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Low-Level Laser Therapy for Prevention of Oral Mucositis

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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

Tracking Information
First Submitted Date  ICMJE March 21, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date May 23, 2017
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02723604 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
  • Change in OM-related QOL assessed using FACT-H&N questionnaire [ Time Frame: Up to 3 months after completion of therapy ]
  • Duration of oral mucositis [ Time Frame: Up to 3 months after completion of therapy ]
  • 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 ]
  • Incidence of dysgeusia assessed by CTCAE v. 4.0 [ Time Frame: Up to 3 months after completion of therapy ]
  • Incidence of dysphagia assessed by CTCAE v. 4.0 and diet assessment [ Time Frame: Up to 3 months after completion of therapy ]
  • Incidence of pain as assessed by the Visual Analogue Scale (VAS) [ Time Frame: Up to 3 months after completion of therapy ]
  • Incidence of radiodermatitis assessed by CTCAE v. 4.0 [ Time Frame: Up to 3 months after completion of therapy ]
  • Incidence of trismus assessed by measurement of interincisal distance [ Time Frame: Up to 3 months after completion of therapy ]
  • Incidence of xerostomia assessed by CTCAE v. 4.0 [ Time Frame: Up to 3 months after completion of therapy ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: March 24, 2016)
  • Amount of narcotic analgesia use during treatment [ Time Frame: Up to 3 months after completion of therapy ]
  • 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
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Time to reach planned dose of radiation therapy [ Time Frame: Up to 3 months after enrollment ]
Original Other Outcome Measures  ICMJE Same as current
 
Descriptive Information
Brief Title  ICMJE Low-Level Laser Therapy for Prevention of Oral Mucositis
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Mucositis
Intervention  ICMJE 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.
Study Arms 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.
Intervention: Device: Low Level Laser Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2016)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date March 2018
Estimated Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02723604
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Harold Kim, Barbara Ann Karmanos Cancer Institute
Study Sponsor  ICMJE Barbara Ann Karmanos Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Harold Kim Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP