StrataXRT® for the management of radiation induced skin reactions Radiation Dermatitis – The Unwelcome Consequence of a Life-Saving Therapy
Radiation dermatitis is an acute skin reaction affecting approximately 95% of patients who receive radiation therapy to the breast, groins or perineum.1,2,3 It generally ranges from erythema to dry or even moist desquamation and can be a source of significant pain, discomfort and psychological distress. In particular, moist desquamation poses the risk of infection and can result in treatment breaks which impair patient outcomes.3
· Up to 50–60% of patients receiving cancer · The introduction of modern mega-voltage treatment treatment will undergo radiation therapy machines with skin-sparing capabilities have at some stage of their illness.1,4,5 improved but not eliminated skin toxicities.6
How do the current therapies rate? Studies assessing lotions, creams, or emulsions (aloe vera, hyaluronic acid, corticosteroids, sucralfate) either showed no benefit in managing radiation dermatitis or provided conflicting evidence.7,8,9 It is essential that any skin damage is minimized by ensuring that interventions are based upon best practice, and supported by evidence-based guidelines.2
Consensus goals of care for skin reactions during radiation therapy8, 10, 11 StrataXRT scores
Initial maintenance of skin integrity
Reduced potential of further exacerbation of skin reactions
Minimized water loss and optimized skin hydration by means of topical agents
Promotion of comfort and compliance
Reduction of pain and pruritus without causing a bolus effect
Control of bleeding, odor and excessive exudate (in combination with secondary dressing)
Provides ideal environment for rapid healing and re-epithelialization
Promotion of moist wound healing environment where skin is broken
Protection from trauma & friction
Protection of infection
2 Web www.CivcoRT.com Email [email protected] The RTOG Scale for Radiation Dermatitis
The RTOG scale (Radiation Therapy Oncology Group) provides a standardized description of radiation induced side effects. Interventions are usually matched to the skin’s reaction based on its assessment and the RTOG score.
RTOG Observation: Observation: Scale Score External Signs Cellular Level Clinical Assessment Treatment Goals
Maintain soft, supple, clean, No visible change to skin 0 odor free and intact skin.
Maintain soft, supple, clean Redness. Inflammation odor free, intact skin, reduce 1 Mild tightness/itch irritation and promote comfort.
Promote skin hydration, Sensitive skin with bright redness comfort and maintain skin With/without dry desquamation 2 integrity. Reduce itch, pain, Tightness/itch/sore soreness and discomfort.
Reduce risk of complications Photos from several patients. Patchy moist desquamation of further trauma and Other scales of measurement 2.5 Moderate oozing infection. Reduce pain, include RISRAS and CTCAE. The key soreness and discomfort.13 measurement point on this RTOG scale is level 2.5 (2b), which denotes the first level of the appearance of Reduce the risk of moist desqumation. Confluent moist desquamation infection, minimize pain 3 Pitting oozing Images (RTOG 0–3) courtesy of and trauma of the skin. The Princess Royal Radiotherapy Review Team, St James’s Institute of Oncology, The Leeds Teaching Debride the wound. Control Hospitals NHS Trust. Taken from the associated bleeding and 4 Ulceration, bleeding, necrosis publication “Managing Radiotherapy oozing (exudate), minimize Induced Skin Reactions, a Toolkit for effects of wound infection. Healthcare Professionals”.
Progression of symptoms and skin changes according to the RTOG scale during radiation therapy*
* Curve generated from the general progression of radiation dermatitis for patients undergoing radiation therapy. Levels of reaction differ significantly between patients and treatments. If untreated however the level of reaction generally follow the shape of this curve.4
Web www.CivcoRT.com Email [email protected] Global Sales 800.842.8688 | +1 712.737.8688 3 Why is StrataXRT an Innovative Wound Dressing?
StrataXRT film-forming gel dries as a thin, flexible and protective layer that is gas permeable, waterproof, inert and has no measurable pH value.
