | What they receive |
|---|---|---|
| Laser irradiation (Test group) | Experimental | laser irradiation over lesion Receives: Device: Simpler diode laser |
| Conventional treatment (Control group | Active comparator | Not described Receives: Drug: Conventional symptomatic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain level
Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level.
Measured: up to 2 weeks
Oral mucositis lesion size
This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake.
Grade3: Confluent ulceration that affect the solid food intake and require liquid diet.
Grade 4: The patient requires parenteral nutrition.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Oct 2020
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
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.
- More trials run by Alexandria 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farida Reayd, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181943
- Sponsor's protocol ID
- 332021
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05181943
- Acronym / sponsor ID
- 332021
- Conditions
- Mucositis
- Keywords
- mucositis - leukemia - chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 10 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.
The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser irradiation (Test group) | Experimental | Device: Simpler diode laserlaser irradiation over lesion |
| Conventional treatment (Control group | Active comparator | Drug: Conventional symptomatic treatment |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children diagnosed with mucositis and receiving chemotherapy
Key exclusion criteria (2 listed)
- diabetes
- trismus
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 |
|---|---|---|
| Simpler diode laserNon-contacting irradiation for 30 seconds on three intraoral sites repeated four times | Device | Laser irradiation (Test group) |
| Conventional symptomatic treatmentConventional treatment using oracure, BBC spray, miconaz three times daily | Drug | Conventional treatment (Control group |
Primary outcome
Self-reported pain level
Time frame: up to 2 weeks
Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level.
Oral mucositis lesion size
Time frame: up to 2 weeks
This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake. Grade3: Confluent ulceration that affect the solid food intake and require liquid diet. Grade 4: The patient requires parenteral nutrition.
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 10 Jan 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simpler diode laser and Conventional symptomatic treatment in people with Mucositis, run by Alexandria 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 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: finished, as of the sponsor's last update on 10 Jan 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.
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?
Self-reported pain level (time frame: up to 2 weeks). The study lists 2 primary outcomes in all. 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 10 Jan 2022.