Oral MucositisNCT05175222
Assessment of Efficacy of LightWalker (Nd:Yag, Er:Yag) Laser Therapy on Incidence, Severity and Duration of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT). Prospective Randomized Open-label Study
A study testing Laser therapy in people with Oral Mucositis and Bone Marrow Transplant Complications, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Oral mucositis (OM) is a common and debilitating adverse effect of conditioning regimens in patients undergoing hematopoietic cell transplantation (HCT). It is treated symptomatically with pain relief medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Bone Marrow Transplant Complications
- What is being tested?
- Laser therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2019to 11 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written, informed consent for participation in the study
- oral sanation
- myeloablative conditioning
Who cannot join
- lack of patient's consent
- pathological lesions in oral cavity on the first day of conditioning regimen
- renal failure
- active infection
Trial locations and contacts
1 site in 1 country.
About this study
Oral mucositis (OM) is a common and debilitating adverse effect of conditioning regimens in patients undergoing hematopoietic cell transplantation (HCT). It is treated symptomatically with pain relief medications. The use of low-level laser therapy (LLLT) to prevent tissue damage has been postulated for almost forty years, however, there are only a few reports concerning old generation lasers in mucositis prophylaxis in HCT recipients. Here we hypothesized, that a new generation LLLT (Nd: YAG Fotona LightWalker®) laser may be an effective prophylaxis in shortening and reducing the severity of this complication.
Read the detailed description
This clinical trial is a prospective, randomized open-label study. All patients qualified to hematopoietic stem cell transplantation will be informed about possibility of taking part in this study. Patients who meet the inclusion criteria will be enrolled and randomized into two groups.
Patients in the first group will receive standard supportive treatment. Patients in the second group, except for the supportive treatment (as in the first group), will additionally receive prophylactic laser therapy of oral mucosa during high-dose chemotherapy conditioning before HSCT. Patients will undergo laser treatment daily from the first day of conditioning regimen till the second day after stem cell transfusion. The procedure will be carried out by trained staff at the bedside.
Severity of oral mucositis and pain will be measured in both groups on days 0, 4, 7, 11, 14, 18 and 21 after HSCT.
Severity of oral mucositis will be assessed according to five-point WHO scale Pain intensity will be measured on the basis of ten-point NRS scale.
In addition, the need for opioid analgesics and total parenteral nutrition will be evaluated.
Photographic documentation will be made on days -7, 0, 7, 14, 21. All obtained results will be collected in a database and subjected to statistical analysis. Additional analysis will be carried out during the study to evaluate whether the differences in results between studied groups reach statistical significance with less than a predetermined number of patients.
- Being tested
- Laser therapy
- Keywords
- oral mucositis, low-level laser therapy, biomodulation, hematopoietic stem cell transplantation
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyRadiation
Patients receive laser therapy in 7 points in oral cavity every day from the first day of conditioning chemotherapy till the second day post HSCT. Each point is irradiated for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Patients receive low-level laser therapy with LightWalker laser from the first day of conditioning chemotherapy till +2 day post hematopoietic stem cell transplantation. Additionally, standard supportive care is introduced. Receives: Radiation: Laser therapy |
| Control | No intervention | Patients are observed and receive standard supportive care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of oral mucositis
Duration of oral mucositis duration in days measured in both groups
Measured: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Severity of oral mucositis
Evaluation of pain according to NRS scale
Measured: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Secondary outcomes (2)
Need for opioid analgesics calculated
Opioid analgesic need assessed in days
Measured: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Length of most severe pain
Number of days of most severe pain according to NRS scale
Measured: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Fotona d.o.o.
- Responsible party
- Sponsor
- Investigators
- Anna Irga-Staniukiewicz, MD, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175222
- Sponsor's protocol ID
- BIOMOD-HSCT1
- Status last verified
- Dec 2021
- First submitted
- 14 Dec 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of LightWalker (Nd:Yag, Er:Yag) Laser Therapy on Incidence, Severity and Duration of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT). Prospective Randomized Open-label Study
- ClinicalTrials.gov ID
- NCT05175222
- Acronym / sponsor ID
- BIOMOD-HSCT1
- Keywords
- oral mucositis, low-level laser therapy, biomodulation, hematopoietic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- Fotona d.o.o.
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 3 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.
Oral mucositis (OM) is a common and debilitating adverse effect of conditioning regimens in patients undergoing hematopoietic cell transplantation (HCT). It is treated symptomatically with pain relief medications. The use of low-level laser therapy (LLLT) to prevent tissue damage has been postulated for almost forty years, however, there are only a few reports concerning old generation lasers in mucositis prophylaxis in HCT recipients. Here we hypothesized, that a new generation LLLT (Nd: YAG Fotona LightWalker®) laser may be an effective prophylaxis in shortening and reducing the severity of this complication.
Detailed description
This clinical trial is a prospective, randomized open-label study. All patients qualified to hematopoietic stem cell transplantation will be informed about possibility of taking part in this study. Patients who meet the inclusion criteria will be enrolled and randomized into two groups.
Patients in the first group will receive standard supportive treatment. Patients in the second group, except for the supportive treatment (as in the first group), will additionally receive prophylactic laser therapy of oral mucosa during high-dose chemotherapy conditioning before HSCT. Patients will undergo laser treatment daily from the first day of conditioning regimen till the second day after stem cell transfusion. The procedure will be carried out by trained staff at the bedside.
Severity of oral mucositis and pain will be measured in both groups on days 0, 4, 7, 11, 14, 18 and 21 after HSCT.
Severity of oral mucositis will be assessed according to five-point WHO scale Pain intensity will be measured on the basis of ten-point NRS scale.
In addition, the need for opioid analgesics and total parenteral nutrition will be evaluated.
Photographic documentation will be made on days -7, 0, 7, 14, 21. All obtained results will be collected in a database and subjected to statistical analysis. Additional analysis will be carried out during the study to evaluate whether the differences in results between studied groups reach statistical significance with less than a predetermined number of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Radiation: Laser therapyPatients receive low-level laser therapy with LightWalker laser from the first day of conditioning chemotherapy till +2 day post hematopoietic stem cell transplantation. Additionally, standard supportive care is introduced. |
| Control | No intervention | –Patients are observed and receive standard supportive care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written, informed consent for participation in the study
- oral sanation
- myeloablative conditioning
Key exclusion criteria (4 listed)
- lack of patient's consent
- pathological lesions in oral cavity on the first day of conditioning regimen
- renal failure
- active infection
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 |
|---|---|---|
| Laser therapyPatients receive laser therapy in 7 points in oral cavity every day from the first day of conditioning chemotherapy till the second day post HSCT. Each point is irradiated for 1 minute. | Radiation | Laser |
Primary outcome
Duration of oral mucositis
Time frame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Duration of oral mucositis duration in days measured in both groups
Severity of oral mucositis
Time frame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Evaluation of pain according to NRS scale
2 secondary outcomes
Need for opioid analgesics calculated
Time frame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Length of most severe pain
Time frame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
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 Jan 2022.
- Individual participant dataSharing planned: Yes
Related trials for Oral Mucositis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
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.
Anna Irga-Staniukiewicz, MD principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy in people with Oral Mucositis and Bone Marrow Transplant Complications, run by Medical University of Gdansk at 1 site in Poland.
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 4 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 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 Poland. 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?
Duration of oral mucositis (time frame: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation). 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 3 Jan 2022.