The objective is to reduce the possibility of hair loss or the need to wear a covering aid on your head during chemotherapy. Please note that this is NOT an experimental procedure or a clinical trial.
Scalp cooling is a well-accepted approach in many places around the World and tens of thousands of oncology patients receive it annually. The history of scalp cooling dates back over 30 years, with 56 Trials conducted between 1973-2003 and many more since then. The average success rate of the studies carried out before 1995 was 56% and 73% in the studies carried out from 1995 onwards and we continue to improve on this.
Chemotherapy-induced alopecia (hair loss) (CIA) occurs with an estimated incidence of 65% (Trüeb, 2009). CIA is often categorised as anagen effluvium in which hair follicles in the growth phase (anagen) are attacked by chemotherapy agents resulting in almost total atrophy of the hair follicle. This results in the shedding of the affected hairs approximately 2 weeks after the commencement of chemotherapy. The damage that chemotherapy causes to the hair follicle can be alleviated using a scalp cooling device. The optimum temperature for scalp cooling is not yet known but studies show that 22oC is mostly effective:
- In one study good hair retention was achieved when the scalp temperature was cooled to <22oC (Gregory, 1974)
- Keratinocyte growth inhibition is greatly reduced when cells are incubated at 22oC during chemotherapy exposure compared to 37.5oC. (Paxman IV project,2011 & Janssen,2008)
There are two scientific scalp cooling rationale that are frequently quoted in literature:
- Cooling causes vasoconstriction which reduces blood perfusion rate and consequently reduces the amount of cytostatic drugs reaching the hair follicles.
- Cooling reduces the metabolic rates of biochemical processes which result in less damage being made to the hair follicles.
More recently, academics are studying the role that the p53 tumour suppressor plays in CIA and the prevention of CIA through scalp cooling
Here is a summary on the safety of scalp cooling:
Safety of Scalp Cooling in the Management of Chemotherapy-Induced Alopecia
As a result of the use since the 1970's of scalp cooling for the reduction of chemotherapy-induced hair loss, the side-effects associated with scalp cooling are well known.
Short- to Medium-Term Side Effects
Known short- to medium-term side effects recognised as being associated with scalp cooling include:
- cold discomfort (during scalp cooling);
- headache (during and after scalp cooling);
- forehead pain (during scalp cooling) caused by pressure and tightness of the cooling cap;
- dizziness or light-headedness (during scalp cooling);
All of the above occur during the scalp cooling process, are transient in duration and are generally recognised as presenting a low risk of harm (although in some cases, patients have discontinued scalp cooling because of these effects).
Of more clinical significance are the potential consequences of scalp cooling in patients who suffer from either:
- Cold urticaria - an allergic reaction to cold temperature which results in welts on the skin. There is a risk that scalp cooling could elicit a severe anaphylactic reaction, which can be life-threatening; or,
- Cold agglutinin disease - individuals with this condition have high concentrations of circulating antibodies to red blood cells. There is a risk that scalp cooling could cause the low-temperature binding of these antibodies to the patient's red blood cells, potentially resulting in haemolytic anaemia.
Scalp cooling is typically contraindicated in individuals known to be, or suspected of being, affected with either of the above conditions.
Long-Term Side Effects
The only known potential long-term side-effect of scalp cooling is also the most controversial one; this is that scalp cooling, when used on patients receiving chemotherapy for breast cancer, could lead to an increased incidence of scalp metastases (because the same mechanisms that restrict the effectiveness of the chemotherapeutic agent against hair follicle cells in the scalp will also restrict its effectiveness against cancerous tissue in the scalp).
Concerns over the risk of increased incidence scalp metastases following scalp cooling and the lack of long-term safety data from published scalp cooling studies to address this risk led the US FDA in 1990 to ban the commercial distribution of cryogel caps in the USA for the purpose of scalp cooling.
However, in the time since the FDA ban on cryogel caps, a number of oncologists have published studies specifically aimed at investigating the long-term incidence of scalp metastases following scalp cooling. In a review of scalp cooling by Grevelman and Breed  that included 56 studies and approximately 2,500 patients across 56 separate studies, scalp metastasis was reported in just nine patients (0.36%). In a total of 24 of the 56 studies reviewed, specific attention was paid to the risk of scalp skin metastases following the use of scalp cooling. It was reported that no scalp skin metastases were found in 16 of these studies. The follow-up time of the studies included in the review varied from 2 months to 63 months.
In 2006, Christodoulu et al  reported on a series of 227 breast cancer patients who underwent scalp cooling with a cold cap while receiving chemotherapy.. Two of the breast cancer patients (0.88%) developed scalp metastases. Both of these patients had advanced cancer with multiple metastatic sites. Although the follow-up period for this study was not specified, the authors concluded that "the incidence of scalp metastases in patients using scalp cooling methods during chemotherapy is low and it does not seem to influence the clinical outcome."
