Head and Neck CancerPrOMiSENCT04699487
Efficacy and Safety of CareMin650 for Prevention of Oral Mucositis in HNC Patients Starting Radiotherapy
A study testing Photobiomodulation in people with Head and Neck Cancer and Oral Mucositis (Ulcerative) Due to Radiation, run by NeoMedLight at 1 site in Germany.
Trial summary
Oral mucositis (OM) can affect up to 90% of head and neck cancer (HNC) patients treated with radiation therapy (RT). The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) recommends the use of photobiomodulation (PBM) in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oral Mucositis (Ulcerative) Due to Radiation, Radiation Therapy Complication
- What is being tested?
- Photobiomodulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 10 May 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
- Histologically proven squamous cell carcinoma of oropharynx, hypo pharynx or oral cavity, with or without prior surgical resection.
- Starting intensity modulated radiation therapy (IMRT) or VoluMetric Arc Therapy (VMAT) on at least 50% of the oral mucosa at a total dose of at least 50 Gy, alone or associated with chemotherapy or targeted therapies.
- Dental examination prior to radiotherapy and any required dental treatment have been performed.
Who cannot join
- Any ongoing malignancy located in head or neck other than primary head and neck cancer (distant metastasis or extension).
- Any active cancer other than primary head and neck cancer.
- Only enteral/parenteral feeding or only liquid food intake are possible.
- Ongoing keratinocyte growth factors (palifermin) use.
- Known polyurethane allergy.
Trial locations and contacts
1 site in 1 country.
Germany1 site
UNIKLINIK RWTH AACHEN - Klinik für Radioonkologie und Strahlentherapie
Aachen, 52074
About this study
Official title: Efficacy and Safety of CareMin650 Used for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer Starting Radiotherapy: the PrOMiSE Study
Oral mucositis (OM) can affect up to 90% of head and neck cancer (HNC) patients treated with radiation therapy (RT). The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) recommends the use of photobiomodulation (PBM) in the prevention of OM.
PBM is the application of lasers or non-coherent light sources such as LEDs, to beneficially influence cellular metabolism.
Read more
Even though PBM has proved its efficacy, this therapeutic option is currently limited by lack of standardization, accuracy and reproducibility. CareMin650 has been developed to overcome these issues, since it allows a reproducible delivery of light, independently of the operator. Additionally, it is easy to use and user-friendly.
PrOMiSE is a prospective, interventional, one-group, open-label, multicentric, international study conducted in European sites, specialized in radio-oncology.
Patients with head and neck cancer (HNC) starting RT and with no oral mucositis (OM) lesion at the time of inclusion, will be eligible. They will be treated by PBM using CareMin650 during the whole period of radiotherapy.
Read the detailed description
Oral mucositis (OM) can affect up to 90% of head and neck cancer (HNC) patients treated with radiation therapy (RT) and/or chemotherapy (CT). It can be as severe as WHO grade 3 / 4 in 35% to more than 50% of cases. The pathobiology of OM relates to injuries that occur in the epithelial and connective tissues, as a response to a complex cascade of biological events, involving all the tissues and cellular elements of the mucosa (Sonis et al., 2004). OM may result in dysphagia, pain, risk of infection, weight loss, interruption or modification of anticancer therapy, or hospitalization.
As OM is a major and frequent side effect of RT, the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) has published clinical practice guidelines for mucositis prevention secondary to cancer therapy. In addition to meticulous oral hygiene, MASCC/ISOO also suggests several therapeutic preventive strategies: growth factors, cytokines, anti-inflammatory agents, natural agents, … In the 2020 guidelines, photobiomodulation (PBM) formerly known as Low-Level Laser Therapy (LLLT), has obtain a full recommendation for the prevention of OM in patients undergoing RT, with or without concomitant CT, for HNC.
