Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00406 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2015-170 | Other Identifier | Wayne State University/Karmanos Cancer Institute | |
| P30CA022453 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From beginning of therapy up to completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harold Kim | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | From beginning of therapy up to 3 months after completion of therapy |
|
Adverse event data were collected from the beginning of treatment, up until 3 months after the completion of treatment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harold Kim | Barbara Ann Karmanos Cancer Institute | 313-576-9543 | kimh@karmanos.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2016 | Feb 26, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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 | Grade of oral mucositis assessed using the NCI CTCAE version 4.0 | From beginning of therapy up to 3 months after completion of therapy |
| Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 | Variable is reported on the 1-5 CTCAE scale:
The maximum recorded severity is reported. | 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 | Variable is reported on the 1-5 CTCAE scale:
The maximum recorded severity is reported. | From beginning of therapy up to 3 months after completion of therapy |
| 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 | From beginning of therapy up to 3 months after completion of therapy |
| Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 | Variable is reported on the 1-5 CTCAE scale:
The maximum recorded severity is reported. | From beginning of therapy up to 3 months after completion of therapy |
| 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. | From beginning of therapy up to 3 months after completion of therapy |
| Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 | Variable is reported on the 1-5 CTCAE scale:
The maximum recorded severity is reported. | Up to 3 months after completion of therapy |
| 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. | From beginning of therapy up to 3 months after completion of therapy |
| 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 | From beginning of therapy up to 3 months after completion of therapy |
| Date of completion of chemoradiation therapy |
| 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. | From date of enrollment until the date of completion of chemoradiation therapy, assessed up to 3 months after completion of 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) | 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 | Kaplan-Meier methods are used to estimate time until reaching planned dose. | From the beginning of therapy up to completion of therapy (9 weeks maximum) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 | Posted | Count of Participants | Participants | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| 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. | 5 patients were missing either the beginning and/or completion of therapy QOL data | Posted | Mean | 90% Confidence Interval | units on a scale | From beginning of therapy up to completion of therapy |
|
|
|
| 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. | 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 | Posted | Median | 90% Confidence Interval | weeks | From beginning of therapy up to 3 months after completion of therapy | instances | instances |
|
|
|
| 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 | Posted | Count of Participants | Participants | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| Secondary | Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 | Variable is reported on the 1-5 CTCAE scale:
The maximum recorded severity is reported. | Posted | Number | participants | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| Secondary | Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment | Variable is reported on the 1-5 CTCAE scale:
The maximum recorded severity is reported. | Posted | Count of Participants | Participants | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| 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 | Posted | Count of Participants | Participants | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| Secondary | Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 | Variable is reported on the 1-5 CTCAE scale:
The maximum recorded severity is reported. | Posted | Count of Participants | Participants | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| 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. | Posted | Count of Participants | Participants | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| Secondary | Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 | Variable is reported on the 1-5 CTCAE scale:
The maximum recorded severity is reported. | Posted | Count of Participants | Participants | Up to 3 months after completion of therapy |
|
|
|
| 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. | 15 patients had severe oral mucositis; 3 were missing dose information | Posted | Mean | 90% Confidence Interval | Gray | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| 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 | Posted | Median | 90% Confidence Interval | weeks | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| Other Pre-specified | Amount of Narcotic Analgesia Use During Treatment | Data not collected | Posted | From beginning of therapy up to 3 months after completion of therapy |
|
|
| 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 | Data not collected | Posted | Date of completion of chemoradiation therapy |
|
|
| 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. | Posted | Number | 90% Confidence Interval | percent change in body weight | From date of enrollment until the date of completion of chemoradiation therapy, assessed up to 3 months after completion of therapy |
|
|
|
| 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) | Posted | Count of Participants | Participants | At the date of completion of chemoradiation therapy |
|
|
|
| Other Pre-specified | Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy | Posted | Count of Participants | Participants | From beginning of therapy up to 3 months after completion of therapy |
|
|
|
| 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 | Data not collected | Posted | From beginning of therapy up to 3 months after completion of therapy |
|
|
| Other Pre-specified | Time to Reach Planned Dose of Radiation Therapy | Kaplan-Meier methods are used to estimate time until reaching planned dose. | 1 patient is missing dose information; 5 did not reach planned dose | Posted | Median | Full Range | weeks | From the beginning of therapy up to completion of therapy (9 weeks maximum) |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 23 |
| 23 |
| Xerostomia | General disorders | Systematic Assessment |
|
| Dysgeusia | General disorders | Systematic Assessment |
|
| Trismus | General disorders | Systematic Assessment |
|
| Radiodermatitis | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009057 |
| Stomatognathic Diseases |
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|
| Title | Measurements |
|---|
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
| 9 |
|
| 10 |
|
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|
| Title | Measurements |
|---|---|
|
| Treated with 50-69Gy & did not have OM |
|