PREVENTION & TREATMENT OF ORAL MUCOSITIS INFORMATION FOR SPECIALISTS
TABLE OF CONTENTS INTRODUCTION 3 INTRODUCTION 5 ABOUT ORAL MUCOSITIS 6 ABOUT THE MELLINN650 DEVICE 8 HOW THE MELLINN650 WORKS 9 EVIDENCE & EXPERIENCES For cancer patients, oral mucositis, or OM, is an extremely unpleasant, but very common side-effect of chemotherapy or radiotherapy. Its effects include severe pain, loss of weight and even disruption of chemotherapy or radiotherapy treatments. Using the provides pain relief, helps dissolve mucus and accelerates recovery. The mellinn technology is based on the capability of laser beams to cure damaged tissue at cell level (via biostimulation ). In this brochure we would like to tell you about this special medical equipment and the results being obtained with cancer patients in the Netherlands. 10 USING THE MELLINN650 12 ABOUT MELLINN 12 CONTACT 2 3
ABOUT ORAL MUCOSITIS As cancer survival rates rise, quality of life, fortunately, is becoming more prominent in our treatment plans. The treatment of side effects like mucositis should definitely be part of this. Dr. Wim Tissing, paediatric oncologist at the UMCG and a member of the Mucositis Working Group of the MASCC Discomfort and risks you want to spare your patients As a medical specialist or nurse, you are no doubt acutely aware of the serious effects of oral mucositis. Patients may experience severe pain, viscous saliva in their mouths and throats, and may be especially susceptible to bacteria. Halitosis caused by inflammations leads to embarrassment and social discomfort. Pain felt during eating and drinking may cause weight loss and diminished resistance, leading to extended hospitalisation or even temporary interruption of chemotherapy or radiotherapy treatments. In nearly all cases, oral mucositis causes serious discomfort and reduced quality of life. A side effect, but no triviality Research shows that 40 to 100% of all cancer patients suffer from oral mucositis at some point: Close to 75% of patients with cancer of the head or neck who receive radiotherapy Close to 60% of patients who receive radiotherapy or chemotherapy Oral mucositis may be a mere side effect of a far more serious illness, cancer, but this does not make it a trivial matter. Incidental healthcare costs involved in oral mucositis are substantial. They can include extended hospitalisation, treatment at the intensive care unit, tube feeding, analgesics, interruption of treatment, and additional medical care. 4 5
ABOUT THE MELLINN650 DEVICE The deserves the increasing attention it is getting Until recently, complete prevention or cure of oral mucositis was considered almost impossible. A variety of treatments from saline solutions to special tinctures were used to fight this nasty side effect of chemotherapy and radiotherapy, with varying results. The first experiences with the device in the Netherlands have demonstrated that this innovative application deserves the attention it is now starting to receive from the scientific world as well as in the treatment of patients. Radiation with a hand-held laser system The technology is based on the capability of laser beams to cure damaged tissue at cell level (via biostimulation ). This is done by treating the inflamed mucous membrane with a hand-held laser system, the, with a wavelength of 650 nm. This almost immediately results in pain relief, while existing inflammations heal more quickly. Safe, easy and effective The is an approved Class II medical tool. It is a conveniently sized system that applies the existing technology of low-level laser therapy (LLLT) in an innovative way as a means for the prevention or treatment of oral mucositis. Safe, easy and effective. The operates on the proven interaction between laser beams and cell tissue. Using the, the patient s mucous membrane is radiated with laser beams at a wavelength of 650nm. Treating oral mucositis with laser therapy can have the following effects: Prevention of oral mucositis Pain relief (less severe and over a shorter period) Dissolving of mucus Anti-inflammatory Healing Preventive use delivers the best results As a preventive measure, the is best used from the start of chemotherapy or radiotherapy treatments, until two weeks after the last treatment. This approach will reduce the adverse effects of oral mucositis on patients to the minimum. 6 7
