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NCT Number: NCT06625619

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. Xerostomia

    Time frame: Up to 22 days or until discharge, whichever came first

    Xerostomia severity (0-10 scale)

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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