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

NCT06625619 | Active Not Recruiting DMC

• 3 other identifiers: 23673NCI-2024-01324P30CA033572
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  Up to 22 days or until discharge, whichever came first

• Xerostomia

  Xerostomia severity (0-10 scale)

  Up to 22 days or until discharge, whichever came first

Study Arms (2)

Group I (Patients)

Patients have their medical records reviewed on study.

Other: Non-Interventional Study

Group II (Nurses)

Nurses complete surveys on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Group I (Patients); Group II (Nurses)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are undergoing HSCT and nurses who administer PBM

You may qualify if:

• PATIENTS:
• Age: ≥ 18 years
• Undergoing allogeneic HSCT - cases where PBM was used and cases where PBM was not used
• NURSES:
• Nurses who administer PBM

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Study Officials

• Annette Isozaki, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: October 3, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): November 24, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)