HOW THE MELLINN650 WORKS EVIDENCE & EXPERIENCES The operates on photochemical interaction. In the same way as photosynthesis draws energy from sunlight to convert carbon dioxide into carbohydrates, this process absorbs the low-level laser beams intracellularly by way of chromophores (photoreceptors) in the membrane of the mitochondria. Stimulating effects of the treatment Proliferation of macrophages, lymphocytes, fibroblasts, Painless, non-invasive and without side effects Analgetic Affecting the pain threshold by stimulating ß-endorphine and bradykinines Anti-inflammatory Inhibition in the production of prostaglandins and interleukins Wound healing Accelerated tissue regeneration by increased cellular activity and angiogenes Clinical trial at UMCG Currently, a randomized double-blind clinical study is being performed as to the impact of the treatment at University Medical Center Groningen (UMCG) in the Netherlands. Says paediatric oncologist and initiator Dr. Wim Tissing: Based on existing literature on low-level laser therapy (LLLT) the technology used by the and on early results with the, my expectations of this research are high. Because of the fact that use of the The independent Cochrane Collaboration, a worldwide organisation advocating evidence-based medicine (EBM), found that a test conducted in 2010 provided sufficient cause to recommend the treatment method (Cochrane Database Syst Rev, 2010 Aug 4;(8):CD001973). In this test, three different treatments were applied to approximately 1,500 patients. Lowlevel laser treatment was the only treatment that showed a reduction of very severe mucositis. endothelial cells, keratinocytes ATP synthesis Release of growth factors and other cytokines Collagen synthesis Reducing effect of ROS; prevents apoptosis of epithelial and sub-mucosal cells attacked by chemotherapy or radiation therapy (based on a physiopathological model) Nucleus Laser light wavelength 650nm Epidermis/skin Mitochondrion (energy plant) Chromophores/ photoreception is relatively new in the Netherlands, the clinical trial at UMCG is an important step towards establishing this method as a leading and reliable means for the prevention and treatment of oral mucositis. LLLT recommended by Cochrane The technology the is based on low-level laser therapy or LLLT has been the subject of several international scientific research projects. LLLT recommended by the MASCC The Multinational Association of Supportive Care in Cancer (MASCC) has also stated that the use of LLLT is recommended for the prevention of oral mucositis and the accompanying pain in patients receiving high doses of chemotherapy or radiotherapy. The panel that conducted the research said they felt encouraged by the accumulating evidence. 8 9
USING THE MELLINN650 The relief was evident Preventive use at home Benefits of use at home Added value of the The is already being widely used. The Sophia The can, of course, be operated by medical staff. Encouraging use at home will save time for your medical staff. Here s a brief overview of the key features and advantages of Children s Hospital in Rotterdam had one of the first positive But the easy and safe technology the treatment is based on It will also help reduce hospitalisation time of patients with oral the : experiences. The effects on the mucositis patient we treated makes this conveniently sized equipment also highly suitable for mucositis (about one in five OM patients is hospitalised) as well with the are encouraging, says paediatric home use by patients. The best results are achieved when the as reducing the need for tube feeding and morphine use, thus Prevention & treatment of oral mucositis oncologist, Dr. Martine van Grotel. We saw less pain and is used from the start of chemotherapy or radiothe- leading to lower healthcare costs. The also gives Technology recommended by Cochrane and MASCC less mucus, resulting in less discomfort during eating and rapy until a couple of weeks after the final treatment. We recom- patients more control over the quality of their life. Saves healthcare costs drinking. The treatment provided evident relief. The young mend you discuss this treatment with your patient as soon as Improves quality of life for and treatability of cancer patients patient treated by Van Grotel with the was also he or she qualifies for chemotherapy or radiotherapy. Quick result: less pain and less mucus, fewer inflammations, enthusiastic. Every time he looked forward to being able to less decrease in resistance use the laser clips again; they provided real relief. The pain Reduced chance of additional hospitalisation and discomfort caused by mucositis can be very severe. Reduced chance of interruption in chemotherapy or radiotherapy Oral mucositis as a side effect of chemotherapy can be severe. This technology could make the side effects more bearable. Safe, easy to use and effective Suitable for use at home Dr. Martine van Grotel, paediatric oncologist, Sophia Children s Hospital, Rotterdam 10 11
ABOUT MELLINN The was developed by mellinn bv, a medical technology company based in Delden, the Netherlands with a focus on patient-oriented innovation. Thankfully, we are not alone in the battle against oral mucositis. We collaborate with parties such as the University Medical Center Groningen, Erasmus MC-Sophia, and the University of Twente in the Netherlands. Please visit our website for more information and news, documentation, medical backgrounds and experiences of patients and medical staff. You may also contact us directly through the contact data below. mellinn bv Langestraat 80 7491 AJ Delden The Netherlands + 31 (0)74 267 26 32 info@mellinn.com mellinn.com