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Photobiomodulation

Photobiomodulation Therapy for Mouth Sores from Bone Marrow Transplant

N/A
Recruiting
Led By Kentaro Ikeda, DDS, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 days
Awards & highlights

Study Summary

This trial is evaluating the use of a device called the THOR LX2.3 with LED Lollipop for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). This device uses light to help prevent mucositis, a common side effect of alloHCT.

Who is the study for?
This trial is for adults over 18 who are about to receive a bone marrow transplant and have agreed to the study. It's not for those who've had photobiomodulation therapy recently, radiation on their head or neck, issues with light sensitivity, or will be treated with palifermin.Check my eligibility
What is being tested?
The trial tests if a special LED device called THOR LX2.3 can prevent mouth sores in patients getting intense chemotherapy before a bone marrow transplant. Participants will use this LED Lollipop daily during treatment.See study design
What are the potential side effects?
Potential side effects of using the LED Lollipop may include discomfort in the mouth or changes in taste sensation, but since it's non-invasive, serious side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for a specific bone marrow transplant with FluBu4 and Tac-Mtx.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of severe Oral Mucositis

Trial Design

1Treatment groups
Experimental Treatment
Group I: INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCTExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,853 Total Patients Enrolled
THOR Photomedicine LtdUNKNOWN
Kentaro Ikeda, DDS, MPHPrincipal InvestigatorBrigham and Women's Hospital

Media Library

THOR LX2.3 with LED Lollipop (Photobiomodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05335434 — N/A
Mouth Sore Research Study Groups: INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT
Mouth Sore Clinical Trial 2023: THOR LX2.3 with LED Lollipop Highlights & Side Effects. Trial Name: NCT05335434 — N/A
THOR LX2.3 with LED Lollipop (Photobiomodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05335434 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment ongoing for this trial?

"Affirmative. According to clinicaltrials.gov, the study is currently enrolling participants with its initial posting on June 10th 2022 and most recent update being June 27th 2022. They are looking for 20 patients from 1 medical site."

Answered by AI

What is the size of the sample pool for this clinical endeavor?

"Indeed, the information hosted on clinicaltrials.gov reveals that this study is actively recruiting patients. Initially posted on June 10th 2022 and recently updated June 27th 2022, it is seeking 20 participants from one site in particular."

Answered by AI
~2 spots leftby Jun 2024