PBM is the application of lasers or non-coherent light sources such as LEDs, to beneficially influence cellular metabolism. In a Cochrane review that included 32 clinical trials, PBM was the only treatment that demonstrated a reduction in the risk of severe mucositis. In 2011, a meta-analysis included 11 placebo-controlled randomized trials in 415 patients treated with CT or RT for head and neck cancer (HNC) or hematopoietic stem cell transplantation. According to MASCC/ISOO recommendations, PBM is now recommended to prevent OM in HNC patients receiving RT with or without chemotherapy . The 2014 recommendations have been endorsed by the AFSOS (Association Française pour les Soins de Support en Oncologie) in France. Finally, the National Institute for Health and Care Excellence (NICE) determined that PBM for OM shows no major safety concerns and that evidence on efficacy is adequate in quality and quantity.
Taken together, these data show that PBM is an efficacious and safe option to prevent and/or treat radiotherapy-related OM.
Even though PBM has proved its efficacy, delivery of PBM in OM is currently limited by lack of standardization, accuracy and reproducibility. In particular, the distance between the lighting source and the mucosa or skin is difficult to assess and control accurately. Therefore, the amount of energy delivered may vary from one session to another, as well as from one operator to another.
CareMin650 has been developed to overcome these issues. CareMin650 allows a reproducible delivery of light, independently of the operator. As light is emitted by a flexible surface in contact with the mucosa or the skin, the dose delivered will be controlled. Additionally, it is meant to be easy to use and user-friendly. An interim analysis of SafePBM, a pilot study performed in France provided preliminary data on safety and efficacy. Among 186 CareMin650 sessions performed to prevent (n=152) or treat (n=34) OM in patients with HNC, no treatment-emergent adverse event was considered related to the device and no adverse event led to CareMin650 discontinuation. Only one out of 7 (14%) HNC patients treated in the preventative setting developed OM grade 3. However, this patient had started PBM 6 days after the initiation of RT, instead of starting at day 1 of RT. These encouraging results suggest that CareMin650 is both well tolerated and efficient to prevent severe OM in these high-risk patients.
The aim of the present study is to show the efficacy and safety of the CareMin650 medical device, in the prevention of severe OM in HNC patients receiving radiotherapy. The rate of severe OM will be compared to severe OM rate reported in the literature.
This is a prospective, interventional, one-group, open-label, multicentric, international study that will be conducted in Belgian and German sites, specialized in radio-oncology.
Photobiomodulation will be delivered to all included patients with the CareMin650 (NeoMedLight).
The studied Device CareMin 650 consists in a lightbox and a light applicator that delivers red light at 650nm to the oral mucosa and the neck. The applicator is composed of a connector, a fiberoptic beam of about 1 meter long and a light textile part. Appropriate non-sterile single use disposable sleeves will be added by the operator to cover the part in contact with the patient's mucosa or skin.
This device is CE marked and is used in this study in its intended indication.
No interim analysis is planned.
- Conditions
- Head and Neck Cancer, Oral Mucositis (Ulcerative) Due to Radiation, Radiation Therapy Complication
- Being tested
- Photobiomodulation
- Keywords
- Photobiomodulation, Head and Neck Cancer, Oral Mucositis, Radiation Therapy
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Oral pads will be applied on irradiated areas presenting a risk of radiotherapy-related OM. In addition, a derma pad will be applied on the anterior face of the neck to protect the oropharynx from OM.
The dose to be delivered, at each session and each applied area, has been set at 3 J/cm². In case a lesion appears, the dose will be increased to 6J/cm² for curative treatment.
Treatment with CareMin650 must start on the first day of radiotherapy and will be administered during the whole radiotherapy period, ideally 5 days/week, at least 3 days/week, ideally before the radiotherapy session.
| Study group | Role | What they receive |
|---|---|---|
| Patient receiving Photobiomodulation | Experimental | Not described Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least one OM grade >2 at any time during radiotherapy.
To investigate the efficacy of CareMin650 in the prevention of oral mucositis in patients with HNC starting radiotherapy.