Can be applied Faster re-epitheliali Does not cause Lightly bonds from day one of zation12 promoted bolus effect14 to the most radiation therapy by a moist superficial wound healing damaged layer environment of the skin
Sterile, biologically Fast drying For best resut, Full contact inert and leave in constant flexible wound bacteriostatic contact with dressing the skin
Management of Radiation Dermatitis with StrataXRT
StrataXRT helps to reduce Trans Epidermal Water Loss (TEWL) while promoting a moist Application wound healing environment, leading to: of StrataXRT · Faster re-epithelialization12 of the skin post- therapy · Relief of low grade cutaneous changes such as dry, itching, flaking, peeling and irritated skin Stratum corneum · Reduced pain, redness and heat, while helping to soothe exposed areas in more severe inflammatory changes Immature cell StrataXRT protects the fragile epidermis Dead cell during dry desquamation leading to: · Preservation of the skin integrity · Prevention of excessive sloughing of the outmost layers Irradiated site StrataXRT protects the dermal stroma from long-term deterioration during moist desquamation leading to: · Optimization of the environment for the reparative process · Reducing the risk of infection
4 Web www.CivcoRT.com Email [email protected] Measurement of Clinical Signs and Symptoms During Radiation Therapy Treatment
0 0 Cumulative radiation dose 5 irst day of radiation therapy
0 Number of Grays 0 50 Application of StrataXRT 2 5 0 Pain 2 0 0 Measurement of Clinical Signs and Symptoms During Radiation Therapy Treatment 1 5 Itching 20 Evaluation scale Evaluation 1 0 Burning sensation 0 0 Cumulative radiation dose 0 5 10 5 irst day of radiation therapy Erythema
0 Number of Grays 0 0 0 0 50 Application of StrataXRTDay 1 5 11 1 15 1 1 21 2 25 2 2 1 5 Hydration 2 5 0 Pain 2 0 0 During the application period, StrataXRT showed a decrease of pain by 20 8 *, of the itching by 22 22 *, of the burning 1 5 Itching 20 sensation by 2 *, the erythema by 21 1 * and an improvement of the hydration by 2 * *p-value 0 05 Evaluation scale Evaluation 1 0 Burning sensation 0 5 10 Erythema 0 0 0 Day 1 5 11 1 15 1 1 21 2 25 2 2 1 5 HydrationEvolution of Risras Score During Radiation Therapy Treatment and When pplying StrataXRT During the application period, StrataXRT showed a decrease of pain by 20 8 *, of the itching by 22 22 *, of the burning REDUCTION O 1 85 Cumulative radiation dose sensation by 2 *, the erythema by 21 1 * and an improvement of the hydration by 2 * *p-value 0 05 1 1 1 0 0 Number of Grays RISRAS score Radiation-induced 15 0 55 Skin Reactions Evolution of Risras Score During Radiation Therapy Treatment and When pplying StrataXRT Assessment Scale 1 0 1 50 REDUCTION O 1 85 Cumulative radiation dose 1 1 1 0 5 Number of Grays
1 0 0 RISRAS score scale Evaluation Radiation-induced12 0 0 15 0 55 Skin Reactions Day 0 1 2 5 8 0 Assessment Scale 1 0 Clinical Study 1 50 1 0 5 Evaluation scale Evaluation 12 0 0 Day 0 1 2 5 8 0 A 28-patient multicenter study performed in Spain (2015). Starting of therapy: Impact RTOG on scoreRadiation of 2.5 eam ± 0.5. 1 0 0 13 All patients were treated with StrataXRT while undergoing radiation therapy. StrataXRT Thermoplastic reduces the severity of 0 8 radiation induced skin reactions and significantly decreases the RISRAS score, evenMask if patients are undergoing 0 Impact on Radiation eamradiation therapy treatment.1 0 0 0 0 5 Thermoplastic 0 8
TMR alue 0 Mask 0 0 0 Topical Product Measurement of Clinical Signs and Symptoms During Radiation Therapy Treatment 0 2 0 5 with Silicone 0 1
TMR alue 0 0 0 Cumulative radiation dose 0 0 0 5 irst day of radiation therapy 0 1 2 5 8 10 11 12 Topical Product 0 2 0 Number of Grays 0 with Silicone 0 1 50 Application of StrataXRT Depth in White Water mm 2 5 0 0 0 Pain 2 0 Phantom physical dressing M beam 0 1 2 5 8 10 11 12 0 1 5 Itching 0 5mm Phantom 18 M beam Depth in White Water mm 20 Evaluation scale Evaluation 1 0 Burning sensation 0 5 10 Phantom physical dressing M beam Erythema 0 5mm 0 0 Phantom 18 M beam 0 Day 1 5 11 1 15 1 1 21 2 25 2 2 1 5 Hydration
During the application period, StrataXRT showed a decrease of pain by 20 8 *, of the itching by 22 22 *, of the burning sensation by 2 *, the erythema by 21 1 * and an improvement of the hydration by 2 * *p-value 0 05
