Low-Level Laser Therapy for Prevention of Oral Mucositis

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• Mucositis 488
• Stomatitis 400

Mucositis

488 studies on the registry are indexed under Mucositis; 70 are open to participants now.

This study's enrollment of 25 is below the median of 50 across 394 interventional studies indexed under Mucositis.

Lead sponsor

Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

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.

  Device: Low Level Laser Therapy

Interventions

• DeviceLow 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 outcomes

1. 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

   Time frame: From beginning of therapy up to 3 months after completion of therapy

2. 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

   Time frame: From beginning of therapy up to 3 months after completion of therapy

Secondary outcomes

1. Change in OM-related QOL Assessed Using FACT Questionnaire

   The QOL assessment taken at the beginning of therapy is subtracted from the QOL assessment taken at the completion of therapy. The QOL scale is the FACT Questionnaire. Measure on a scale of 0 to 4. 0 = not at all and 4= very much.

   Time frame: From beginning of therapy up to completion of therapy

2. Duration of Oral Mucositis

   Survival analysis was used to estimate the duration of oral mucositis. Patients were censored if oral mucositis not resolved by the end of the study.

   Time frame: From beginning of therapy up to 3 months after completion of therapy

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

   Grade of oral mucositis assessed using the NCI CTCAE version 4.0

   Time frame: From beginning of therapy up to 3 months after completion of therapy

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

   Variable is reported on the 1-5 CTCAE scale: 1. - Mild 2. - Moderate 3. - Severe 4. - Life-threatening 5. - Death The maximum recorded severity is reported.

   Time frame: From beginning of therapy up to 3 months after completion of therapy

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

   Variable is reported on the 1-5 CTCAE scale: 1. - Mild 2. - Moderate 3. - Severe 4. - Life-threatening 5. - Death The maximum recorded severity is reported.

   Time frame: From beginning of therapy up to 3 months after completion of therapy

6. Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS)

   Variable is reported on the 1-10 scale Higher values represent a worse outcome The maximum recorded severity is reported

   Time frame: From beginning of therapy up to 3 months after completion of therapy

7. Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0

   Variable is reported on the 1-5 CTCAE scale: 1. - Mild 2. - Moderate 3. - Severe 4. - Life-threatening 5. - Death The maximum recorded severity is reported.

   Time frame: From beginning of therapy up to 3 months after completion of therapy

8. Number of Participants With Trismus Assessed by Measurement of Interincisal Distance

   Trismus is defined as a measurement of interincisal distance less than or equal to 30mm.

   Time frame: From beginning of therapy up to 3 months after completion of therapy

9. Number of Participants With Xerostomia Assessed by CTCAE v. 4.0

   Variable is reported on the 1-5 CTCAE scale: 1. - Mild 2. - Moderate 3. - Severe 4. - Life-threatening 5. - Death The maximum recorded severity is reported.

   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

    The reported dose is at the first incidence of severe oral mucositis.

    Time frame: From beginning of therapy 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

    Survival analysis is used to analyze this endpoint

    Time frame: From beginning of therapy up to 3 months after completion of therapy

Other outcomes

1. Amount of Narcotic Analgesia Use During Treatment

   Time frame: From beginning of therapy up to 3 months after completion of therapy

2. Number of Participants With Breaks in Treatment

   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

   Time frame: Date of completion of chemoradiation therapy

3. Percent Change in Body Weight During the Course of Treatment

   The percent change in body weight was computed by subtracting the baseline weight from the weight after completion of treatment and dividing that quantity by the baseline weight. The confidence interval is estimated using the t distribution.

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

4. Number of Participants 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. Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy

   Time frame: From beginning of therapy up to 3 months after completion of therapy

6. Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by Schedule of Chemotherapy Given Weekly Versus Every 3 Weeks

   Time frame: From beginning of therapy up to 3 months after completion of therapy

7. Time to Reach Planned Dose of Radiation Therapy

   Kaplan-Meier methods are used to estimate time until reaching planned dose.

   Time frame: From the beginning of therapy up to completion of therapy (9 weeks maximum)

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Jul 20, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.