On the BRINK: PhotoBiomodulation (PBM) for Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell TRansplant (HSCT) - Implementing the Evidence & Discovering New Knowledge

January 27, 2026 updated by: City of Hope Medical Center

On the BRINK: PhotoBiomodulation (PBM) for Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell TRansplant (HSCT) - Implementing the Evidence &Amp; Discovering New Knowledge

This study evaluates mucositis and other oral symptoms in patients undergoing photobiomodulation in patients undergoing hematopoietic stem cell transplantation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Examine mucositis severity, oral pain, taste changes, and xerostomia in patients undergoing PBM, a new standard of care for oral mucositis.

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

GROUP I: Patients have their medical records reviewed on study.

GROUP II: Nurses complete surveys on study.

Study Type

Observational

Enrollment (Estimated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who are undergoing HSCT and nurses who administer PBM

Description

Inclusion Criteria:

  • PATIENTS:

    • Age: ≥ 18 years
    • Undergoing allogeneic HSCT - cases where PBM was used and cases where PBM was not used

NURSES:

  • Nurses who administer PBM

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I (Patients)
Patients have their medical records reviewed on study.
Other: Non-Interventional Study
Non-interventional study
Group II (Nurses)
Nurses complete surveys on study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucositis according to the World Health Organization (WHO) Scale
Time Frame: Up to 22 days or until discharge, whichever came first
WHO scale is a combined patient-reported and clinician assessed rating scale that ranges from 0 ( no oral mucositis) to IV (Life threatening mucosistis).
Up to 22 days or until discharge, whichever came first
Average oral pain
Time Frame: Up to 22 days or until discharge, whichever came first
Patient is asked to rate their pain on a 0 - 10 scale with 0 being no pain and 10 being the worst possible pain.
Up to 22 days or until discharge, whichever came first
Taste
Time Frame: Up to 22 days or until discharge, whichever came first
Taste according to the Chemotherapy Induced Taste Alteration Scale (CiTAS) which is an 18-item scale that measures four dimensions of taste: decline in basic taste, discomfort, phantogeusia and parageusia, and general taste alterations. Items are stated on a Likert scale 1 - 5 (where 1 = no difficulty or absence of the disturbance and 5 = maximum difficulty or disturbance.
Up to 22 days or until discharge, whichever came first
Xerostomia
Time Frame: Up to 22 days or until discharge, whichever came first
Xerostomia severity (0-10 scale)
Up to 22 days or until discharge, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Annette Isozaki, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2024

Primary Completion (Estimated)

November 24, 2026

Study Completion (Estimated)

November 24, 2026

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23673 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2024-01324 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe