Overview & Clinical Efficacy Studies
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THE PAXMAN SCALP COOLING SYSTEM SYSTEM OVERVIEW & CLINICAL EFFICACY STUDIES
The Paxman Scalp Cooling System is globally recognised as the leading product for hair loss prevention during chemotherapy treatment. PAXMAN SCALP COOLING 1
About Paxman
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What is Scalp Cooling?
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The Paxman System
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Meet Orbis
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Paxman Cold Caps
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The Procedure
References Massey CS. A multi-centre study to determine the efficacy and patient acceptability of the Paxman Scalp Cooling System to prevent hair loss in patients receiving chemotherapy. Eur J Oncol Nursing; 8: 121-130,2004.
Published experiences with Paxman Scalp Cooling System efficacy and patient acceptability data. CLINICAL EFFICACY STUDIES
De Vries NF and Andersen OK, scalp cooling as a method of avoiding alopecia in cancer patients receiving chemotherapy. Presented at ECCO 11 Lisbon 2011. C.J.G. van den Hurk, M.E. van den Akkervan Marle et al. Impact of scalp cooling on chemotherapy-induced alopecia, wig use and hair growth of patients with cancer. Betticher et al, efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment; Support Care Cancer (2013) 21:2565–2573. C.J.G. van den Hurk et al, Acta Oncologica, 2012;00: 1-8 scalp cooling for hair preservation and associated characteristics in 1411 chemotherapy patients. Results of the Dutch Scalp Cooling Registry Professor Fadi Nasr, personal communication, publication in preparation.
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UK Study of Efficacy
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Netherlands Study of Efficacy 1
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Netherlands Study of Efficacy 2
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Netherlands Study of Efficacy 3
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Swiss Study of Efficacy
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Lebanese Study of Efficacy
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Safety Study Summary
TAC: Docetaxel, doxorubicin and cyclophosphamide
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Technical Information
AC:
Glossary of abbreviations FEC: 5-fluorourocil, epirubicin and cyclophosphamide FAC: 5-fluorourocil, Adriamycin and cyclophosphamide CMF: Cyclophosphamide, methotrexate and 5-fluorourocil
Doxorubicin, Endoxan4
CIA: Chemotherapy-Induced Alopecia.
ABOUT PAXMAN
1
THE LEADING GLOBAL EXPERTS IN SCALP COOLING Paxman has been pioneering scalp cooling technology for over a quarter of a century. Having carried out extensive trials and product development, we have created a system that is clinically proven, cost-effective and widely embraced by doctors, nurses and patients alike.
Passionate When Sue Paxman lost her hair while receiving chemotherapy for breast cancer, her family shared her distress. Sue’s husband, Glenn Paxman founded Paxman on the back of this experience and to this day we remain a close family business. Knowing first-hand the effects that both cancer and its treatment can have on patients, friends and families, our business is much more than just a job. We aim to make a difference to people’s lives by raising awareness about scalp cooling and establishing it as a common practice for all patients undergoing treatment.
Precise As the leading global manufacturer and supplier of scalp cooling equipment, we work in partnership with medical professionals, research centres, cancer support groups, charities and patients to continually improve our technology and expert knowledge base. Investing in scientific testing and development has allowed us to attain outstanding technical precision and the highest levels of clinical efficacy. We strive to gain further knowledge and understanding of hair loss prevention for cancer patients receiving chemotherapy.
Personal We are committed to giving patients a degree of control during chemotherapy treatment. We have made it our responsibility to offer advice, support and access to scalp cooling for cancer patients no matter where they are based in the world. Having been through the same journey as many patients and their families, we are dedicated to empowering people by giving them the choice to keep their hair.
WATCH THE PAXMAN STORY paxmanscalpcooling.com
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THE PAXMAN SCALP COOLING SYSTEM
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THE PIONEERS IN SCALP COOLING What is Scalp Cooling? Scalp cooling is a simple treatment that can prevent hair loss caused by certain chemotherapy drugs. The use of scalp cooling or ‘cold caps’ is proven to be an effective way of combating chemotherapy-induced hair loss and can result in a high level of retention or completely preserve the hair. For patients, this means the opportunity to regain some control, maintain their privacy and encourage a positive attitude towards treatment.
