MucositisNCT02723604
Low-Level Laser Therapy for Prevention of Oral Mucositis
A study testing Low Level Laser Therapy in people with Mucositis, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 13 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: A Phase II Prospective Trial of Low-Level Laser Therapy for Prevention of Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
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.
Read the 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.
- Conditions
- Mucositis
- Being tested
- Low Level Laser Therapy
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From beginning of therapy up to 3 months after completion of therapy
Secondary outcomes (11)
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.
Measured: From beginning of therapy up to completion of therapy
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.
Measured: 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
Measured: 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:
- - Mild
- - Moderate
- - Severe
- - Life-threatening
- - Death
The maximum recorded severity is reported.
Measured: 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:
- - Mild
- - Moderate
- - Severe
- - Life-threatening
- - Death
The maximum recorded severity is reported.
Measured: 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
Measured: 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:
- - Mild
- - Moderate
- - Severe
- - Life-threatening
- - Death
The maximum recorded severity is reported.
Measured: 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.
Measured: 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:
- - Mild
- - Moderate
- - Severe
- - Life-threatening
- - Death
The maximum recorded severity is reported.
Measured: 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.
Measured: 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
Measured: From beginning of therapy up to 3 months after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion2 Aug 2017
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Harold Kim, Barbara Ann Karmanos Cancer Institute
- Investigators
- Harold Kim, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723604
- Sponsor's protocol ID
- 2015-170
- Other IDs
- NCI-2016-00406, 2015-170, P30CA022453
- Status last verified
- Feb 2023
- First submitted
- 21 Mar 2016
- Last updated
- 27 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective Trial of Low-Level Laser Therapy for Prevention of Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02723604
- Acronym / sponsor ID
- 2015-170
- Conditions
- Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2016
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 27 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Low Level Laser Therapy | Experimental | Device: Low Level Laser TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyPatients 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. | Device | Experimental: Low Level Laser Therapy |
Primary outcome
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
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
11 secondary outcomes
Change in OM-related QOL Assessed Using FACT Questionnaire
Time frame: From beginning of therapy up to completion of therapy
Duration of Oral Mucositis
Time frame: 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
Time frame: From beginning of therapy up to 3 months after completion of therapy
Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0
Time frame: 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
Time frame: 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)
Time frame: From beginning of therapy up to 3 months after completion of therapy
Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0
Time frame: From beginning of therapy up to 3 months after completion of therapy
Number of Participants With Trismus Assessed by Measurement of Interincisal Distance
Time frame: From beginning of therapy up to 3 months after completion of therapy
Number of Participants With Xerostomia Assessed by CTCAE v. 4.0
Time frame: 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
Time frame: 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
Time frame: From beginning of therapy up to 3 months after completion of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold Kim principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Mucositis, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.