Low Level Laser Therapy in the Treatment of Oral Mucositis on a Paediatric Haemato - Oncology ward

Transcription

1 Low Level Laser Therapy in the Treatment of Oral Mucositis on a Paediatric Haemato - Oncology ward 7 Years of Experience Belgian Pain Society - 14 juni 2014 Véronique Van de Velde Clinical Nurse Specialist Dept. of Paediatric Haemato-oncology, Ghent University Hospital, Ghent, Belgium Rita Cauwels Pediatric Dentist Dept. of Paediatric Densitry & Special Care, PaeCaMed-research, Dental school, Ghent University, Ghent, Belgium 1 CONTENT 1. Introduction: Mucositis and Low Level Laser Therapy 2. Pilot Study and Case Reports in LLLT = Standard of Care on PHO - SCT: 2008 Standardized Guidelines Observation forms Database - Foxpro Training healthcare professionals 4. Registration Study: May 2009 December Randomized Trial 6. Conclusion 2 Introduction Introduction: Painful side effect with few treatment options: - Inflammatory lesions - Common toxicity associated with Chemotherapy Head and neck radiotherapy Hematopoetic stem cell transplantation MUCOSITIS - The result of: A cascade of events involving the entire mucosa Therapy-induced myelosuppression 3 1

2 Complex proces Fase 1: Initiatie Fase 2: Signalering Fase 3: Amplificatie Fase 4: Ulceratie Fase 5: Genezing 4 WHO mucositis scale Graad 0: Geen symptomen MUCOSITIS Definition Graad 1: Erytheem, roodheid Gevoelige mucosa Graad 2: Ulceraties (eventueel erytheem) Pijnlijk, voeding en drank mogelijk Graad 3: Samenvloeiende ulceraties, (eventueel exsudaat) Uiterst pijnlijk, Voeding is onmogelijk, drank is mogelijk Graad 4: Diepe ulceraties, eventueel necrose Extreem pijnlijk, Voeding en drank onmogelijk 5 ORALE MUCOSA 6 2

3 Incidence risk factors Incidence varies depending on: - Chemotherapy regimen - Treatment modality Risk factors can be: - Patient related Age - nutritional status - type of malignacy - pre-existing mouth status - previous episodes of mucositis MUCOSITIS - Treatment related Bolus and continuous infusions - alkylating agents - dose - drugs excreted in saliva conditioning regimen low neutrophilic count 7 MUCOSITIS Incidence - riskfactors Previous mucositis episodes Low weight Poor nutritional status High dose methotrexate (12 gr/m²/day) on d1 and d8 in combination with anthracyclines Low neutrophilic count 8 Prevention Prevention: Multidisciplinary development of a mouth care protocol - Oral assessment - Basic mouth care - Information and guidelines for children and parents MUCOSITIS - Information and education of staff members 9 3

4 Prevention MUCOSITIS Oral assessment: - Dentist: Diagnosis Every 3 months - Physician: - Nurse: Admission When pain occurs During each shift 10 MUCOSITIS Prevention Basic mouth care protocol: - Regular, soft toothbrush or foam toothbrush - Rinsing with Clean water (low risk patients) Chloorhexidine 0,05 % - 0,12 % (high risk patients) - Adaptation of guidelines by age - More extensive mouthcare protocols for Candidiasis and herpes Hematopoetic stem cell transplantation 11 MUCOSITIS Prevention Information and education: - Oral information prior to the start of treatment Children Parents - Written information Parents - Education of staff members 12 4

5 MUCOSITIS Prevention Prevention is not sufficient Prolonged or profound mucositis causes: - Severe pain - Increased need for pain medication - Parenteral nutrition It contributes to: - Rising health care costs - Prolonged hospitalisation 13 MUCOSITIS Prevention Direct influence on the treatment planning - Treatment delay - Dose reduction - Discontinuation of treatment SEARCH FOR Impairment of Quality of Life!!! ADDITIONAL AND NEW TREATMENTS!! 14 LASERTHERAPY Low Level Laser Therapy is recommended by MASCC and the ISOO 2013: the panel recommends that, for centers able to support the necessary technology and training, LLLT be used to attempt to reduce the incidence of OM and its associated pain in patients receiving high dose chemotherapy or chemotherapy before HSCT MASSC: Multinational Association of Supportive Care in Cancer ISOO: International Society for Oral Oncology 15 5

6 Definition LASERTHERAPY Low Level Laser Therapy = a medical technique in which exposure to low level laser light can stimulate or inhibit cellular functions leading to beneficial clinical effect 16 Mechanism LASERTHERAPY Complex, still explored and debated But it s believed that: low level laser radiation is absorbed intra cellulary by photoreceptors in the membrane of the mitochondria 17 Effects - applications LASERTHERAPY Stimulatory effects - Stimulation of β-endorphins and bradykinins - Inhibition of production of prostaglandines and interleukins - Increased cellular activity and angiogenesis Clinical applications Analgesia Anti-inflammatory Woundhealing 18 6