Measured: 5-10 weeks
Secondary outcomes (13)
Frequency of AE classified using MedDRA dictionary
To investigate the safety of CareMin650
Measured: 5-10 weeks
Grading of AE using CTCAE V5
To investigate the safety of CareMin650
Measured: 5-10 weeks
Number of patient with a temporary or sustains discontinuation of PBM due to AE
To investigate the safety of CareMin650
Measured: 5-10 weeks
Time to OM lesions occurrence
To describe the patterns of OM lesions
Measured: 5-10 weeks
Grade (WHO and CTCAE version 3) of OM lesions
To describe the patterns of OM lesions
Measured: 5-10 weeks
Time to OM lesions resolution (defined as lesions that do not require further treatment)
To describe the patterns of OM lesions
Measured: 5-10 weeks
Average duration of WHO grade 3 OM
To describe the duration of the grade 3 OM
Measured: 5-10 weeks
Satisfaction of operators having use the device evaluated by a sponsor semi-quantitative satisfaction questionnaire.
To investigate the handling and the convenience of the device from the operator's perspective
Measured: Through study completion, an average of 1 year
Satisfaction of the patient having use the device evaluated by a sponsor semi-quantitative satisfaction questionnaire.
To investigate the patient satisfaction
Measured: Through patient study completion, an average of 2 months
Percentage of subject with onset of xerostomia during the study
To evaluate the evolution of xerostomia
Measured: 5-10 weeks
Percentage of subject with onset of dysgeusia during the study
To evaluate the evolution of dysgeusia
Measured: 5-10 weeks
Maximum severity of dysphagia as assessed by CTCAE V3
To evaluate the evolution of dysphagia
Measured: 5-10 weeks
Evolution of body weight over time
To evaluate the evolution of body weight
Measured: 5-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start10 May 2021
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoMedLight
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Responsible party
- Sponsor
- Investigators
- Michael J Elbe, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699487
- Sponsor's protocol ID
- NML-20-01
- Acronym
- PrOMiSE
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2020
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.
PubMed 12742264Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
PubMed 32786044Antunes HS, Herchenhorn D, Small IA, Araujo CMM, Viegas CMP, de Assis Ramos G, Dias FL, Ferreira CG. Long-term survival of a randomized phase III trial of head and neck cancer patients receiving concurrent chemoradiation therapy with or without low-level laser therapy (LLLT) to prevent oral mucositis. Oral Oncol. 2017 Aug;71:11-15. doi: 10.1016/j.oraloncology.2017.05.018. Epub 2017 Jun 3.
PubMed 28688677Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7;39(1):210. doi: 10.1186/s13046-020-01715-7.
PubMed 33028357
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CareMin650 Used for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer Starting Radiotherapy: the PrOMiSE Study
- ClinicalTrials.gov ID
- NCT04699487
- Acronym / sponsor ID
- PrOMiSE / NML-20-01
- Conditions
- Head and Neck Cancer, Oral Mucositis (Ulcerative) Due to Radiation, Radiation Therapy Complication
- Keywords
- Photobiomodulation, Head and Neck Cancer, Oral Mucositis, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NeoMedLightIndustry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral mucositis (OM) can affect up to 90% of head and neck cancer (HNC) patients treated with radiation therapy (RT). The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) recommends the use of photobiomodulation (PBM) in the prevention of OM.
PBM is the application of lasers or non-coherent light sources such as LEDs, to beneficially influence cellular metabolism.
Even though PBM has proved its efficacy, this therapeutic option is currently limited by lack of standardization, accuracy and reproducibility. CareMin650 has been developed to overcome these issues, since it allows a reproducible delivery of light, independently of the operator. Additionally, it is easy to use and user-friendly.
PrOMiSE is a prospective, interventional, one-group, open-label, multicentric, international study conducted in European sites, specialized in radio-oncology.
Patients with head and neck cancer (HNC) starting RT and with no oral mucositis (OM) lesion at the time of inclusion, will be eligible. They will be treated by PBM using CareMin650 during the whole period of radiotherapy.
