Low-Level Laser Therapy for Prevention of Oral Mucositis

NCT02723604 | Completed Results DMC

• 3 other identifiers: 2015-170NCI-2016-00406P30CA022453
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucositis

Outcome Measures

Primary Outcomes (2)

• 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

  From beginning of therapy up to 3 months after completion of therapy

• 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

  From beginning of therapy up to 3 months after completion of therapy

Secondary Outcomes (11)

• Change in OM-related QOL Assessed Using FACT Questionnaire

  From beginning of therapy up to completion of therapy

• Duration of Oral Mucositis

  From beginning of therapy up to 3 months after completion of therapy

• Number of Participants With Any Grade Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy

  From beginning of therapy up to 3 months after completion of therapy

• Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0

  From beginning of therapy up to 3 months after completion of therapy

• Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment

  From beginning of therapy up to 3 months after completion of therapy

Other Outcomes (7)

• Amount of Narcotic Analgesia Use During Treatment

  From beginning of therapy up to 3 months after completion of therapy

• Number of Participants With Breaks in Treatment

  Date of completion of chemoradiation therapy

• Percent Change in Body Weight During the Course of Treatment

  From date of enrollment until the date of completion of chemoradiation therapy, assessed up to 3 months after completion of therapy

Study Arms (1)

Experimental: Low Level Laser Therapy

EXPERIMENTAL

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

Interventions

Low Level Laser Therapy DEVICE

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.

Experimental: Low Level Laser Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Mucositis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Dr. Harold Kim
• Organization: Barbara Ann Karmanos Cancer Institute

kimh@karmanos.org

313-576-9543

Study Officials

• Harold Kim

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: August 2, 2017
• Study Completion: September 13, 2021
• Last Updated: February 27, 2023
• Results First Posted: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)