Oropharyngeal MucositisNCT02119897
Feasibility Study of Low Level Light Therapy for Prevention of Oropharyngeal Mucositis in Pediatric Transplants Patients
A study testing Low Level Light Therapy in people with Oropharyngeal Mucositis and Myeloablative Hematopoietic Cell Transplantation, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-versus-host disease… Read more about this study
- Who is it for?
- Ages 4 to 25 years
- Conditions the study is for
- Oropharyngeal Mucositis, Myeloablative Hematopoietic Cell Transplantation, Low Level Light Therapy
- What is being tested?
- Low Level Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Apr 2016
- 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 4 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Scheduled to undergo myeloablative conditioning followed by autologous or allogeneic hematopoietic cell transplantation at Boston Children's Hospital.
- 4 years of age to 25 years of age.
- WHO Oral Toxicity score of 0 at baseline evaluation (first day of conditioning).
- Ability to understand and the willingness to sign a written informed consent document (for patients under the age of 18 this applies to parent/guardian)
- Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.
Who cannot join
- Treatment with oral LLLT within 4 weeks of HCT.
- Participants may not be receiving any other agents intended for the prevention/management of mucositis (including palifermin and ice chips/cryotherapy).
- WHO ≥1 at baseline evaluation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Feasibility Study Evaluating Extraorally Delivered Low Level Light Therapy (LLLT) for the Prevention of Oropharyngeal Mucositis in Pediatric Patients Undergoing Myeloablative Hematopoietic Cell Transplantation
Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and suffering, increased utilization of opioid analgesics, and the need for intravenous or total parenteral nutritional support. Patients universally report OM as being the worst aspect of the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to treat the at risk tissues from an extraoral approach, enabling exposure of the oral, oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and requiring only minimal patient cooperation. In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy (LLLT) for the prevention of OM in children undergoing myeloablative HCT.
Read the detailed description
This is an open label, single treatment arm clinical pilot study. The study is targeted to enroll twelve evaluable patients
OBJECTIVES:
Primary
- Determine the feasibility of providing extraoral LLLT for prevention of OM in pediatric patients undergoing HCT
Secondary
- Determine the feasibility of collecting data using the WHO Oral Toxicity Scale and ChIMES in pediatric patients undergoing myeloablative HCT who are treated with extraoral LLLT for prevention of OM
- Evaluate the safety and tolerability of extraoral LLLT for prevention of OM in pediatric patients undergoing myeloablative HCT
- Conditions
- Oropharyngeal Mucositis, Myeloablative Hematopoietic Cell Transplantation, Low Level Light Therapy
- Being tested
- Low Level Light Therapy
- Keywords
- Oropharyngeal Mucositis, Myeloablative Hematopoietic Cell Transplantation, Low Level Light Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Light TherapyDevice
Also called THOR Model LX2M (THOR Photomedicine Ltd, Chesham, UK)
| Study group | Role | What they receive |
|---|---|---|
| Low Level Light Therapy (LLLT) | Experimental | * LLLT: The LLLT device will be positioned next to the face and neck for a total of 6 exposures: Right face, Midline face, Left face, Left neck, Midline neck, Right neck
* Dose per anatomic site 50mW/cm2, 60 sec = 3.0J/cm2
* Route: Extraoral
* Total Treatment Time (all sites): 6 min
* Schedule: Participants will be treated daily (including weekends and holidays) beginning on the first day of HCT conditioning and continuing through day +20 or hospital discharge if prior to day +20.
* Evaluation: Participants will undergo formal mucositis and toxicity assessments at baseline and daily from day -1 through day +20, with a final assessment on the last day of treatment. Receives: Device: Low Level Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT
Several measures will be collected to evaluate the overall feasibility of providing daily extraoral LLLT for children undergoing HSCT including:
- Accessibility and maneuverability of the LLLT device (transportation from storage site to hospital room, device weight)
- Administration of LLLT (device settings, positioning of device, delivery of therapy)
- Patient tolerability (level of comfort during treatments, compliance with daily therapy
- Proportion of days with therapy administered, as evidence by data submitted (goal is ≥75%)
- Ability to enroll at least 5 patients within the first 3 months (this pertains to the feasibility of study conduct, and not to the feasibility of the therapeutic approach)
Measured: 20 Days
Secondary outcomes (4)
Patient compliance with completing questionnaires
To address secondary the investigators, will calculate the following proportion: (number of times patients refused to complete one or both questionnaires) / (number of questionnaire completion timepoints), and place a 95% confidence interval on the proportion.
Measured: 2 Years
WHO Oral Toxicity Scale/ChIMES Instrument
To address secondary aim, the investigator, will analyze the data from the WHO Oral Toxicity Scale and the ChIMES instrument using the analytic methods specifically prescribed for these standardized instruments.
Measured: 2 Years
Toxicity measured using CTC Version
Measured: 2 Years
Dose-limiting toxicity
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal MucositisStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute
- Investigators
- Nathaniel Treister, DMD,DMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119897
- Sponsor's protocol ID
- 13-611
- Status last verified
- Jan 2017
- First submitted
- 9 Apr 2014
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Treister NS, London WB, Guo D, Malsch M, Verrill K, Brewer J, Margossian S, Duncan C. A Feasibility Study Evaluating Extraoral Photobiomodulation Therapy for Prevention of Mucositis in Pediatric Hematopoietic Cell Transplantation. Photomed Laser Surg. 2016 Apr;34(4):178-84. doi: 10.1089/pho.2015.4021. Epub 2016 Mar 16.