Detailed description
Oral mucositis (OM) can affect up to 90% of head and neck cancer (HNC) patients treated with radiation therapy (RT) and/or chemotherapy (CT). It can be as severe as WHO grade 3 / 4 in 35% to more than 50% of cases. The pathobiology of OM relates to injuries that occur in the epithelial and connective tissues, as a response to a complex cascade of biological events, involving all the tissues and cellular elements of the mucosa (Sonis et al., 2004). OM may result in dysphagia, pain, risk of infection, weight loss, interruption or modification of anticancer therapy, or hospitalization.
As OM is a major and frequent side effect of RT, the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) has published clinical practice guidelines for mucositis prevention secondary to cancer therapy. In addition to meticulous oral hygiene, MASCC/ISOO also suggests several therapeutic preventive strategies: growth factors, cytokines, anti-inflammatory agents, natural agents, … In the 2020 guidelines, photobiomodulation (PBM) formerly known as Low-Level Laser Therapy (LLLT), has obtain a full recommendation for the prevention of OM in patients undergoing RT, with or without concomitant CT, for HNC.
PBM is the application of lasers or non-coherent light sources such as LEDs, to beneficially influence cellular metabolism. In a Cochrane review that included 32 clinical trials, PBM was the only treatment that demonstrated a reduction in the risk of severe mucositis. In 2011, a meta-analysis included 11 placebo-controlled randomized trials in 415 patients treated with CT or RT for head and neck cancer (HNC) or hematopoietic stem cell transplantation. According to MASCC/ISOO recommendations, PBM is now recommended to prevent OM in HNC patients receiving RT with or without chemotherapy . The 2014 recommendations have been endorsed by the AFSOS (Association Française pour les Soins de Support en Oncologie) in France. Finally, the National Institute for Health and Care Excellence (NICE) determined that PBM for OM shows no major safety concerns and that evidence on efficacy is adequate in quality and quantity.
Taken together, these data show that PBM is an efficacious and safe option to prevent and/or treat radiotherapy-related OM.
Even though PBM has proved its efficacy, delivery of PBM in OM is currently limited by lack of standardization, accuracy and reproducibility. In particular, the distance between the lighting source and the mucosa or skin is difficult to assess and control accurately. Therefore, the amount of energy delivered may vary from one session to another, as well as from one operator to another.
CareMin650 has been developed to overcome these issues. CareMin650 allows a reproducible delivery of light, independently of the operator. As light is emitted by a flexible surface in contact with the mucosa or the skin, the dose delivered will be controlled. Additionally, it is meant to be easy to use and user-friendly. An interim analysis of SafePBM, a pilot study performed in France provided preliminary data on safety and efficacy. Among 186 CareMin650 sessions performed to prevent (n=152) or treat (n=34) OM in patients with HNC, no treatment-emergent adverse event was considered related to the device and no adverse event led to CareMin650 discontinuation. Only one out of 7 (14%) HNC patients treated in the preventative setting developed OM grade 3. However, this patient had started PBM 6 days after the initiation of RT, instead of starting at day 1 of RT. These encouraging results suggest that CareMin650 is both well tolerated and efficient to prevent severe OM in these high-risk patients.
The aim of the present study is to show the efficacy and safety of the CareMin650 medical device, in the prevention of severe OM in HNC patients receiving radiotherapy. The rate of severe OM will be compared to severe OM rate reported in the literature.
This is a prospective, interventional, one-group, open-label, multicentric, international study that will be conducted in Belgian and German sites, specialized in radio-oncology.
Photobiomodulation will be delivered to all included patients with the CareMin650 (NeoMedLight).
The studied Device CareMin 650 consists in a lightbox and a light applicator that delivers red light at 650nm to the oral mucosa and the neck. The applicator is composed of a connector, a fiberoptic beam of about 1 meter long and a light textile part. Appropriate non-sterile single use disposable sleeves will be added by the operator to cover the part in contact with the patient's mucosa or skin.
This device is CE marked and is used in this study in its intended indication.
No interim analysis is planned.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient receiving Photobiomodulation | Experimental | Device: Photobiomodulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
- Histologically proven squamous cell carcinoma of oropharynx, hypo pharynx or oral cavity, with or without prior surgical resection.
