At the Centre François Baclesse in Caen, researchers and nurses are currently investigating the differences in efficacy between manual gel caps, commonly used in France, and the Paxman Scalp Cooling System. In line with the French clinical guidelines surrounding supportive oncological care approved and published by AFSOS in May 2022, the ICELAND Study hopes to clearly demonstrate the superiority of mechanised scalp cooling, a method which circulates coolant across the scalp at a consistent temperature. The study, a randomised, controlled multicentric study, will involve multiple Unicancer centres, not only the Centre François Baclesse in Caen but also other Unicancer centres located in Lille and more recently Toulouse.
Manual gel caps – frozen before being placed onto the scalp and replaced frequently during treatment – have historically been the de facto treatment solution in France to address chemotherapy-induced alopecia. However, these have often been plagued with major problems in comfort, weight and cap fit, in addition to its time intensive practical application by care teams. The study is also investigating the perceived comfort of the two cold cap treatment methods, using criteria such as tolerability to the cold and the duration of treatment.
At the centre in Caen, Paxman interviewed François Gernier, Healthcare Research Coordinator, and Charlotte Dupont, the Communications Manager who has carried the project through from start to finish. They explained that “gel caps have rarely been efficacious or comfortable for patients. In some cases, healthcare professionals from the Centre François Baclesse have observed an almost ‘ridiculously’ low rate of success, despite their usage.”
On the other hand, the centre, which possesses several Paxman systems for the purposes of the study, has anecdotally observed a much better efficacy in terms of hair retention, especially those treated with taxane-based chemotherapy regimens. François told the story of one woman treated with this type of regimen who had unfortunately lost her hair using the gel cap, but “after recently needing chemotherapy again a second time, she kept all of her hair with the Paxman system”.
Hair loss is often the most feared side effect by chemotherapy patients. According to François and Charlotte, many patients only accept chemotherapy treatment if there is a chance of retaining their hair, which clearly signifies that body image, self-esteem and avoiding the stigma around chemotherapy-induced alopecia, is incredibly important to them personally.
At the Centre François Baclesse, and indeed through clinical studies and years of feedback to Paxman from hospitals, a clear difference in patients’ quality of life has been observed with the Paxman system compared to no intervention at all. This randomised, comparative study hopes to demonstrate clear evidence that a mechanised scalp cooling system, that can deliver cooling evenly and consistently, should be the medical device of choice for preventing chemotherapy-induced alopecia. François reiterated that the objective of scalp cooling is to allow patients “to see themselves in the mirror without wearing a scarf, head cover or wig” and if this can be better achieved with a mechanised system, then the approach to treatment needs to change.
François and Charlotte continued to set the scene for us in France, stating that historically, many oncologists consider hair loss as a secondary, inevitable side effect of chemotherapy and don’t make their patients aware of the potential to avoid it.
Using the PSCS as part of the study allows for, in the words of François Gernier, “changing the norm”, showing that prevention of hair loss is possible as well as efficacious. However, positive involvement and adoption from nurses is essential when convincing medical professionals of its benefits.
The ICELAND Study will include a method with which to assess the medico-economic impact of the PSCS verses the gel cap method, encompassing a range of factors:
Assessing these factors could lead to a much stronger case in wider implementation of mechanised scalp cooling, even if its positive impact is already acknowledged anecdotally, by François, the team of nurses and their patients.
As the Paxman system is a significant change to the traditional manual cap method adopted in France, the study team recognises there are a number of challenges to overcome within the wider healthcare system – all for the greater good, however.
As a mechanised system, it requires training by medical staff on how to use it. It’s not as simple as taking a manual cap from the freezer and placing it on the patient’s head, but learning how to fit a Paxman cap properly, for example, makes a huge difference to outcomes. Comprehensive training is provided by Paxman as part of the implementation process and is designed to get centres ready to deliver scalp cooling as quickly as possible.
On a personal level, many people can be resistant to change – it can often bring uncertainty, and we naturally prefer predictability. We’re inclined to maintain the status quo as it feels familiar, keeps us within our comfort zone and requires less effort. For medical professionals administering scalp cooling, there is less of a personal incentive for these reasons but if we imagine that a patient at risk of losing their hair had the power themselves to enact this change, we’d likely see rapid and widespread adoption much quicker.
François and Charlotte spoke about certain centres struggling to integrate an updated scalp cooling method due to resistance to change and highlighted the need to convince healthcare professionals that hair loss no longer inevitable. He explained that in certain centres, caregivers are still telling patients “You are going to lose your hair”, even when using manual gel caps.
This development of confirmation bias through personal experience administering a manual cap has led to an unfair and generalised stance on scalp cooling. With less-than-ideal results, combined with the resource intensive need to replace the cap approximately 6 or 7 times per patient, it is no surprise that medical staff feel disillusioned or apathetic towards the treatment. However hard, undeniable evidence from this ongoing study, should hopefully start to change attitudes country wide.
The Paxman System has been integrated into the care pathway of chemotherapy patients by the nursing team at the Centre François Baclesse, particularly for those receiving taxanes. Whilst the centre was unable to share any data with us at the moment (the trial is still ongoing and we expect results in 2026), the sentiment from the team towards the PSCS appears very favourable. Alongside hopes that the results from the study will accelerate adoption of mechanised scalp cooling, the centre also plans to monitor patients for 4 to 6 months after their final treatment to assess the impact of both methods of scalp cooling on long-term alopecia.
With almost 100 patients recruited into the study so far, Paxman is optimistic about favourable results for the system – results which could help challenge entrenched practices and lead to better results for French patients in the future.
François signed off the interview with a profound message to cancer centres in France and throughout the world:
“Chemotherapy-induced alopecia is not inevitable. It must be treated like any other symptom. Hospitals and cancer treatment centres have a duty to offer a solution to hair loss. Offering an opportunity to keep one's hair should be as much a part of treatment as anti-vomiting medication.”