PubMed 26982624
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Evaluating Extraorally Delivered Low Level Light Therapy (LLLT) for the Prevention of Oropharyngeal Mucositis in Pediatric Patients Undergoing Myeloablative Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT02119897
- Acronym / sponsor ID
- 13-611
- Conditions
- Oropharyngeal Mucositis, Myeloablative Hematopoietic Cell Transplantation, Low Level Light Therapy
- Keywords
- Oropharyngeal Mucositis, Myeloablative Hematopoietic Cell Transplantation, Low Level Light Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Apr 2014 (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.
Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and suffering, increased utilization of opioid analgesics, and the need for intravenous or total parenteral nutritional support. Patients universally report OM as being the worst aspect of the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to treat the at risk tissues from an extraoral approach, enabling exposure of the oral, oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and requiring only minimal patient cooperation. In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy (LLLT) for the prevention of OM in children undergoing myeloablative HCT.
Detailed description
This is an open label, single treatment arm clinical pilot study. The study is targeted to enroll twelve evaluable patients
OBJECTIVES:
Primary
- Determine the feasibility of providing extraoral LLLT for prevention of OM in pediatric patients undergoing HCT
Secondary
- Determine the feasibility of collecting data using the WHO Oral Toxicity Scale and ChIMES in pediatric patients undergoing myeloablative HCT who are treated with extraoral LLLT for prevention of OM
- Evaluate the safety and tolerability of extraoral LLLT for prevention of OM in pediatric patients undergoing myeloablative HCT
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Level Light Therapy (LLLT) | Experimental | Device: Low Level Light Therapy* LLLT: The LLLT device will be positioned next to the face and neck for a total of 6 exposures: Right face, Midline face, Left face, Left neck, Midline neck, Right neck * Dose per anatomic site 50mW/cm2, 60 sec = 3.0J/cm2 * Route: Extraoral * Total Treatment Time (all sites): 6 min * Schedule: Participants will be treated daily (including weekends and holidays) beginning on the first day of HCT conditioning and continuing through day +20 or hospital discharge if prior to day +20. * Evaluation: Participants will undergo formal mucositis and toxicity assessments at baseline and daily from day -1 through day +20, with a final assessment on the last day of treatment. |
Who may qualify
- Ages
- 4 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Scheduled to undergo myeloablative conditioning followed by autologous or allogeneic hematopoietic cell transplantation at Boston Children's Hospital.
- 4 years of age to 25 years of age.
- WHO Oral Toxicity score of 0 at baseline evaluation (first day of conditioning).
- Ability to understand and the willingness to sign a written informed consent document (for patients under the age of 18 this applies to parent/guardian)
- Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Treatment with oral LLLT within 4 weeks of HCT.
- Participants may not be receiving any other agents intended for the prevention/management of mucositis (including palifermin and ice chips/cryotherapy).
- WHO ≥1 at baseline evaluation.
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 Light TherapyAlso: THOR Model LX2M (THOR Photomedicine Ltd, Chesham, UK) | Device | Low Level Light Therapy (LLLT) |
Primary outcome
The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT
Time frame: 20 Days
Several measures will be collected to evaluate the overall feasibility of providing daily extraoral LLLT for children undergoing HSCT including: * Accessibility and maneuverability of the LLLT device (transportation from storage site to hospital room, device weight) * Administration of LLLT (device settings, positioning of device, delivery of therapy) * Patient tolerability (level of comfort during treatments, compliance with daily therapy * Proportion of days with therapy administered, as evidence by data submitted (goal is ≥75%) * Ability to enroll at least 5 patients within the first 3 months (this pertains to the feasibility of study conduct, and not to the feasibility of the therapeutic approach)
4 secondary outcomes
Patient compliance with completing questionnaires
Time frame: 2 Years
WHO Oral Toxicity Scale/ChIMES Instrument
Time frame: 2 Years
Toxicity measured using CTC Version
Time frame: 2 Years
Dose-limiting toxicity
Time frame: 2 Years
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 26 Jan 2017.
- Results publication: PubMed 26982624Treister NS, London WB, Guo D, Malsch M, Verrill K, Brewer J, Margossian S, Duncan C. A Feasibility Study Evaluating Extraoral Photobiomodulation Therapy for Prevention of Mucositis in Pediatric Hematopoietic Cell Transplantation. Photomed Laser Surg. 2016 Apr;34(4):178-84. doi: 10.1089/pho.2015.4021. Epub 2016 Mar 16.
- 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.
Nathaniel Treister, DMD,DMSc principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Light Therapy in people with Oropharyngeal Mucositis and Myeloablative Hematopoietic Cell Transplantation, run by Dana-Farber Cancer Institute at 2 sites in United States.
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 3 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT (time frame: 20 Days). 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 NCT02119897, which also lists 1 linked publication.
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 26 Jan 2017.