Why Chemotherapy Makes Hair Fall Out Chemotherapy works by targeting all rapidly dividing cells in the body. Hair is the second fastest dividing cell in the body and this is the reason why many chemotherapy drugs cause hair loss. The hair follicles in the growth phase are attacked resulting in hair loss approximately 2 weeks after the commencement of the chemotherapy treatment. The basic principle of chemotherapy is to damage the mitotic and metabolic processes in cancer cells. The reason this also affects hair follicles is because up to 90% of them will be in an active growth phase (anagen). Chemotherapy induces keratinocyte apoptosis and hair follicle regression, as well as the impaired metabolic and mitotic processes in anagen hair follicles, all of which results in rapid and extensive alopecia.
How Scalp Cooling Works The damage that chemotherapy causes to the hair follicle can be alleviated by using scalp cooling. It works by reducing the temperature of the scalp by a few degrees immediately before, during and after the administration of chemotherapy. This in turn reduces the blood flow to hair follicles which may prevent or minimise the hair loss. Cooling causes blood vessel vasoconstriction, which has been shown to reduce blood flow in the scalp to 20-40% of the normal rate, resulting in less chemotherapeutic drug being delivered to the hair follicles. The rate of drug diffusion across a plasma membrane is reduced by cooling and thus lower effective drug doses may enter the cells. Cell division is metabolism-driven - this process is decelerated by cooling. Also, a decrease in the metabolic activity of the cells in the hair follicle could cause a more general reduction in the cytotoxicity of chemotherapy drugs localised to the scalp.
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THE PAXMAN SYSTEM
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THE PAXMAN SCALP COOLING SYSTEM World-class System. World-class Service. The Paxman Scalp Cooling System is globally recognised as the leading product for hair loss prevention during chemotherapy treatment. Tested and developed for over a quarter of a century, the system features the highest levels of clinical efficacy, hospital safety and patient comfort. Used with a wide range of cancer types, with most commonly used chemotherapy drug regimes, the Paxman Scalp Cooling System is specifically designed to meet the needs of both patients and nursing staff. A compact unit means the system can be easily operated, quickly transported and efficiently stored. Our advanced technology delivers best practice across the board.
Benefits • Clinically proven success rates • Takes up little nursing time • Lightweight caps and easy to use, low maintenance system • High level of patient tolerance • Support packages available • Manufactured in the UK
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THE PAXMAN SCALP COOLING SYSTEM
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MEET ORBIS The Paxman Scalp Cooling System is powered by the Orbis machine, available in two models to allow either one patient to be treated or two patients to be independently treated at the same time. Orbis offers many benefits for use in hospitals, small chemotherapy suites and private beds. Providing the leading scalp cooling technology for hair loss prevention, the system consists of a compact refrigeration unit containing a coolant that is circulated through specially designed cooling caps. The coolant lines are supported by a raised, adjustable arm to offer maximum comfort for the patient.
Features • Single or dual patient treatment, which are independently controlled. • Easy to read touch screen visual display with system status graphics. • One touch switch operation for simple ease of use. • Scientifically developed, low temperature, non-viscous coolant with ultra efficient heat transfer properties. • Instant cooling capability once connected to the system to allow immediate use. • Visual and audible alarms for restricted and no flow coolant conditions. • Countdown timer with touch screen access and visual display. • System diagnostics access for operators. • Coded access for service engineers. • High ambient warning alarm. • Small, compact size which is easily manoeuvred.