Evolution of Risras Score During Radiation Therapy Treatment and When pplying StrataXRT
REDUCTION O 1 85 Cumulative radiation dose 1 1 1 0 0 Number of Grays RISRAS score S incare Overall Radiation-induced Costs During Radiation Therapy Treatment 15 0 55 Skin Reactions S incare Overall Costs During Radiation Therapy Treatment Assessment Scale 1 0 1 50 Cost Extra nursing time needed to cut Nursing 1 0 Cost and 5 adapt dressings StrataXRT Evaluation scale Evaluation time Extra nursing time needed to cut Nursing and adapt dressings 12 0 time StrataXRT 0 No nursing time Day 0 1 2 5 8 0 Need to be carefully applied and No nursing time Physical Need to be carefully applied and Physical ad usted to avoid bolus effect dressings Self-applica le y patient ad usted to avoid bolus effect dressings Self-applica le y patient Not developed for Burn Developed for Not developed for Impact onBurn Radiation eam 1 0 Developed for cream radiation dermatitis cream radiation dermatitis radiation dermatitis 0 radiation dermatitis Moisturi ing StrataXRT StrataXRTThermoplastic DoesStrataXRT Not Cause0 8 Bolus Effect Proven clinical efficacy Moisturi ing Proven clinical efficacy cream creamMask 0 No proven clinical efficacy No proven clinical efficacy 0 Common treatments StrataXRT 0 5 Common treatments StrataXRT
The Springfield Radiation Oncology Center in TMR alue Australia0 conducted measurements on increasing 0 14 electron beam energy Topicallevels Productto verify the bolus effect0 2 of a clinical dose of StrataXRT. This study showed that StrataXRT does notwith cause Silicone a bolus effect since0 1 the energy of the beam is not affected by the product. 0 0 0 1 2 5 8 10 11 12 Depth in White Water mm Measurements at Different Energy Levels Measurements at Different Energy Levels with and without StrataXRT pplication Phantom physical dressing M beam 0 5mm Electron BeamPhantom with18 M and beam without StrataXRT pplication Method 12 1 Me Electron Beam -0 1 12 1 Me 1 -0 1 Figure 1 shows the 0 cm -0 1 0 experimental setup of the 1 -0 1 12 100 0 cm 0 100 10 dosimetric measurement. SSD 12
8 Three readings were made 10 SSD 10 10cm for each of the energy ield Si e 8 levels (6, 9, 12, 16 MeV). StrataXRT 10 10cm Solid Water ield Si e Nanocloulombs The first time without the Roos Chamber StrataXRT 2 Solid Water application of StrataXRT, Nanocloulombs 0 Roos Chamber Me Me 12the Me second1 Me S incare time with Overall the Costs During Radiation Therapy Treatment 2 application of StrataXRT. Figure 1 Cost 0 with StrataXRT without StrataXRTExtra nursing time needed to cut Nursing Me Me 12 Me 1 Me and adapt dressings time StrataXRT No nursingwith time StrataXRT without StrataXRT Need to be carefully applied and Physical ad usted to avoid bolus effect dressings Self-applica le y patient Web www.CivcoRT.com Email [email protected] Global Sales 800.842.8688 | +1 712.737.8688 5 Not developed for Burn Developed for cream radiation dermatitis radiation dermatitis Moisturi ing StrataXRT cream Proven clinical efficacy No proven clinical efficacy Common treatments StrataXRT
Measurements at Different Energy Levels with and without StrataXRT pplication Electron Beam 12 1 Me -0 1 1 -0 1 0 cm 0 12 100
10 SSD 8 10 10cm ield Si e StrataXRT Solid Water Nanocloulombs Roos Chamber 2 0 Me Me 12 Me 1 Me
with StrataXRT without StrataXRT Radiation Dermatitis Case Studies: All patients continued radiation therapy while applying StrataXRT
Case Study Korea, 2015 Yonsei University Health System, Severance Hospital, Korea
A series of case studies was performed for treatment of radiation dermatitis at different RTOG stages of toxicity. Patients and nurses reported an overall improvement, reduced itching and pain symptoms. Patients positively evaluated the transparency of StrataXRT once it dried, while protecting the affected area.15
Head and Neck Cancer
Patient showing a RTOG 3 radiation dermatitis Patient applied StrataXRT during ongoing with moderate edema and a confluent moist radiation therapy. After 7 days of topical desquamation. treatment, the moist desquamation and edema resolved and the skin pigmentation improved.
