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

NCT ID: NCT06625619

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-07

Study Completion Date

2025-12-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group I (Patients)

Patients have their medical records reviewed on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Group II (Nurses)

Nurses complete surveys on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annette Isozaki, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Annette Isozaki, MD

Role: CONTACT

626-359-8111

Facility Contacts

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Annette Isozaki

Role: primary

406-591-5801

Other Identifiers

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NCI-2024-01324

Identifier Type: REGISTRY

Identifier Source: secondary_id

23673

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23673

Identifier Type: -

Identifier Source: org_study_id

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