Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients

March 1, 2011 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • QRay1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (Estimate)

March 3, 2011

Study Record Updates

Last Update Posted (Estimate)

March 3, 2011

Last Update Submitted That Met QC Criteria

March 1, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT3687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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