Patient showing a severe RTOG 2.5 radiation Patient applied StrataXRT during ongoing radiation dermatitis with a marked edema with superficial therapy. After 3 days of topical treatment there is ulceration and a confluent moist desquamation. no longer a sign of patchy moist desquamation. Patient shows a decrease of the edema but still a persisting depigmentation of the skin.
6 Web www.CivcoRT.com Email [email protected] Radiation Dermatitis Case Studies: All patients continued radiation therapy while applying StrataXRT
Case Study Spain, 2015 Hospital Universitario de Fuenlabrada, Hospital Ruber Internacional, Madrid Spain
A series of case studies was performed on patients with a RTOG score of 2.5 ± 0.5. Patients and nurses reported an overall improvement, reduced itching and pain symptoms. Patients appreciated the ease of use as well as the comfort provided by StrataXRT.16
Hospital Universitario Head and neck cancer de Fuenlabrada Comunidad de Madrid
Patient showing a RTOG 3 radiation dermatitis Patient applied StrataXRT during ongoing with moderate edema and a confluent moist radiation therapy. After 19 days of topical desquamation. treatment, a reduction of edema and erythema, and closure of the wound was observed.
Calf muscle cancer
Patient showing a severe RTOG 2 radiation Patient applied StrataXRT during ongoing radiation dermatitis with a bright erythema and an therapy. After 20 days of topical treatment there is no inflammation of the scar. No signs of dry longer a sign of the erythema. The scar shows low desquamation. inflammatory signs, while the surrounding skin area has persisting depigmentation.
Web www.CivcoRT.com Email [email protected] Global Sales 800.842.8688 | +1 712.737.8688 7 Measurement of Clinical Signs and Symptoms During Radiation Therapy Treatment
0 0 Cumulative radiation dose 5 irst day of radiation therapy
0 Number of Grays 0 50 Application of StrataXRT 2 5 0 Pain 2 0 0 1 5 Itching 20 Evaluation scale Evaluation 1 0 Burning sensation 0 5 10 Erythema 0 0 0 Day 1 5 11 1 15 1 1 21 2 25 2 2 1 5 Hydration
During the application period, StrataXRT showed a decrease of pain by 20 8 *, of the itching by 22 22 *, of the burning sensation by 2 *, the erythema by 21 1 * and an improvement of the hydration by 2 * *p-value 0 05
Evolution of Risras Score During Radiation Therapy Treatment and When pplying StrataXRT
REDUCTION O 1 85 Cumulative radiation dose 1 1 1 0 0 Number of Grays RISRAS score Radiation-induced 15 0 55 Skin Reactions Assessment Scale 1 0 1 50 1 0 5 Evaluation scale Evaluation 12 0 0 Day 0 1 2 5 8 0
Impact on Radiation eam 1 0 0 Thermoplastic 0 8 Mask 0 0 0 5
TMR alue 0 0 Topical Product 0 2 with Silicone 0 1 0 0 0 1 2 5 8 10 11 12 Depth in White Water mm
Phantom physical dressing M beam 0 5mm Phantom 18 M beam StrataXRT vs Common Treatment Regimen
StrataXRT reduces the severity of radiation induced skin reactions, therefore minimizing the probabilities of not complying with the planned radiation therapy.
S incare Overall Costs During Radiation Therapy Treatment Cost Extra nursing time needed to cut Nursing and adapt dressings time StrataXRT No nursing time Need to be carefully applied and Physical ad usted to avoid bolus effect dressings Self-applica le y patient
Not developed for Burn Developed for cream radiation dermatitis radiation dermatitis Moisturi ing StrataXRT cream Proven clinical efficacy No proven clinical efficacy Common treatments StrataXRT
How Much StrataXRT is Required StrataXRT gel is a unique formulation that requires substantially less product per application than typical moisturising creams or barrier ointments. Measurements at Different Energy Levels StrataXRT 0.35 oz (10g) StrataXRT 0.7 oz (20 g) StrataXRT 1.75 oz (50 g) with and without StrataXRT pplication contains enough gel for over contains enough gel for over Electron Beamcontains enough gel for over 1 week of treatment during a 12 1 Me -0 1 2 weeks of treatment during 5 weeks of treatment during standard1 fractionation plan*-0 1 a standard fractionation plan* a standard fractionation plan* cm
0 0 applying the0 gel twice per day. 0 12 applying the gel twice per day. 1 applying the gel twice per day.
