ClinicalTrials.gov
ClinicalTrials.gov Menu

Low-Level Laser Therapy for Prevention of Oral Mucositis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02723604
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Harold Kim, Barbara Ann Karmanos Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Mucositis Device: Low Level Laser Therapy Not Applicable

Detailed Description:

A phase II, single-arm trial 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.

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.

Patients will receive LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam will be performed to identify any areas of mucositis. If the patient should develop intraoral lesions they will be targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings to be used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.

Patients will be evaluated prior to therapy, weekly during therapy, two weeks after the completion of therapy, and three months after the completion of therapy. During each assessment, the following toxicities will be assessed: pain, mucositis, dysphagia, xerostomia, dysgeusia, dermatitis, trismus, and quality of life.

Previous studies indicate that approximately 40% of patients will experience severe mucositis with radiation and concurrent chemotherapy. The hypothesis in this trial is that the addition of LLLT to this treatment regimen will decrease the rate of severe acute oral mucositis (OM) to 20%. We plan to enroll 25 patients at our institution in 12 months after the trial opens.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Prospective Trial of Low-Level Laser Therapy for Prevention of Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
Study Start Date : March 2016
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: Experimental: Low Level Laser Therapy
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.
Device: Low Level Laser Therapy
Patients will receive LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam will be performed to identify any areas of mucositis. If the patient should develop intraoral lesions they will be targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings to be used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.




Primary Outcome Measures :
  1. Incidence of severe (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v. 4.0] grade 3-5 or World Health Organization [WHO] grade 3-4) oral mucositis in patients treated to a cumulative radiation dose of at least 5000 cGy [ Time Frame: Up to 3 months after completion of therapy ]

Secondary Outcome Measures :
  1. Change in OM-related QOL assessed using FACT-H&N questionnaire [ Time Frame: Up to 3 months after completion of therapy ]
  2. Duration of oral mucositis [ Time Frame: Up to 3 months after completion of therapy ]
  3. Incidence of any grade oral mucositis in patients treated to a cumulative radiation dose of at least 5000 cGy [ Time Frame: Up to 3 months after completion of therapy ]
  4. Incidence of dysgeusia assessed by CTCAE v. 4.0 [ Time Frame: Up to 3 months after completion of therapy ]
  5. Incidence of dysphagia assessed by CTCAE v. 4.0 and diet assessment [ Time Frame: Up to 3 months after completion of therapy ]
  6. Incidence of pain as assessed by the Visual Analogue Scale (VAS) [ Time Frame: Up to 3 months after completion of therapy ]
  7. Incidence of radiodermatitis assessed by CTCAE v. 4.0 [ Time Frame: Up to 3 months after completion of therapy ]
  8. Incidence of trismus assessed by measurement of interincisal distance [ Time Frame: Up to 3 months after completion of therapy ]
  9. Incidence of xerostomia assessed by CTCAE v. 4.0 [ Time Frame: Up to 3 months after completion of therapy ]
  10. Mean cumulative radiation dose at time of onset of severe (CTCAE v. 4.0 grade 3-4) oral mucositis [ Time Frame: Up to 3 months after completion of therapy ]
  11. Time to onset of severe (CTCAE v. 4.0 grade 3-4) oral mucositis following the initiation of radiotherapy [ Time Frame: Up to 3 months after completion of therapy ]

Other Outcome Measures:
  1. Amount of narcotic analgesia use during treatment [ Time Frame: Up to 3 months after completion of therapy ]
  2. Incidence of breaks in treatment [ Time Frame: Date of completion of chemoradiation therapy ]
    Breaks in treatment defined as one of the following: Missing at least 1 chemotherapy treatment; dose reduction in planned cisplatin administration; OR 3 consecutive days of no radiation therapy secondary to mucositis

  3. Percent change in body weight during the course of treatment [ Time Frame: From date of enrollment until the date of completion of chemoradiation therapy, assessed up to 3 months after completion of therapy ]
  4. Proportion of patients who require feeding tube placement during treatment (excluding patients who received a prophylactic feeding tube prior to the initiation of therapy) [ Time Frame: At the date of completion of chemoradiation therapy ]
  5. Proportion of patients with severe (CTCAE v. 4.0 grade 3-4) oral mucositis by 5000 and 7000 cGy [ Time Frame: Up to 3 months after completion of therapy ]
  6. Proportion of patients with severe (CTCAE v. 4.0 grade 3-4) oral mucositis by schedule of chemotherapy given weekly versus every 3 weeks [ Time Frame: Up to 3 months after completion of therapy ]
  7. Time to reach planned dose of radiation therapy [ Time Frame: Up to 3 months after enrollment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to understand and sign informed consent form approved by the institutional review board (IRB)
  • Males or females greater than or equal to 18 years old
  • Biopsy-proven head and neck cancer (HNC) including cancers of the nasopharynx, oropharynx, larynx, hypopharynx, or HNC of unknown primary origin amenable to therapy with radiation and concurrent chemotherapy
  • Patients who are planned to receive definitive or adjuvant radiotherapy with concurrent platinum-based chemotherapy
  • Patients whose clinical treatment plans include a continuous course of external beam radiotherapy by intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), given as a cumulative dose of 5000 - 7000 centigray (cGy) in single daily fractions of 180 - 200 cGy, combined with a concurrent course of weekly or tri-weekly cisplatin or carboplatin chemotherapy
  • Karnofsky performance status score > 60
  • Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment

Exclusion Criteria:

  • Patient has evidence of current mucositis, mucosal ulceration, or unhealed surgical wounds from surgical resection or biopsy
  • Prior radiation to the head and neck
  • Patients with gross tumor involvement of the oral cavity or oral mucosa
  • Patient planned to receive altered fractionation radiotherapy or multiple fractions per day
  • Patient is using a pre-existing feeding tube for nutritional support at the time of study entry
  • Women who are pregnant or breast-feeding
  • Patient plans to receive concurrent chemotherapy, other than the regimens specified in the inclusion criteria
  • Patients who have chronic immunosuppression or are on current immunosuppressive therapies
  • Patients who have a contraindication to radiation therapy
  • Patients enrolled on another investigational trial for oral mucositis prevention
  • Life expectancy of less than 3 months
  • Unable or unwilling to adhere to study-specified procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723604


Locations
United States, Michigan
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Harold E. Kim    313-576-9543    kimh@karmanos.org   
Principal Investigator: Harold E. Kim, M.D.         
Sub-Investigator: Mark A. Zaki, M.D.         
Sub-Investigator: Pamela Laszewski, R.N.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Harold Kim Barbara Ann Karmanos Cancer Institute

Responsible Party: Harold Kim, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT02723604     History of Changes
Other Study ID Numbers: 2015-170
NCI-2016-00406 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-170 ( Other Identifier: Wayne State University/Karmanos Cancer Institute )
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The same protocol will be opened separately at the University of Pittsburgh Medical Center, where an additional 25 patients will be enrolled. A Data Use Agreement will allow combination of the data for a total of 50 patients to be analyzed.

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