NCT01307540

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
Last Updated

March 3, 2011

Status Verified

June 1, 2010

Enrollment Period

2.8 years

First QC Date

March 1, 2011

Last Update Submit

March 1, 2011

Conditions

Oral Mucosal UlcerationOral MucositisOral Lesion

Study Arms (2)

Active light therapy

EXPERIMENTAL

oral mucosa is exposed to a light source (broad band of wavelengths, 400-800 nm)

Device: phototherapy

Inactive light therapy

PLACEBO COMPARATOR

Oral mucosa is exposed to a extremely low-intensity light which is assumed to have no effect.

Device: phototherapy

Interventions

phototherapyDEVICE

low level light therapy, broad band light wavelengths.

Also known as: QRay1
Active light therapyInactive light therapy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Oral UlcerStomatitis

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 3, 2011

Study Start

February 1, 2007

Primary Completion

December 1, 2009

Last Updated

March 3, 2011

Record last verified: 2010-06