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THE PAXMAN SCALP COOLING SYSTEM
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PAXMAN COLD CAPS The most important feature of Orbis is the lightweight design of the cooling caps (small cap 404g). Manufactured from high grade silicone material, the soft, flexible cooling caps provide a close fit around the patient’s head. Five different sizes are colour coded so they can be easily identified, and the varying dimensions ensure most head shapes are catered for. As coolant passes through the cap to extract heat from the patient’s scalp, inline temperature sensors ensure the cap maintains the scalp at an even, constant temperature. A neoprene cover is provided with the Paxman cap to assist in the efficiency and operation of the system. Insulating it and protecting it from high room temperatures, the cover absorbs condensation and ensures good contact with the scalp – an essential factor for successful treatment. Paxman caps are attached to the scalp cooling system with easily operated, quick release and non-drip plastic couplings. Once the treatment is finished, the cap can be disconnected from the coolant line and cleaned in accordance with hospital protocol ready for the next patient. Simple, proven performance.
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THE PAXMAN SCALP COOLING SYSTEM
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THE PROCEDURE For a successful treatment, the scalp needs to be maintained at a constant temperature. This is achieved by the correct fitting of the cap. Switch on the machine and allow it to reach operating temperature. This takes approximately 30 to 40 minutes and indicates when the system is ready to use on the touch screen display. Select the appropriate sized cooling cap, connect it to the system and place it on the patient’s head. Pre-cooling of the scalp takes 30 minutes prior to commencement of drug infusion. This ensures the scalp is at the required temperature before chemotherapy is administered. Patient preparations can take place during the pre-cooling period. The cap should be worn throughout the administration of the chemotherapy drugs and for 90 minutes afterwards. The system requires minimal nursing supervision so that it is accommodating for both patients and healthcare professionals.
Patient Flexibility Due to the lightweight nature of the caps, patients can relax during the cooling process, engage in a number of activities and visit the bathroom without affecting their treatment.
Nursing Flexibility The system is simple to operate with easy to read displays. It is compact and manoeuvrable therefore post-infusion cooling does not need to be carried out in the infusion chair.
Termination of Cooling A nurse should assist with the removal of the cap and the patient can be left to acclimatise before leaving the hospital. The system can be left running for continuation of the second patient, left running awaiting a new patient, or simply switched off.
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UK - STUDY OF EFFICACY
UK observational study reports an 89% success rate following use of the Paxman system in breast cancer patients, with only 11% with severe hair loss requiring wigs.
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Results
EVALUATION OF HAIR LOSS (ALL PATIENTS)
Alopecia prevention.
50
39
• Of patients receiving chemotherapy (n=95), grade 3 hair loss was observed in 5 patients and grade 4 hair loss in one patient (only 11% of patients required wigs).
% PATIENTS
33
• 5 out of 95 patients discontinued scalp cooling treatment. 17
• Of patients receiving FEC specifically (n=62), grade 3 hair loss was observed in 2 patients and grade 4 hair loss in one patient (only 13% of patients required wigs).
5
1
0 0
1
2
3
4
HAIR LOSS GRADE
Patients Patients reported high comfort and acceptability levels with low numbers of withdrawals from scalp cooling.
EVALUATION OF HAIR LOSS (FEC PATIENTS) 50
• 85% of patients reported that they were comfortable, reasonably comfortable, or very comfortable during the scalp cooling period.
% PATIENTS
42
• 12% of patients reported they were uncomfortable with an additional 3% very uncomfortable.
27
• Only 5% of patients discontinued scalp cooling before the end of chemotherapy treatment, with discontinuation because of discomfort seen in one patient.
18
3
2
3
4
0 0
1
2
HAIR LOSS GRADE
• Headaches at some time during treatment cycles were reported in 32% of patients.
Methods • 95 breast cancer patients being treated with chemotherapy in the adjuvant or palliative setting1. • Open, non-randomised, observational study conducted at 8 UK sites between 1997-2000. • Chemotherapy regimens include: • Epirubicin (60-75 mg/m2) regimens as monotherapy (10 patients) or the FEC combination therapy regimen used 1997-2000 (62 patients). • Doxorubicin as monotherapy or combination administered to 11 patients (doses ranging from 30-60 mg/m2).