- Starting intensity modulated radiation therapy (IMRT) or VoluMetric Arc Therapy (VMAT) on at least 50% of the oral mucosa at a total dose of at least 50 Gy, alone or associated with chemotherapy or targeted therapies.
- Dental examination prior to radiotherapy and any required dental treatment have been performed.
Key exclusion criteria (5 listed)
- Any ongoing malignancy located in head or neck other than primary head and neck cancer (distant metastasis or extension).
- Any active cancer other than primary head and neck cancer.
- Only enteral/parenteral feeding or only liquid food intake are possible.
- Ongoing keratinocyte growth factors (palifermin) use.
- Known polyurethane allergy.
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 |
|---|---|---|
| PhotobiomodulationOral pads will be applied on irradiated areas presenting a risk of radiotherapy-related OM. In addition, a derma pad will be applied on the anterior face of the neck to protect the oropharynx from OM. The dose to be delivered, at each session and each applied area, has been set at 3 J/cm². In case a lesion appears, the dose will be increased to 6J/cm² for curative treatment. Treatment with CareMin650 must start on the first day of radiotherapy and will be administered during the whole radiotherapy period, ideally 5 days/week, at least 3 days/week, ideally before the radiotherapy session. | Device | Patient receiving Photobiomodulation |
Primary outcome
Percentage of patients with at least one OM grade >2 at any time during radiotherapy.
Time frame: 5-10 weeks
To investigate the efficacy of CareMin650 in the prevention of oral mucositis in patients with HNC starting radiotherapy.
13 secondary outcomes
Frequency of AE classified using MedDRA dictionary
Time frame: 5-10 weeks
Grading of AE using CTCAE V5
Time frame: 5-10 weeks
Number of patient with a temporary or sustains discontinuation of PBM due to AE
Time frame: 5-10 weeks
Time to OM lesions occurrence
Time frame: 5-10 weeks
Grade (WHO and CTCAE version 3) of OM lesions
Time frame: 5-10 weeks
Time to OM lesions resolution (defined as lesions that do not require further treatment)
Time frame: 5-10 weeks
Average duration of WHO grade 3 OM
Time frame: 5-10 weeks
Satisfaction of operators having use the device evaluated by a sponsor semi-quantitative satisfaction questionnaire.
Time frame: Through study completion, an average of 1 year
Satisfaction of the patient having use the device evaluated by a sponsor semi-quantitative satisfaction questionnaire.
Time frame: Through patient study completion, an average of 2 months
Percentage of subject with onset of xerostomia during the study
Time frame: 5-10 weeks
Percentage of subject with onset of dysgeusia during the study
Time frame: 5-10 weeks
Maximum severity of dysphagia as assessed by CTCAE V3
Time frame: 5-10 weeks
Evolution of body weight over time
Time frame: 5-10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 12742264Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.
- Background: PubMed 32786044Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
- Background: PubMed 28688677Antunes HS, Herchenhorn D, Small IA, Araujo CMM, Viegas CMP, de Assis Ramos G, Dias FL, Ferreira CG. Long-term survival of a randomized phase III trial of head and neck cancer patients receiving concurrent chemoradiation therapy with or without low-level laser therapy (LLLT) to prevent oral mucositis. Oral Oncol. 2017 Aug;71:11-15. doi: 10.1016/j.oraloncology.2017.05.018. Epub 2017 Jun 3.
- Background: PubMed 33028357Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7;39(1):210. doi: 10.1186/s13046-020-01715-7.
- Individual participant dataSharing planned: No
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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.
Michael J Elbe, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Head and Neck Cancer and Oral Mucositis (Ulcerative) Due to Radiation, run by NeoMedLight at 1 site in Germany.
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 4 inclusion and 5 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 10 Oct 2022. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients with at least one OM grade >2 at any time during radiotherapy. (time frame: 5-10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699487, which also lists 4 linked publications.
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 10 Oct 2022.