Hematopoietic and Lymphatic System NeoplasmNCT06625619
On the BRINK: PhotoBiomodulation (PBM) for Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell TRansplant (HSCT) - Implementing the Evidence & Discovering New Knowledge
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This study evaluates mucositis and other oral symptoms in patients undergoing photobiomodulation in patients undergoing hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 24 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are undergoing HSCT and nurses who administer PBM
Who may be able to join
- PATIENTS:
- Age: ≥ 18 years
- Undergoing allogeneic HSCT - cases where PBM was used and cases where PBM was not used
- NURSES:
- Nurses who administer PBM
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Group I (Patients) | Patients have their medical records reviewed on study. Receives: Other: Non-Interventional Study | |
| Group II (Nurses) | Nurses complete surveys on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucositis according to the World Health Organization (WHO) Scale
WHO scale is a combined patient-reported and clinician assessed rating scale that ranges from 0 ( no oral mucositis) to IV (Life threatening mucosistis).
Measured: Up to 22 days or until discharge, whichever came first
Average oral pain
Patient is asked to rate their pain on a 0 - 10 scale with 0 being no pain and 10 being the worst possible pain.
Measured: Up to 22 days or until discharge, whichever came first
Taste
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.
Measured: Up to 22 days or until discharge, whichever came first
Xerostomia
Xerostomia severity (0-10 scale)
Measured: Up to 22 days or until discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start7 Oct 2024
- Primary completion24 Nov 2026 (estimated)
- Study completion24 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Annette Isozaki, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625619
- Sponsor's protocol ID
- 23673
- Other IDs
- NCI-2024-01324, 23673, P30CA033572
- Status last verified
- Jan 2026
- First submitted
- 23 Aug 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On the BRINK: PhotoBiomodulation (PBM) for Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell TRansplant (HSCT) - Implementing the Evidence &Amp; Discovering New Knowledge
- ClinicalTrials.gov ID
- NCT06625619
- Acronym / sponsor ID
- 23673
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 24 Nov 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates mucositis and other oral symptoms in patients undergoing photobiomodulation in patients undergoing hematopoietic stem cell transplantation.
Detailed description
PRIMARY OBJECTIVE:
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Patients) | – | Other: Non-Interventional StudyPatients have their medical records reviewed on study. |
| Group II (Nurses) | – | Other: Non-Interventional StudyNurses complete surveys on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are undergoing HSCT and nurses who administer PBM
Key inclusion criteria (5 listed)
- PATIENTS:
- Nurses who administer PBM
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Group I (Patients), Group II (Nurses) |
Primary outcome
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).
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.
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.
Xerostomia
Time frame: Up to 22 days or until discharge, whichever came first
Xerostomia severity (0-10 scale)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Isozaki, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucositis according to the World Health Organization (WHO) Scale (time frame: Up to 22 days or until discharge, whichever came first). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.