10 SSD * Standard fractionation in head and neck cancer treatment is considered to be 6 weeks. 2 weeks post radiation8 are expected for toxicity peak and 2 weeks more for recovery of the skin. The standard therapy 10 10cm us.strataxrt.com time can therefore extend up to 2 weeks. ield Si e StrataXRT Solid Water Nanocloulombs Roos Chamber 2 Directions for use Recommended duration of treatment • Ensure 0that the affected skin or superficial wound is clean and dry. StrataXRT is recommended to be applied following the initial radiation dose and • Gently pat dry Me as much excess Me exudate12 orMe wound1 fluid Me from the area as possible prior should continue to be used for a minimum of 60–90 days (24/7) post-radiation to gel application. therapy, or until no further improvement is seen. For chronic radiation dermatitis, • Apply a very thin layer of StrataXRT directly to the affected area and allow the gel to dry. continued use is recommended until no further improvement is seen. with StrataXRT without StrataXRT • StrataXRT should be applied once or twice daily to the Ingredients: Polydimethylsiloxanes, siloxanes, alkylmethyl silicones affected areas or as advised by your physician. Caution: For external use only. StrataXRT should not be placed in contact with the eyes. • Once dry, StrataXRT may be covered by sunscreen, cosmetics and clothing. StrataXRT should not be applied over topical medications unless advised by your physician. • For best results StrataXRT should be maintained in continuous contact with the skin StrataXRT may stain clothing if not completely dry. Should your radiation dermatitis show (24 hrs/day). signs of infection or failure to heal, consult your physician. If irritation occurs, When applied correctly to the affected areas, StrataXRT should be dry in 5–6 minutes. discontinue use and consult your physician. Not suitable for highly exudative If it takes longer to dry, you have probably applied too much. Gently remove the excess wounds, tunneling wounds or 3rd degree burns. Keep out of the reach of with a clean tissue or gauze and allow the drying process to continue. StrataXRT children. Do not use after the expiration (EXP) date printed on the tube. may also be used in conjunction with other adjunctive treatments to improve overall STERILE UNTIL OPENED CV-US-001-2-0318 results. StrataXRT can be used with or without a secondary protective dressing.
References: Manufactured by: Stratpharma AG, Aeschenvorstadt 57, CH-4051 Basel, Switzerland 1 Porock D & Kristjanson L. Eur J Cancer Care. 1999;8:143–153 2 Kedge E. Radiography 2009;15:247–257 3 Wells M et al. Radiation skin reactions. In: Faithfull S et al. Class I Medical Device Supportive care in radiotherapy. London: Elsevier; 2003. p. 135–159 FDA Listed 4 Naylor W & Mallett J. Eur J Oncol Nurs. 2001;5(4):221–233 5 López E, Nuñez MI, Guerrero MR et al. Breast Cancer Res Treat. 2002;73(2):127–134 6 Hymes S et al. J Am Acad Dermatol. 2006;54(1):28–46 7 Bolderston et al. Supportive Care in Cancer 2006;14(8):802–817 Global Sales Office 8 McQuestion. Seminars in Oncology nursing 2006;22(3):163–173 th 9 Wickline. Oncology nursing forum 2004;31(2):237–244 1401 8 Street SE, USA 10 Bernier J. et al. Ann Oncol. 2008 Jan;19(1):142-9 Orange City, IA 51041 11 Trueman E. The Princess Royal Radiotherapy Review Team. 2011 12 Losi P et al. J Mater Sci Mater Med. 2012;23(9):2235–43 800.842.8688 | +1 712.737.8688 13 Data on file, Stratpharma AG, Basel, Switzerland, 2015 [email protected] | www.CivcoRT.com 14 Data on file, Stratpharma AG, Basel, Switzerland, 2017 15 Data on file, Stratpharma AG, Basel, Switzerland, 2015 COPYRIGHT © 2018. CIVCO IS A REGISTERED TRADEMARK OF CIVCO MEDICAL SOLUTIONS. ALL OTHER TRADEMARKS ARE PROPERTY OF THEIR RESPECTIVE OWNERS. ALL PRODUCTS MAY 16 Data on file, Stratpharma AG, Basel, Switzerland, 2015 NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. 2018P1367US REV. B