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Experimental: Low Level Laser Therapy for Mucositis

N/A
Waitlist Available
Led By Harold Kim
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from beginning of therapy up to 3 months after completion of therapy
Awards & highlights

Study Summary

The overall purpose of this study is to examine the efficacy of prophylactic low-level laser therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients receiving combined modality therapy consisting of chemotherapy and radiation therapy for head and neck cancer.

Eligible Conditions
  • Mucositis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from beginning of therapy up to 3 months after completion of therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and from beginning of therapy up to 3 months after completion of therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Severe (Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v. 4.0] Grade 3-5 Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy
Number of Participants With Severe World Health Organization [WHO] (Grade 3-4) Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy
Secondary outcome measures
Change in OM-related QOL Assessed Using FACT Questionnaire
Duration of Oral Mucositis
Mean Cumulative Radiation Dose at Time of Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis
+8 more
Other outcome measures
Amount of Narcotic Analgesia Use During Treatment
Number of Participants Who Require Feeding Tube Placement During Treatment (Excluding Patients Who Received a Prophylactic Feeding Tube Prior to the Initiation of Therapy)
Number of Participants With Breaks in Treatment
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: Low Level Laser TherapyExperimental Treatment1 Intervention
Patients meeting the eligibility criteria will be enrolled to receive prophylactic LLLT in addition to standard of care measures for oral mucositis or other toxicity of therapy. The radiation and chemotherapy dose, schedule, modality, technique, and any required adjustments will not be influenced by this protocol and will follow standard existing institutional practices.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Level Laser Therapy
2013
Completed Phase 1
~680

Find a Location

Who is running the clinical trial?

Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,231 Total Patients Enrolled
1 Trials studying Mucositis
38 Patients Enrolled for Mucositis
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,829 Total Patients Enrolled
30 Trials studying Mucositis
1,735 Patients Enrolled for Mucositis
Harold KimPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Low-Level Laser Therapy for Prevention of Oral Mucositis
Harold Kim 2016. "Low-Level Laser Therapy for Prevention of Oral Mucositis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02723604.
~3 spots leftby Apr 2025
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