7 Equipment Dio Beam 830 Laser: - AsGaAL diode laser - Wavelenght: 830 nm -Potency: 500 mw LASERTHERAPY Wireless, light and easy to use Visible red guide light 19 LOW LEVEL LASER Mechanism LASERTHERAPY Complex, still explored and debated But it s believed that: low level laser radiation is absorbed intra cellulary by photoreceptors in the membrane of the mitochondria 20 Equipment LASERTHERAPY 5 settings: 1 Joule/cm³ ~ 2 sec ~ preventive 2 Joule/cm³ ~ 4 sec ~ grade 1 4 Joule/cm³ ~ 8 sec ~ grade 2 8 Joule/cm³ ~ 16 sec ~ grade 3 16 Joule/cm³ ~ 32 sec ~ grade 4 The dose or energy released (Joule) is depending on the grade of mucositis Penetration dept in tissues = 3 15 mm 21 7

8 LASERTHERAPY Safety To avoid damaging the eye: - Dense filter glasses - In case of accidental or reflected exposure 22 LASERTHERAPY Procedure 23 LASERTHERAPY Trainning Training of the nurses Theoretical training Practical training Adult Hematology ward: all nurses Pediatric Oncology ward: 7 nurses (ICC = 0.68) 24 8

9 CONTENT 1. Introduction: Mucositis and Low Level Laser Therapy 2. Pilot Study and Case Reports in LLLT = Standard of Care on PHO - SCT: 2008 Standardized Guidelines Observation forms Database - Foxpro Training healthcare professionals 4. Registration Study: May 2009 December Randomized Trial 6. Conclusion PILOT STUDY PILOTSTUDY 2007 Goal: Patients: To assess effectiveness, investigate clinical effects, qualitative outcomes and define treatment frequency 16, aged between 3.4 and 16.8 years Median: 9.1 years Diagnosis: Leukemia and Lymphoma (n = 12) Neuroblastoma (n = 1) Osteosarcoma ( n = 1) Ewing sarcoma (n = 1) Germ cell tumour (n = 1) PILOT STUDY PILOTSTUDY LLLT every 48 hours Registration: Location of oral mucositis Mucositis grade: WHO Released Energy Duration of mucositis episode Pain scores ( VAS / FPS-R) WBC count, nutritional intake, 27 9

10 2. PILOT STUDY PILOTSTUDY LLLT, in addition to standard oral care, causes an immediate analgesic effect 2 to 3 LLLT sessions per mucositis episode seem a realistic approach Improved patient comfort by accelerated healing of the lesions CASE REPORTS Girl 10 years old CASE REPORT Osteosarcoma High dose chemotherapy 29 CASE REPORT DAY 1 Left buccal mucosa: mucositis grade 3 painscale: 7 Left buccal mucosa: mucositis grade 2 painscale: 3 Right buccal mucosa: mucositis grade 3 painscale: 7 No nutrition intake, only liquids Speech: difficult Swallow: difficult Neutrophils: 4840 µl 3! 2! 3! 30 10

11 CASE REPORT DAY 2 Left buccal mucosa: mucositis grade 2 painscale: 2 Left buccal mucosa: mucositis grade 1 painscale: 0 Right buccal mucosa: mucositis grade 2 painscale: 2 Nutrition intake is possible Speech: OK Swallow: OK Neutrophils: 2430 µl 0! 0! 31 CASE REPORT DAY 7 Left buccal mucosa: mucositis grade 1 painscale:0 Right buccal mucosa: mucositis grade 1 painscale: 0 Nutrition intake is possible Speech: OK Swallow: OK Neutrophils: 340 µl CASE REPORTS Easy of use of LLLT High patient acceptance on a pediatric ward LLLT is well tolerated, even when children presented with severe lesions CASE REPORT LLLT is well tolerated, even in small children (help of parents - imaginary story) Positive response of parents No secondary effects 33 11

12 CONTENT 1. Introduction: Mucositis and Low Level Laser Therapy 2. Pilot Study and Case Reports in LLLT = Standard of Care on PHO - SCT: 2008 Standardized Guidelines Observation forms Database - Foxpro Training healthcare professionals 4. Registration Study: May 2009 December Randomized Trial 6. Conclusion LLLT = Standard of Care on PHO - SCT: 2008 Standardized Guidelines Observation forms Database - Foxpro Training healthcare professionals Standardized Guidelines 36 12

13 Concept: EVD observation form 3. Observational forms Name Treatment Date Grade of OM Location and sublocation Painscore Possibility to eat, to speak and swallow Neutrofyl count Trombocyt count Duration of lasertherapy Name of observator Database - Foxpro Database - Foxpro 39 13

14 3. Database - Foxpro Database Foxpro Information Database - Foxpro Treatment of each lesion 42 14