In a prospective multicentre study by Spaeth et al , 911 cancer patients were included from 2002 to 2006. . Eight hundred and seventy-six of these patients were women, most with localized or advanced breast cancer, whom were treated with adjuvant chemotherapy or palliative chemotherapy. There were 770 cancer patients who chose chemotherapy with scalp cooling and 141 who chose to have chemotherapy without scalp cooling. During the follow- up, a minimum time of at least 2 years, there were one cutaneous scalp metastasis and two subcutaneous scalp metastases occurring among the patients who had scalp cooling, and no scalp metastases among the patients who abstained from scalp cooling. The brief report does not give any indication of what kind of primaries the three patients with scalp metastases had, or if the chemotherapy was given as adjuvant treatment or as palliative treatment for advanced disease involving other sites of metastases.
In 2009, Lemieux et al  reported on a retrospective cohort study of women diagnosed with invasive breast cancer between June 1998 and June 2002 at a single institution in Quebec. Scalp cooling was routinely offered to women with breast cancer. Of a total of 640 patients included, 86.4% received scalp cooling during neoadjuvant or adjuvant chemotherapy. Six patients (1.1%) in the scalp cooling group developed scalp metastases (with or after the diagnosis of metastases to multiple other sites), along with one patient in the control group (1.2%). The rate of scalp metastases in the scalp cooling group and the control group was not statistically different. In this cohort, scalp metastases never presented as the sole metastatic site and these patients with scalp metastasis had widely metastatic disease. See table 1 below for details of the 7 patients with scalp metastasis.
Rugo and Melin  analysed all the literature to date in a correspondence . This included a 1972 study by Browstein and Helwig where metastatic sites were identified in a study of 167 women with breast cancer and cutaneous metastasis who did not receive chemotherapy. The incidence of scalp involvement in these women with cutaneous metastasis was only 3%. The authors also emphasized that the scalp metastasis in women with breast cancer usually occurred late in the disease. Furthermore Rugo and Melin, looked at three studies from 1976 to 2009, involving a total of 2,697 breast cancer patients who received chemotherapy without scalp cooling and who were followed up for around 5 years; the incidence of scalp metastases ranged from 1.2% to 2.5% (while the incidence of all skin metastases ranged from 24% to 30%). When breast cancer is metastatic and involves the skin or scalp, the breast cancer is usually widespread and it would be exceedingly rare to have breast cancer recur with the scalp as the only site of metastatic disease. It is also exceedingly rare for scalp metastases to be the first site of recurrence in breast cancer patients.
In consideration of scalp metastases as the first site of recurrence of cancer, Rugo and Melin looked at reference data from the National Surgical Adjuvant Breast and Bowel Project (NSABP), involving 7,800 women with breast cancer treated with surgery alone or combined with chemotherapy (Rugo 2010). Of these 7,800 women, only 2 (0.025%) experienced scalp metastasis as their first site of recurrence. Both of these patients had positive lymph nodes and one of them had received adjuvant chemotherapy. It is not mentioned in the correspondence how many of these women had skin metastases or scalp metastases. Rugo & Melin's expert opinion was "that scalp cooling can and should be offered to breast cancer patients who will be treated with adjuvant chemotherapy, and also those who are offered palliative chemotherapy associated with a significant risk of alopecia. The risks involved appear to be extremely small and the potential gain for the large number of women receiving adjuvant chemotherapy for breast cancer in the United States is substantial.
- Grevelman EG, Breed WP. Prevention of chemotherapy-induced hair loss by scalp cooling. Ann Oncol, 2005; 1
- Christodoulou C, Tsakalos G, Galani E, Skarlos DV. Scalp metastases and scalp cooling for chemotherapy-induced alopecia prevention. Ann Oncol, 2006; 17(2): 350
- Spaeth D, Luporsi E, Weber B, Guiu S, Braun D, Rios M, Evon P, Ruck S. Efficacy and safety of cooling helmets (CH) for the prevention of chemotherapy-induced alopecia (CIA): a prospective study of 911 patients. J Clin Oncol, 2008; 26 (20 Suppl): 9654.
- Lemieux J, Maunsell E, Provencher L. Chemotherapy-induced alopecia and effects on quality of life among woman with breast cancer: A literature review. Psychooncology, 2008; 17(4): 317-328. 5. Rugo HS, Melin SA.
- Expert statement on scalp cooling with adjuvant/neoadjuvant chemotherapy for breast cancer and the risk of scalp metastases, April 2010 [personal communication].