Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05335434
Other study ID # 22-036
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 10, 2022
Est. completion date September 19, 2024

Study information

Verified date January 2024
Source Dana-Farber Cancer Institute
Contact Kentaro Ikeda, DDS,MPH
Phone 617-732-6570
Email kikeda4@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 19, 2024
Est. primary completion date June 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
THOR LX2.3 with LED Lollipop
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

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute THOR Photomedicine Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT02229136 - Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus Phase 2
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Enrolling by invitation NCT02662374 - Oral Hygiene Regimen in Patients on HCT Phase 4
Completed NCT00938080 - Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck Phase 1
Completed NCT00756951 - Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer Phase 2
Completed NCT00701688 - Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Phase 1
Not yet recruiting NCT05059613 - Thalidomide With or Without Probiotics in Radioactive Oral Mucositis N/A
Completed NCT04440930 - White Tea for Prevention of Chemotherapy Induced Mucositis N/A
Completed NCT05705622 - The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients N/A
Completed NCT02399228 - A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis Phase 2
Withdrawn NCT02589860 - Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
Active, not recruiting NCT01772706 - Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Completed NCT03689712 - ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients Phase 3
Terminated NCT02539342 - Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy Phase 3
Completed NCT02555501 - Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy Phase 3
Completed NCT01789658 - Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation N/A
Completed NCT00790322 - Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy Phase 3
Recruiting NCT00549952 - Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients N/A
Completed NCT00289003 - The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients Phase 2