15 3. Training of health care professionals Small group of health care professionals Theoretical education Practical education On the job training Intra Class Correlation (evaluation of 70 mucositis lesions) Training of health care professionals Training of health care professionals 45 15

16 2. Training of health care professionals Training of health care professionals

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18 ICC = 0.65 Fleiss > 0.75 = excellent > 0.40 = middelmatig/goed < 40 = slecht 52 CONTENT 1. Introduction: Mucositis and Low Level Laser Therapy 2. Pilot Study and Case Reports in LLLT = Standard of Care on PHO - SCT: 2008 Standardized Guidelines Observation forms Database - Foxpro Training healthcare professionals 4. Registration Study: May 2009 December Randomized Trial 6. Conclusion 53 REGISTRATION 4. REGISTRATION Period: 22/05/ /12/2012 All patients were treated with chemotherapy and/or radiotherapy This registration includes Hematopoetic Stem Cell Transplant patients Total PHO patients: 415 PHO patients suffering from mucositis: 142 Number of episodes: 343 = from start of mucositis untill complete woundhealing Number of lasersessions: 986 = number of laser interventions Number of lesions treated with LLLT:

19 4. REGISTRATION PHO patients n = 415 Distribution of mucositis Mucositis; 142 REGISTRATION No mucositis; REGISTRATION REGISTRATION 34 % oral mucositis Literature: Incidence in pediatrics? Higher risk of oral mucositis in children 52 % - 80 % in children treated with chemotherapy Up to 90 % < 12 years old Childers et al, 1993, Sonis and Clark,1991, Sonis, Fazio and Fang, 1989, Sonis and Sonis, 1979, Sonis, Sonis and Lieberman, 1978, Fayle and Curzon, REGISTRATION PHO patients n = 415 Mucositis in transplantpatients REGISTRATION 57 19

20 4. REGISTRATION PHO mucositis patients n = 142 Distribution of sex REGISTRATION n Boys 66 Girls REGISTRATION PHO mucositis patients n = 142 Distribution of age REGISTRATION 8 n Age REGISTRATION PHO mucositis patients n = 142 Distribution of diagnoses REGISTRATION

21 4. REGISTRATION PHO mucositis patients n = 142 Number of episodes REGISTRATION E p i s o d e s n Osteosarcoma patients hig risk ALL patients high dose chemotherapy REGISTRATION PHO mucositis patients n = 142 Duration of epsisodes Days Transplantpatiens n 62 Mean pain/patient/episode 4. REGISTRATION Blue = pain before Orange = pain after LLLT REGISTRATION 63 21

22 4. REGISTRATION PHO Laser Sessions n = 986 Duration REGISTRATION 200 n < 5min 5-10 min 6-15 min min min > 30 min REGISTRATION PHO Mucositis Lesions n = 3909 Distribution of location Throat; 255 Mouth; 108 Orofarynx; 27 Uvula; 22 Cheeks; 1000 Palate; 326 Vestibular trough; 336 REGISTRATION Gums; 376 Lips; 661 Tongue; REGISTRATION PHO Mucositis Lesions n = 3909 Distribution of grade of mucositis Grade 4; 113 Missing; 150 Grade 3; 535 Grade 1; 1614 REGISTRATION Grade 2;

23 CONTENT 1. Introduction: Mucositis and Low Level Laser Therapy 2. Pilot Study and Case Reports in LLLT = Standard of Care on PHO - SCT: 2008 Standardized Guidelines Observation forms Database - Foxpro Training healthcare professionals 4. Registration Study: May 2009 December Randomized Trial 6. Conclusion RANDOMIZED TRIAL Low Level Laser Therapy in chemotherapy induced oral mucositis: A comparative study of two therapy regimens Rita Cauwels, Véronique Van de Velde RANDOMIZED TRIAL Started: May 1 st 2011 Inclusion criteria: Chemotherapy induced oral mucositis 4 17 years RANDOMIZED TRIAL RANDOMIZED TRIAL Ongoing study: RegimenA= Standard regimen = LLLT every 48 hours Regimen B= Experimental regimen = LLLT every 24 hours 32 patients included Reasons for low number : Exclusion of patients < 3 years old Occurence of only one episode of mucositis Parental refusal (to come every 24 hours) Exclusion of transplant patients Missings. (during weekends, holidays, ) 69 23

24 6. CONCLUSION Laser therapy can be usefull in oral mucositis and improves the patient s quality of life CONCLUISON Individualized LLLT treatment protocols for special risk groups: SCT, high risk ALL and osteosarcoma patients, Preventive use of LLLT, based on previous reported lesions 70 Thank you for your attention!! Many thanks for: The LLLT - care of all patients: Katia, Leen, Kim, Lieselotte, Sophie and Jaklien, Grietje, Liesbeth, Siham, Inge, Ingrid, Karien, Nathalie, Caro, Jolien Data input: Mieke en Stefanie Database: Dirk en Jo 71 24