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

Recruiting

• Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06625619
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Study Start: 2024-10-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-12-05
• Study Completion: 2025-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I (Patients)	Non-Interventional Study	Patients have their medical records reviewed on study.
Group II (Nurses)	Non-Interventional Study	Nurses complete surveys on study.

Primary Outcome Measures

Name	Time	Method
Mucositis according to the World Health Organization (WHO) Scale	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	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	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	Up to 22 days or until discharge, whichever came first	Xerostomia severity (0-10 scale)

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States