Oral Mucosal UlcerationNCT01307540
Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients
A study testing phototherapy in people with Oral Mucosal Ulceration and Oral Mucositis, run by Hadassah Medical Organization.
Trial summary
Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients. Methods: patients will be treated with either active light-emitting device or inactive light-emitting device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucosal Ulceration, Oral Mucositis, Oral Lesion
- What is being tested?
- phototherapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Dec 2009
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- No oral ulceration at baseline
- At risk for oral mucositis due to the conditioning regimen to HSCT
- Age above 18 years old
- Karnofsky score >60
- Agree to participate in the study (signed an informed consent)
Who cannot join
- Pregnant woman
- Well-founded doubt about the patient's jurisprudence
- Children
- Sensitivity to light or treated with drugs which are sensitizers to light
- Treatment with other experimental topical drug during the study period
About this study
Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients.
Methods: patients will be treated with either active light-emitting device or inactive light-emitting device. Daily treatment with light therapy will start at the beginning of the conditioning regimen and will last until day 21 post-transplant. Each daily treatment last about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a weekly basis.
Read the detailed description
Primary endpoint:
- Assessment of effectiveness of treatment with QRay1 in preventing oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT).
Secondary endpoint:
- Assessment of mucositis associated- pain relief.
- Assessment of safety of treatment with QRay1 (oral adverse events).
- Assessment of the patients' acceptance of the device.
Study design:
Double-blind, randomized, placebo-controlled, 2 groups (randomization ratio 1:1).
Duration of treatment:
Daily treatment. Study-treatment administration began at the initiation of conditioning regimen (visit 1) and continued to day 28 or at least until day 21 if the patient had no mucositis (WHO or OMAS = "0")
Light radiation dose:
60-70mW/cm2 (administered over 3 treatment areas), starting with 45 seconds per surface, increasing each day in intervals of 15 seconds, up to a maximum of 90 seconds per surface.
Evaluation plan:
Evaluation began before the conditioning regimen was initiated (visit 1) and continued weekly until day 28 or until day 21 if the patient had no mucositis. A follow-up evaluation was performed a month after discharge the patient. Unusual clinical presentation was addressed whenever observed.
Criteria for evaluation:
Primary efficacy variable:
- Rate of absent of mucositis at any of the visits using WHO scale for mucositis and OMAS.
Secondary efficacy variables:
- Severity of oral mucositis at any of the visits using WHO scale for mucositis and OMAS.
- Severity of oral pain at any of the visits using WHO scale for mucositis and OMAS.
- Safety (oral adverse events)
- Patients' acceptance of the study drug on an 11-step ladder. Others
- Compliance with standard oral care (chlorhexidine rinse, nystatin readymix, saline mouthwash)
- Conditions
- Oral Mucosal Ulceration, Oral Mucositis, Oral Lesion
- Being tested
- phototherapy
- Medical subject headings
- Oral Ulcer, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phototherapyDevice
Also called QRay1
low level light therapy, broad band light wavelengths.
| Study group | Role | What they receive |
|---|---|---|
| Active light therapy | Experimental | oral mucosa is exposed to a light source (broad band of wavelengths, 400-800 nm) Receives: Device: phototherapy |
| Inactive light therapy | Placebo comparator | Oral mucosa is exposed to a extremely low-intensity light which is assumed to have no effect. Receives: Device: phototherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startFeb 2007
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucosal UlcerationStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Prevention
- Allocation
- Randomised
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307540
- Sponsor's protocol ID
- HT3687
- Status last verified
- Jun 2010
- First submitted
- 1 Mar 2011
- Last updated
- 3 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients
- ClinicalTrials.gov ID
- NCT01307540
- Acronym / sponsor ID
- HT3687
- Conditions
- Oral Mucosal Ulceration, Oral Mucositis, Oral Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2009 (actual)
- First posted
- 3 Mar 2011 (estimated)
- 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.
Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients.
Methods: patients will be treated with either active light-emitting device or inactive light-emitting device. Daily treatment with light therapy will start at the beginning of the conditioning regimen and will last until day 21 post-transplant. Each daily treatment last about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a weekly basis.
Detailed description
Primary endpoint:
- Assessment of effectiveness of treatment with QRay1 in preventing oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT).
Secondary endpoint:
- Assessment of mucositis associated- pain relief.
- Assessment of safety of treatment with QRay1 (oral adverse events).
- Assessment of the patients' acceptance of the device.
Study design:
Double-blind, randomized, placebo-controlled, 2 groups (randomization ratio 1:1).
Duration of treatment:
Daily treatment. Study-treatment administration began at the initiation of conditioning regimen (visit 1) and continued to day 28 or at least until day 21 if the patient had no mucositis (WHO or OMAS = "0")
Light radiation dose:
60-70mW/cm2 (administered over 3 treatment areas), starting with 45 seconds per surface, increasing each day in intervals of 15 seconds, up to a maximum of 90 seconds per surface.
Evaluation plan:
Evaluation began before the conditioning regimen was initiated (visit 1) and continued weekly until day 28 or until day 21 if the patient had no mucositis. A follow-up evaluation was performed a month after discharge the patient. Unusual clinical presentation was addressed whenever observed.
Criteria for evaluation:
Primary efficacy variable:
- Rate of absent of mucositis at any of the visits using WHO scale for mucositis and OMAS.
Secondary efficacy variables:
- Severity of oral mucositis at any of the visits using WHO scale for mucositis and OMAS.
- Severity of oral pain at any of the visits using WHO scale for mucositis and OMAS.
- Safety (oral adverse events)
- Patients' acceptance of the study drug on an 11-step ladder. Others
- Compliance with standard oral care (chlorhexidine rinse, nystatin readymix, saline mouthwash)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active light therapy | Experimental | Device: phototherapyoral mucosa is exposed to a light source (broad band of wavelengths, 400-800 nm) |
| Inactive light therapy | Placebo comparator | Device: phototherapyOral mucosa is exposed to a extremely low-intensity light which is assumed to have no effect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- No oral ulceration at baseline
- At risk for oral mucositis due to the conditioning regimen to HSCT
- Age above 18 years old
- Karnofsky score >60
- Agree to participate in the study (signed an informed consent)
Key exclusion criteria (5 listed)
- Pregnant woman
- Well-founded doubt about the patient's jurisprudence
- Children
- Sensitivity to light or treated with drugs which are sensitizers to light
- Treatment with other experimental topical drug during the study period
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 |
|---|---|---|
| phototherapyAlso: QRay1low level light therapy, broad band light wavelengths. | Device | Active light therapy, Inactive light therapy |
Primary outcome
Not reported in the source record.
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 3 Mar 2011.
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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 study testing phototherapy in people with Oral Mucosal Ulceration and Oral Mucositis, run by Hadassah Medical Organization.
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 5 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 3 Mar 2011. 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. Some participants in this study may receive a placebo. 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.
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 3 Mar 2011.