89
%
success rate in breast cancer patients following use of the Paxman system.
• Docetaxel single agent (75-100 mg/m2) (n=5) CMF** (n=5).
Scalp cooling times: • Pre-infusion cooling time of 15-20 minutes. • Cooling was maintained during the infusion period. • Post-infusion cooling time of 120 minutes for majority of patients.
Hair loss graded according to criteria: GR 0
No significant hair loss
GR 1
Minor hair loss not requiring wig
GR 2
Moderate hair loss but not requiring wig
GR 3
Severe hair loss requiring a wig
GR 4
Total alopecia
Patient age range 28-61 years, mean age 44. Patients completed questionnaires related to comfort and acceptability of scalp cooling.
Massey CS. A multi-centre study to determine the efficacy and patient acceptability of the Paxman Scalp Cooling System to prevent hair loss in patients receiving chemotherapy. Eur J Oncol Nursing; 8: 121-130,2004.
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NORWEGIAN - STUDY OF EFFICACY 1
Norwegian observational study reports a 92% success rate following use of the Paxman system in 54 breast cancer patients treated with FEC/FAC or paclitaxel.
15 EVALUATION OF HAIR LOSS
Results
(ALL PATIENTS)
47
% PATIENTS
50
Alopecia prevention. Authors concluded that scalp cooling is an effective method for avoiding alopecia in patients receiving FEC or weekly paclitaxel. Only 8% of patients experienced significant hair loss.
30
15
8 0 None
Minor
Moderate
HAIR LOSS GRADE
Significant
Patients 89% of patients described scalp cooling as acceptable, with minimal discomfort caused by the longer treatment period. • Only 15% of patients considered coldness to be a major problem. • Only 2% of patients considered headaches to be a major problem. • One patient discontinued treatment because of discomfort.
92
%
success rate in breast cancer patients.
Methods • 54 breast cancer patients being treated with chemotherapy in the neo-adjuvant, adjuvant or palliative settings in single Norwegian centre between 2000-20012.
Chemotherapy regimens: • FEC*/FAC - epirubicin (60 mg/m2). • Weekly paclitaxel (P) (90 mg/m2).
Scalp cooling times: Pre-infusion cooling time • FEC/FAC: median 20 minutes (range 15-150 minutes). • P: median 20 minutes (range 15–120 minutes). • Cooling was maintained during the infusion period.
Post-infusion cooling time • FEC/FAC: median 120 minutes (range 120-150 minutes). • P: median 60 minutes (range 60–120 minutes).
Patient age range 28–61 years, mean age 44 • Patients views related to comfort and acceptability of scalp cooling were collated by contact nurse. *FEC - 5-fluorouracil, epirubicin and cyclophosphamide *FAC - 5-fluorouracil, adriamycin and cyclophosphamide ** CMF - Cyclophosphamide, methotrexate, 5-fluorouracil P - Paclitaxel
De Vries NF and Andersen OK. Scalp cooling as a method of avoiding alopecia in cancer patients receiving chemotherapy. Presented at ECCO 11 Lisbon 2011.
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NETHERLANDS - STUDY OF EFFICACY / 1
Observational study reports a 40% reduction of head covers when using the Paxman system in breast cancer patients.
17 EVALUATION OF HAIR LOSS SCALP COOLED PATIENTS (n=160) 90
Results • A head cover was still used by 51% of the scalp cooled patients, so improvement in effectiveness is desirable.
30
NO. OF PATIENTS
• 38% of scalp cooled patients were thought to have purchased a wig needlessly.
48
25
• Arrangements are made by patients’ hairdressers to consult and reserve a wig before chemotherapy.
7 0 No
Mild
Pronounced
Total
HAIR LOSS GRADE
NON SCALP COOLED PATIENTS (n=86) 90
NO. OF PATIENTS
78
2
6
Mild
Pronounced
• This arrangement should not be restricted to scalp cooled patients, as the incidence of CIA without scalp cooling is sometimes overestimated. • Study carried out by Mols et al, 2009 in breast cancer patients (n=175) were satisfied with their wig, however two thirds of them felt it was expensive which, again is a reason for postponing the purchase.
