Low-Level Laser Therapy for Prevention of Oral Mucositis

NCT02682992 | Completed Results DMC FDA Device

• 1 other identifier: 18-127
• Study Type: interventional
• Target: 47
• 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)

• Percentage of Participants With Severe (WHO Grade 3-4) Oral Mucositis

  Percentage of participants with severe oral mucositis per the World Health Organization (WHO grade 3-4) (ulcerative lesions of the oral mucosa) in patients treated to a cumulative radiation dose of at least 5000 cGy.

  Up to 1 year

• Percentage of Participants With Severe (CTCAE v. 4.0 Grade 3-5) Oral Mucositis

  The Percentage of participants with severe Common Terminology Criteria for Adverse Events (CTCAE, v. 4.0 grade 3-5) oral mucositis in patients treated to a cumulative radiation dose of at least 5000 cGy.

  Up to 1 year

Secondary Outcomes (15)

• Time to Onset of Oral Mucositis

  Up to 1 year

• Mean Cumulative Radiation Dose

  Up to 1 year

• Duration of Oral Mucositis

  Up to 1 year

• Percentage of Participants With Feeding Tube Replacement

  Up to 1 year

• Percentage of Participants With Trismus

  Up to 1 year

Study Arms (1)

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.

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 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.

You may not qualify if:

• 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.
• 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

• David A. Clump, MD, PhD: lead

Study Sites (1)

UPMC Shadyside Department of Radiation Oncology

Pittsburgh, Pennsylvania, 15232, 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: Barbara Stadterman, MPH, Regulatory Specialist Supervisor
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• David A Clump, MD, PhD

  UPMC Department of Radiation Oncology

  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: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 17, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 13, 2022
• Results First Posted: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)