Divergent Low Level Laser Therapy as novel treatment for oral mucositis in patients with oral or oropharyngeal squamous cell carcinoma’

Rationale: Radiotherapy (RT) is one of the most effective modalities for the treatment of head and neck cancers (HNC). Oral mucositis (OM) is one of the potentially severe side ef-fects of RT. Patients suffering from OM experience pain, swallowing problems, use of anal-gesics, and decreased oral intake. The quality of life is severely decreased and patients are more vulnerable for infections due to OM. Moreover, the (supportive) care for patients with OM has a considerable economic impact. Currently at the University Medical Center (UMC) Utrecht, the therapy for OM has a supportive character and consists of analgesics for pain management, mouth rinses and good oral hygiene for reducing infectious risk, and nutritional support for the decreased oral intake. Low Level Laser Therapy (LLLT) might be the most feasible in patients with HNC and thus is subject of this study. At present time, however, LLLT requires expensive equipment and specialized training. Current LLLT is spot-focused and thus named convergent Low Level Laser Technology. One lesion in the oral cavity can be treated at a time during a few seconds. Though, we have the availability to use a laser device, the Mellinn650, which is not expensive, can be applied by the patient and does not require much training. This is because it uses divergent Low Level Laser Technology (dLLLT), which does not work specifically on one spot in the oral cavity, as with classic LLLT devices, but will treat the complete oral cavity at the same time with the use of two clips emitting laser light simultaneously.
Objective: The main aim of this study is to get insight in the effectiveness of dLLLT added to usual care (UC) compared to UC in patients with oral or oropharyngeal squamous cell carcinoma (O/OPSCC) during RT on the severity of OM. The second aim of this study is to get insight in the effectiveness of dLLLT added to UC compared to UC in patients with O/OPSCC during RT in the number of days with OM, the number of oral infections, pain, xerostomia (dry mouth), maximum mouth opening, taste, and quality of life. The third aim of this study is to get insight in the perception of patients with O/OPSCC related to dLLLT added to UC and UC only.
Study design: This study is a randomised clinical trial and will take place at UMC Utrecht . In total 70 patients will be included; 35 will get UC and dLLLT (intervention group) and 35 will get UC (control group).
Study population: All patients with primary O/OPSCC scheduled for RT at UMC Utrecht.
Intervention: The Mellinn650 is a semiconductor laser treatment instrument, capable of providing dLLLT. The light spots are situated in the 2 disposable mouth clips and emit laser light with a wavelength of 650 nanometers (nm) and an adjustable output power of 1-5 milli-watts (mW) in both clips (total maximum power of 10 mW). The Mellinn650 is not spot-focussed, thus irradiating the entire interior of the mouth, the so-called divergent Low Level Laser Therapy (dLLLT). The time of therapy is 2 times per day 30 minutes and will be used during the RT period of 7 to 8 weeks.
Main study parameters/endpoints: The severity of OM will be measured by the WHO-criteria and National Cancer Institute’s Common Toxicity Criteria (NCI-CTC).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The measurement sessions at week 1, 4, 8, and at 6 months will take maximally 40 minutes. The measurement sessions at week 2, 3, 5, 6, 7 will take 10 minutes.
The burden is in our opinion minimal. There are no specific advantages or risks for the subjects in this study, because the physical burden is minimal and so the consequences for the subjects are nihil.

The use of dLLLT will lower the severity of mucositis in patients with oral or oropharyngeal squamous cell carcinoma during radiotherapy

Week 0 (M0), 2 (M2), 3 (M3), 4 (m4), 5 (M5), 6 (M6), 7 (M7), 8 (M8), and at 6 months (M9).

Divergent low level laser therapy