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

Dana-Farber Cancer Institute

Status: Enrolling

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

Treatments: Device: THOR LX2.3 with LED Lollipop

Study type: Interventional

Funder types: Other

Identifiers

NCT05335434

22-036

Details and patient eligibility

About

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

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT

Experimental group

Description:

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

Treatment:

Device: THOR LX2.3 with LED Lollipop