Mucositis
Conditions
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.
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.
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 | From beginning of therapy up to 3 months after completion of therapy | 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. |
| 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 | 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. |
| Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | From beginning of therapy up to 3 months after completion of therapy | Variable is reported on the 1-10 scale Higher values represent a worse outcome The maximum recorded severity is reported |
| Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 | From beginning of therapy up to 3 months after completion of therapy | 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. |
| Number of Participants With Trismus Assessed by Measurement of Interincisal Distance | From beginning of therapy up to 3 months after completion of therapy | Trismus is defined as a measurement of interincisal distance less than or equal to 30mm. |
| Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 | Up to 3 months after completion of therapy | 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. |
| Mean Cumulative Radiation Dose at Time of Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis | From beginning of therapy up to 3 months after completion of therapy | The reported dose is at the first incidence of severe oral mucositis. |
| Time to Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis Following the Initiation of Radiotherapy | From beginning of therapy up to 3 months after completion of therapy | Survival analysis is used to analyze this endpoint |
| Change in OM-related QOL Assessed Using FACT Questionnaire | From beginning of therapy up to completion of therapy | 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. |
| Duration of Oral Mucositis | From beginning of therapy up to 3 months after completion of therapy | 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. |
| 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 | Grade of oral mucositis assessed using the NCI CTCAE version 4.0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Require Feeding Tube Placement During Treatment (Excluding Patients Who Received a Prophylactic Feeding Tube Prior to the Initiation of Therapy) | At the date of completion of chemoradiation therapy | — |
| Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy | From beginning of therapy up to 3 months after completion of therapy | — |
| Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by Schedule of Chemotherapy Given Weekly Versus Every 3 Weeks | From beginning of therapy up to 3 months after completion of therapy | — |
| Time to Reach Planned Dose of Radiation Therapy | From the beginning of therapy up to completion of therapy (9 weeks maximum) | Kaplan-Meier methods are used to estimate time until reaching planned dose. |
| 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 | 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 | From date of enrollment until the date of completion of chemoradiation therapy, assessed up to 3 months after completion of therapy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | ineligible | 1 |
| Overall Study | never received treatment | 1 |
Baseline characteristics
| Characteristic | Experimental: Low Level Laser Therapy |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 23 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Low Level Laser Therapy | 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 | 15 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Low Level Laser 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 | 10 Participants |
Secondary
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
Population: 5 patients were missing either the beginning and/or completion of therapy QOL data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental: Low Level Laser Therapy | Change in OM-related QOL Assessed Using FACT Questionnaire | 2.3 units on a scale |
Secondary
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
Population: 15 of the 23 patients had at least 1 episode of oral mucositis. 2 patients had 2 distinct episodes of oral mucositis. Each instance was analyzed separately
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Low Level Laser Therapy | Duration of Oral Mucositis | 4 weeks |
Secondary
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
Population: 15 patients had severe oral mucositis; 3 were missing dose information
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental: Low Level Laser Therapy | Mean Cumulative Radiation Dose at Time of Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis | 53.5 Gray |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Low Level Laser Therapy | Number of Participants With Any Grade Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy | 23 Participants |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Low Level Laser Therapy | Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 | Grade 1 | 0 participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 | Grade 2 | 23 participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 | Grade 3 | 0 participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 | Grade 4 | 0 participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 | Grade 5 | 0 participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Low Level Laser Therapy | Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment | Grade 1 | 2 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment | Grade 2 | 17 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment | Grade 3 | 4 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment | Grade 4 | 0 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment | Grade 5 | 0 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 1 | 0 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 2 | 0 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 3 | 2 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 4 | 0 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 5 | 5 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 6 | 2 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 7 | 2 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 8 | 5 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 9 | 4 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) | 10 | 3 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Low Level Laser Therapy | Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 | Grade 1 | 5 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 | Grade 2 | 16 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 | Grade 3 | 2 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 | Grade 4 | 0 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 | Grade 5 | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Low Level Laser Therapy | Number of Participants With Trismus Assessed by Measurement of Interincisal Distance | 2 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Low Level Laser Therapy | Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 | Grade 4 | 0 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 | Grade 1 | 2 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 | Grade 2 | 17 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 | Grade 3 | 4 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 | Grade 5 | 0 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Low Level Laser Therapy | Time to Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis Following the Initiation of Radiotherapy | NA weeks |
Other Pre-specified
Amount of Narcotic Analgesia Use During Treatment
Time frame: From beginning of therapy up to 3 months after completion of therapy
Population: Data not collected
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Low Level Laser Therapy | Number of Participants Who Require Feeding Tube Placement During Treatment (Excluding Patients Who Received a Prophylactic Feeding Tube Prior to the Initiation of Therapy) | 7 Participants |
Other Pre-specified
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
Population: Data not collected
Other Pre-specified
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Low Level Laser Therapy | Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy | Treated with 70Gy & had OM | 14 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy | Treated with 70Gy & did not have OM | 6 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy | Treated with 50-69Gy & had OM | 1 Participants |
| Experimental: Low Level Laser Therapy | Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy | Treated with 50-69Gy & did not have OM | 2 Participants |
Other Pre-specified
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
Population: Data not collected
Other Pre-specified
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Low Level Laser Therapy | Percent Change in Body Weight During the Course of Treatment | -10.9 percent change in body weight |
Other Pre-specified
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)
Population: 1 patient is missing dose information; 5 did not reach planned dose
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Low Level Laser Therapy | Time to Reach Planned Dose of Radiation Therapy | 9 weeks |