Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnnette Isozaki, MD
City of Hope Medical Center
Outcome results
None listed