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Low-Level Laser Therapy for Prevention of Oral Mucositis

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ClinicalTrials.gov Identifier: NCT02682992
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
David A. Clump, MD, PhD, University of Pittsburgh

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 Phase 2

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 OM to 20%. We plan to enroll 50 patients at our institution.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : June 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
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 (WHO grade 3-4) oral mucositis in patients treated to a cumulative radiation dose of at least 5000 cGy [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time to onset of severe (CTCAE v. 4.0 grade 3-4) oral mucositis following the initiation of radiotherapy [ Time Frame: 1 year ]


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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 HRPO.
  • Males or females greater than or equal to 18 years old.
  • Biopsy-proven 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 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 subjects of child-bearing potential must have a negative pregnancy test prior to enrollment.

Exclusion Criteria:

  • Subject 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.
  • Subjects planned to receive altered fractionation radiotherapy or multiple fractions per day
  • Subject is using a pre-existing feeding tube for nutritional support at the time of study entry.
  • Women who are pregnant or breast-feeding.
  • Subject 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): NCT02682992


Contacts
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Contact: Karen Holeva (412) 623-1275 holevakd@upmc.edu

Locations
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United States, Pennsylvania
UPMC Shadyside Department of Radiation Oncology Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Karen Holeva    412-623-1275    holevakd@upmc.edu   
Sub-Investigator: Dwight Heron, MD         
Sub-Investigator: Brian Karlovits, DO         
Sub-Investigator: James Ohr, DO         
Sponsors and Collaborators
David A. Clump, MD, PhD
Investigators
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Principal Investigator: David A Clump, MD, PhD UPMC Department of Radiation Oncology

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Responsible Party: David A. Clump, MD, PhD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02682992     History of Changes
Other Study ID Numbers: LLLT-Mucositis
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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