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Efficacy and Safety of CareMin650 for Prevention of Oral Mucositis in HNC Patients Starting Radiotherapy

NCT04699487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-10-10

No results posted yet for this study

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 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.

Conditions

Interventions

DEVICE

Photobiomodulation

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.

Sponsors & Collaborators

  • Monitoring Force Group

    collaborator INDUSTRY

  • NeoMedLight

    lead INDUSTRY

Principal Investigators

  • Michael J Elbe, MD

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2022-03-31
Completion
2022-06-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04699487 on ClinicalTrials.gov