Oral Mucositis (Ulcerative)NCT04493879
Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis
A study testing Bioptron Light Therapy (BLT) in people with Oral Mucositis (Ulcerative), run by Cairo University at 1 site in Egypt.
Trial summary
The study aimed to study the effect of Bioptron light therapy (BLT) on oral mucositis after receiving chemotherapy in patients with head and neck cancer,Oral mucositis (OM) is a common and severe acute side-effect of many oncologic treatments, especially in patients treated for head and neck cancer. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Oral Mucositis (Ulcerative)
- What is being tested?
- Bioptron Light Therapy (BLT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2019to 20 Aug 2019
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cancer patients (head \&neck) receiving chemotherapy \& radiotherapy
- Males and females
- Age ranged from 35-55 years
- All patients capable of understanding the study assessment method and willing to complete the current study
- Patients free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .
Who cannot join
- Patients suffering from immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
The study aimed to study the effect of Bioptron light therapy (BLT) on oral mucositis after receiving chemotherapy in patients with head and neck cancer,Oral mucositis (OM) is a common and severe acute side-effect of many oncologic treatments, especially in patients treated for head and neck cancer. It affects quality of life and require supportive care and proper treatment plane.
This study had been conducted on thirty cancer patients (head \&neck) receiving chemotherapy \& radiotherapy (males and females) with oral mucositis with ulceration and pain(grade 2 and more), their age ranged from 35 to 55 years, capable of understanding the study assessment method and willing to complete the current study, they were free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes mellitus. Patients were randomly allocated from patients from the National Cancer Institute, Cairo University. Group A (BLT group): This group consisted of 15 patients receiving BLT for about 10 minutes every day for thirty days in addition to routine oral mucositis medical care (Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections), Group B (Control group): This group consisted of 15 patients receiving daily routine oral mucositis medical care(Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections) for thirty days The methods of evaluation in the current study were the WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS). At the same time, the treatment equipment was the polarized light therapy device Bioptron Compact III (PAG-860 manufactured in Switzerland) Assessment by WHO oral mucositis scale and (OMS) and (CTCS) were used before treatment and after treatment to measure improvement in oral mucositis.
The results of WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS) were assessed first at the beginning of the study and one month after the end of the study; calculation of mean, standard deviation, minimum and maximum for each group was done by descriptive statistics, means comparison between the two groups pre and post-application and within each group was made using The t-test. With a level of significance Alpha point of 0.05
- Conditions
- Oral Mucositis (Ulcerative)
- Being tested
- Bioptron Light Therapy (BLT)
- Medical subject headings
- Stomatitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioptron Light Therapy (BLT)Other
BLT for 30 days 10 minutes every day. The treatment points displayed were: one point in the right jugal mucosa, one point in the left jugal mucosa, one point in the lower lip 's inner mucosa, analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections)
| Study group | Role | What they receive |
|---|---|---|
| Bioptron Light Therapy (BLT) group | Experimental | Received Bioptron Light Therapy (BLT) ten minutes every day for one month plus the routine medical treatment of oral mucositis(Analgesics, anti-inflammatory medication and antimicrobial therapy for any new mouth infections Receives: Other: Bioptron Light Therapy (BLT) |
| Routine medical care group | Experimental | Received only the routine medical care of oral mucositis for one month this consists of analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections Receives: Other: Bioptron Light Therapy (BLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Ulceration
WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start10 Jun 2019
- Primary completion20 Jul 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis (Ulcerative)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
- Investigators
- Marwa Eid, Principal investigator, Ass.Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493879
- Sponsor's protocol ID
- 68
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis
- ClinicalTrials.gov ID
- NCT04493879
- Acronym / sponsor ID
- 68
- Conditions
- Oral Mucositis (Ulcerative)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 30 Jul 2020 (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 study aimed to study the effect of Bioptron light therapy (BLT) on oral mucositis after receiving chemotherapy in patients with head and neck cancer,Oral mucositis (OM) is a common and severe acute side-effect of many oncologic treatments, especially in patients treated for head and neck cancer. It affects quality of life and require supportive care and proper treatment plane.
This study had been conducted on thirty cancer patients (head \&neck) receiving chemotherapy \& radiotherapy (males and females) with oral mucositis with ulceration and pain(grade 2 and more), their age ranged from 35 to 55 years, capable of understanding the study assessment method and willing to complete the current study, they were free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes mellitus. Patients were randomly allocated from patients from the National Cancer Institute, Cairo University. Group A (BLT group): This group consisted of 15 patients receiving BLT for about 10 minutes every day for thirty days in addition to routine oral mucositis medical care (Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections), Group B (Control group): This group consisted of 15 patients receiving daily routine oral mucositis medical care(Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections) for thirty days The methods of evaluation in the current study were the WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS). At the same time, the treatment equipment was the polarized light therapy device Bioptron Compact III (PAG-860 manufactured in Switzerland) Assessment by WHO oral mucositis scale and (OMS) and (CTCS) were used before treatment and after treatment to measure improvement in oral mucositis.
The results of WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS) were assessed first at the beginning of the study and one month after the end of the study; calculation of mean, standard deviation, minimum and maximum for each group was done by descriptive statistics, means comparison between the two groups pre and post-application and within each group was made using The t-test. With a level of significance Alpha point of 0.05
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioptron Light Therapy (BLT) group | Experimental | Other: Bioptron Light Therapy (BLT)Received Bioptron Light Therapy (BLT) ten minutes every day for one month plus the routine medical treatment of oral mucositis(Analgesics, anti-inflammatory medication and antimicrobial therapy for any new mouth infections |
| Routine medical care group | Experimental | Other: Bioptron Light Therapy (BLT)Received only the routine medical care of oral mucositis for one month this consists of analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Cancer patients (head \&neck) receiving chemotherapy \& radiotherapy
- Males and females
- Age ranged from 35-55 years
- All patients capable of understanding the study assessment method and willing to complete the current study
- Patients free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .
Key exclusion criteria (2 listed)
- Patients suffering from immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .
- Cognitive impairment
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 |
|---|---|---|
| Bioptron Light Therapy (BLT)BLT for 30 days 10 minutes every day. The treatment points displayed were: one point in the right jugal mucosa, one point in the left jugal mucosa, one point in the lower lip 's inner mucosa, analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections) | Other | Bioptron Light Therapy (BLT) group, Routine medical care group |
Primary outcome
Oral Ulceration
Time frame: 30 days
WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS)
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 30 Jul 2020.
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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.
Marwa Eid principal investigator
Ass.Prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioptron Light Therapy (BLT) in people with Oral Mucositis (Ulcerative), run by Cairo 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 5 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 30 Jul 2020. 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?
Oral Ulceration (time frame: 30 days). 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 30 Jul 2020.