EVALUATION OF HAIR LOSS
0
• Another study conducted by Auvinen et al, 2010 showed unnecessary purchases totalled to 80%.
• The high frequency of wigs and head covers purchased to camouflage potential hair loss illustrates the importance of CIA for patients undergoing systemic therapy. • While some patients lose almost all of their hair but do not wear a head covering and vice versa, it has come to our attention that head cover use still best reflects the patients’ satisfaction with scalp cooling.
Purchase and use of wig and head cover (from before starting chemotherapy to 6 months after chemotherapy) and growth of hair during and after chemotherapy (n= 246).
0 No
Total
HAIR LOSS GRADE
PURCHASE/USE
GROWTH
SATISFIED WITH CURRENT HAIR STYLE
Wig and head cover
Scalp cooled (n=160)n(%)
Non scalp cooled (n=86)n(%)
Purchase wig
84 (53)
66 (77)
Used wig
52 (33)
59 (69)
Purchased head cover
117 (73)
83 (97)
Used head cover
81 (51)
78 (91)
During chemotherapy
31 (24)
5 (7)
Within 3 weeks after chemotherapy
19 (19)
10 (16)
3-6 weeks after chemotherapy
45 (46)
27 (43)
6-8 weeks after chemotherapy
18 (18)
18 (28)
8 weeks after chemotherapy
17 (17)
8 (28)
Missing
30
18
3 weeks after chemotherapy
111 (85)
57 (78)
6 months after chemotherapy
111 (94)
50 (86)
Methods • In this observational study Dr. Corina van den hurk et al, 2013 looked at scalp cooled patients (n=160) compared to non scalp cooled patients (n=86), all with several types of cancers. • Patients were spread across 13 different hospitals, 2 of which did not have scalp cooling available.
40
%
reduction in the use of head covers.
Chemotherapy regimens include: • Taxane and/or anthracycline-based chemotherapy. • FEC (5-Fluorouacil, Epirubicin, Cyclophosphamide) regimen used 1997-2002 (62 patients).
Scalp cooling times: • Pre-infusion cooling time 30 minutes.
38
%
of scalp cooled patients thought to have purchased a wig needlessly.
• Cooling was maintained during the infusion period. • Post-infusion cooling time of 90 minutes for majority of patients. • Hair loss graded according to questionnaire format below.
Patient age range was: Age (years)
Scalp cooled n=160 (%)
Non scalp cooled n=86 (%)
<49
70 (44%)
43 (50%)
50-59
63 (39%)
29 (34%)
>60
27 (17%)
14 (16%)
Patients completed questionnaires related to comfort and acceptability of scalp cooling. Observational study was scored using the WHO & VAS system. Hair loss graded according to criteria in below: GR 0
None
GR 1
Mild
GR 2
Pronounced
GR 3
Total
Long duration of CIA, the wish of patients to camouflage or rather prevent it and the reduced need for head covering in 40% of the patients, makes scalp cooling a worthwhile supportive intervention.
C.J.G. van den Hurk, M.E. van den Akkervan Marle et al. Impact of scalp cooling on chemotherapy-induced alopecia, wig use and hair growth of patients with cancer.
Improvement can be obtained by studying scalp cooling times (Hurk van den et al., 2012a) and temperatures, by adapting indications (e.g. type of chemotherapy and patient motivation), but also by adapting patient information about CIA and scalp cooling. For example, patients should be advised not to buy a wig as a precaution, but to wait until it becomes necessary. The use of scalp cooling will probably increase, because of increasing cancer incidence, more frequent use of chemotherapy in solid tumours and improved acquaintance with scalp cooling in hospitals, but also among patients. In order to compare scalp cooling outcomes in the future, a questionnaire should be developed and validated to evaluate the extent of CIA and its impact on patient’s lives.
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