Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation

Study Overview
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Brief Summary
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This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device. The name of the study device involved in this study is: - THOR LX2.3 with LED Lollipop

Detailed Description
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As part of a transplant procedure patients will receive chemotherapy in a conditioning regimen in preparation of alloHCT as well as immunosuppressive medications to help prevent graft-versus-host disease (GVHD prophylaxis). Together, these treatments will put patients at risk for developing side effects. A common side effect is oral mucositis (OM), in which mouth sores develop making eating and speaking difficult and painful. Photobiomodulation therapy (PBMT) is a light-based therapy that reduces inflammation and enhances wound healing. PBMT delivered inside the mouth has been shown to reduce OM in patients undergoing alloHCT. The name of the study device involved in this study is: - THOR LX2.3 with LED Lollipop This research study is a Pilot Study, which is the first time that investigators are examining this LED based intraoral PBMT. The U.S. Food and Drug Administration (FDA) has not approved PBMT for this specific disease but it has been approved for other uses. The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations. Participants will receive study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first. It is expected that about 20 people will take part in this research study

Official Title
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A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation

Conditions
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Myeloablative Allogeneic Hematopoietic Cell Transplantation, Intraoral Photobiomodulation Therapy, Oral Mucositis, Mucosal Ulcer

Intervention / Treatment
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* Device: THOR LX2.3 with LED Lollipop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis. Age ≥18 years. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participants who have had treatment with intraoral PBMT within four weeks of admission for HSCT. Participants who have a history of radiation therapy to the head and neck. Participants who have a history of photosensitivity or underlying disease with known photosensitivity. Participants who are planned to receive palifermin for OM prevention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT<br>The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations. Participants will receive the study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first -THOR LX2.3 with LED Lollipop | Device: THOR LX2.3 with LED Lollipop<br>* The intraoral PBMT device will be placed inside of the mouth to deliver the therapeutic light. Each treatment is approximately 2-3 minutes in duration. PBMT will be administered daily starting from the start of conditioning through day +20, or discharge if prior to day +20, with 27 consecutive days defined as a maximum PBMT treatment duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of severe Oral Mucositis | Defined as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported | 20 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myeloablative Allogeneic Hematopoietic Cell Transplantation (HCT), Intraoral Photobiomodulation Therapy, Oral Mucositis, Mucosal Ulcer