Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT05335434
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
The name of the study device involved in this study is:
\- THOR LX2.3 with LED Lollipop
Detailed 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: