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Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers

ConditionHead and Neck Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Paul Strauss

About this trial

The aim of this feasibility, prospective, single-center trial is to compare an intra-oral Photobiomodulation (PBM) via the Caremin650TM device (NeoMedLight) and a transcutaneous PBM via the ATP 38® device (Swiss Bio Innov) in patients treated with radiotherapy or chemoradiotherapy for cancer of the oropharynx or oral cavity. PBM session will be carried out first at the rate of two sessions per week for preventive purposes, and then, in case of occurence of grade 1 mucositis, three sessions per week with curative purpose.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient (18 years old and older);

Patients with oral cavity or oropharynx cancer treated with radiotherapy or chemo-radiotherapy;

Karnofsky Performance Status > 60%;

Able to understand French;

Disqualifiers

Allergy to polyurethanes;

Head and Neck tumors that are localized to other sites than oral cavity or oropharynx

Previous irradiation of Head and Neck (whatever the time lapse between the two irradiations)

Pregnant and breastfeeding woman;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Photobiomodulation session - intraoral

    Device

    use of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose

  • Photobiomodulation session - transcutaneous

    Device

    use of ATP38® phototherapy device (Swiss Bio Inov Europe) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intraoral PBMOther 1 intervention
Group B: Transcutaneous PBMOther 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative incidence of oral mucositis (grade ≥ 2) in both group (intraoral and transcutaneous PBM)

Oral mucositis will be graded according to NCI-CTCAE V5.0 criteria

Time frame
Until OM resolution, up to 12 weeks

Secondary outcomes

1

Radiotherapy treatment interruption in both group (intraoral and transcutaneous PBM)

Number of cancelled radiotherapy sessions in comparison to initial treatment plan

Time frame
Until OM resolution, up to 12 weeks
2

Duration of oral mucositis in both group (intraoral and transcutaneous PBM)

Number of days

Time frame
Until OM resolution, up to 12 weeks
3

Number of hospitals stays in both group (intraoral and transcutaneous PBM)

Number of unscheduled hospitalizations

Time frame
Until OM resolution, up to 12 weeks
4

Number of introductions of parenteral nutrition in both group (intraoral and transcutaneous PBM)

Number of days from radiotherapy initiation until artificial nutrition introduction

Time frame
Until OM resolution, up to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Paul Strauss

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: