NCT01307540CompletedNot Applicable
Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
Study Overview
Brief Summary
Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients.
Methods: patients will be treated with either active light-emitting device or inactive light-emitting device. Daily treatment with light therapy will start at the beginning of the conditioning regimen and will last until day 21 post-transplant. Each daily treatment last about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a weekly basis.
Detailed Description
Primary endpoint:
o Assessment of effectiveness of treatment with QRay1 in preventing oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT).
Secondary endpoint:
- Assessment of mucositis associated- pain relief.
- Assessment of safety of treatment with QRay1 (oral adverse events).
- Assessment of the patients' acceptance of the device.
Study design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •No oral ulceration at baseline
- •At risk for oral mucositis due to the conditioning regimen to HSCT
- •Age above 18 years old
- •Karnofsky score >60
- •Agree to participate in the study (signed an informed consent)
Exclusion Criteria
- •Pregnant woman
- •Well-founded doubt about the patient's jurisprudence
- •Sensitivity to light or treated with drugs which are sensitizers to light
- •Treatment with other experimental topical drug during the study period
Investigators
Similar Trials
Not yet recruiting
Not Applicable
A Clinical Trial of the Administration of Light Therapy to Prevent Mouth Sores in Children With CancerMucositis OralNCT06623305Medical College of Wisconsin50
Recruiting
Not Applicable
Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell TransplantationHematologic CancerNCT06260111Universidad del Desarrollo30
Completed
Phase 4
Photodynamic Therapy for Oral Leukoplakia and ErythroleukoplakiaOral LeukoplakiaNCT00155337National Taiwan University Hospital40
Terminated
Phase 2
UVB Phototherapy Treatment of Oral Chronic GVHDNCT00374257Brigham and Women's Hospital11
Terminated
Not Applicable
Prevention of Delirium After Bone Marrow TransplantationDeliriumNCT01700816Massachusetts General Hospital40