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Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307540
First Posted: March 3, 2011
Last Update Posted: March 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose

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.


Condition Intervention
Oral Mucosal Ulceration Oral Mucositis Oral Lesion Device: phototherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients

Further study details as provided by Hadassah Medical Organization:

Enrollment: 20
Study Start Date: February 2007
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active light therapy
oral mucosa is exposed to a light source (broad band of wavelengths, 400-800 nm)
Device: phototherapy
low level light therapy, broad band light wavelengths.
Other Name: QRay1
Placebo Comparator: Inactive light therapy
Oral mucosa is exposed to a extremely low-intensity light which is assumed to have no effect.
Device: phototherapy
low level light therapy, broad band light wavelengths.
Other Name: QRay1

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:

Double-blind, randomized, placebo-controlled, 2 groups (randomization ratio 1:1).

Duration of treatment:

Daily treatment. Study-treatment administration began at the initiation of conditioning regimen (visit 1) and continued to day 28 or at least until day 21 if the patient had no mucositis (WHO or OMAS = "0")

Light radiation dose:

60-70mW/cm2 (administered over 3 treatment areas), starting with 45 seconds per surface, increasing each day in intervals of 15 seconds, up to a maximum of 90 seconds per surface.

Evaluation plan:

Evaluation began before the conditioning regimen was initiated (visit 1) and continued weekly until day 28 or until day 21 if the patient had no mucositis. A follow-up evaluation was performed a month after discharge the patient. Unusual clinical presentation was addressed whenever observed.

Criteria for evaluation:

Primary efficacy variable:

o Rate of absent of mucositis at any of the visits using WHO scale for mucositis and OMAS.

Secondary efficacy variables:

  • Severity of oral mucositis at any of the visits using WHO scale for mucositis and OMAS.
  • Severity of oral pain at any of the visits using WHO scale for mucositis and OMAS.
  • Safety (oral adverse events)
  • Patients' acceptance of the study drug on an 11-step ladder. Others
  • Compliance with standard oral care (chlorhexidine rinse, nystatin readymix, saline mouthwash)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
  • Children
  • Sensitivity to light or treated with drugs which are sensitizers to light
  • Treatment with other experimental topical drug during the study period
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Sharon Elad, PI, Hadassah University Medical Center
ClinicalTrials.gov Identifier: NCT01307540     History of Changes
Other Study ID Numbers: HT3687
First Submitted: March 1, 2011
First Posted: March 3, 2011
Last Update Posted: March 3, 2011
Last Verified: June 2010

Additional relevant MeSH terms:
Mucositis
Stomatitis
Oral Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases