Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01307540
First received: March 1, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Sharon Elad, PI, Hadassah University Medical Center
ClinicalTrials.gov Identifier: NCT01307540     History of Changes
Other Study ID Numbers: HT3687
Study First Received: March 1, 2011
Last Updated: March 1, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Oral Ulcer
Stomatitis
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014