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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-01324 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23673 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study evaluates mucositis and other oral symptoms in patients undergoing photobiomodulation in patients undergoing hematopoietic stem cell transplantation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Patients) | Patients have their medical records reviewed on study. |
| |
| Group II (Nurses) | Nurses complete surveys on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
PATIENTS:
NURSES:
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Patients who are undergoing HSCT and nurses who administer PBM
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| Name | Affiliation | Role |
|---|---|---|
| Annette Isozaki, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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