Aetna considers scalp cooling (i.e., using ice-filled bags/bandages, cryogel packs, or specially designed devices) experimental and investigational as a means to prevent hair loss during chemotherapy because the effectiveness of this process has not been established.

Hair loss is a potentially distressing side effect of several cytotoxic drugs. Scalp cooling has been suggested to prevent hair loss. In a review of the literature Tollenaar and associates (1994) noted that scalp hypothermia might prevent alopecia only in a cytotoxic regimen containing an anthracycline as the sole alopecia-inducing agent. With current adjuvant chemotherapy for breast cancer, in which a combination of cyclophosphamide and an anthracycline is often used, there is no place for scalp hypothermia. In this regard, Christodoulou et al (2002) reported that the MSC cold cap system is effective in preventing alopecia from anthracycline, etoposide or taxane, but not from anthracycline-taxane combinations or ifosfamide-containing regimens. Protiere, et al. (2002) reported on the results of scalp cooling in 105 women with breast cancer receiving adjuvant chemotherapy with mitoxantrone and cyclophosphamide compared with 109 similarly treated women who were not offered scalp cooling. Although the nurses and subjects reported less hair loss with scalp cooling, study subjects were not randomly assigned to treatment groups, and the study did not include a sham control so that neither the study subjects nor the nurse assessors were blinded to treatment allocation.

In a non-randomized pilot study, Ridderheim et al (2003) reported that a new digitized scalp-cooling system is safe and effective in preventing chemotherapy-induced alopecia in female patients (n = 74). The authors concluded that this new system makes it suitable for use in future randomized clinical trials designed to explore optimal temperatures and durations of cooling for different chemotherapy regimens in hopes of broadening the application of hypothermia for alopecia prevention in cancer patients. The authors stated that more data is needed on adjuvant treatment of breast cancer patients and long-term effects.

In a randomized controlled study, Macduff et al (2003) examined the effectiveness of scalp cooling in preventing alopecia for breast cancer patients (n = 30) receiving the combination chemotherapy of epirubicin and docetaxel. The authors concluded that the benefits of scalp cooling in patients treated with taxanes and anthracycline drugs are clearly marginal and less impressive than for some single drug breast cancer chemotherapy regimens. Despite the limitations of small numbers of patients and high dropout (n = 9), this study has been useful in establishing the extent, and illuminating the nature, of the marginal benefits and disadvantages of having this treatment. In addition, exploratory analyses have raised further questions regarding the criteria for clinical significance and how to prospectively identify individual patients who may do well in scalp cooling treatment.

In a review on the prevention of chemotherapy-induced hair loss by scalp cooling, Grevelman and Breed (2005) stated that scalp cooling is effective but not for all chemotherapy patients. These investigators noted that further psychological, clinical and biophysical research is needed to ascertain the exact indications for cooling and to improve the effect, tolerance, side-effects and the cooling procedure. The authors stated that multi-center clinical studies should be performed to gather this information.

An assessment of scalp cooling by the the Swedish Council on Technology Assessment in Health Care (SBU, 2005) concluded that "[f]urther studies of patient benefit, risks, and cost effectiveness are needed".  Spaeth et al (2006) stated that "scalp cooling (helmets or continuous cooling systems) can avoid or diminish hair loss in selected chemotherapy regimens but tolerance can be fair and long harmlessness needs to be confirmed by prospective studies".

In a systematic review on non-pharmacological strategies for managing common chemotherapy adverse effects, Lotfi-Jam K et al (2008) stated that findings from randomized controlled trials (RCTs) of reasonable quality provided limited support for cognitive distraction, exercise, hypnosis, relaxation, and systematic desensitization to reduce nausea and vomiting, psycho-education for fatigue, and scalp cooling to reduce hair loss. The authors concluded that although some strategies seem promising, the quality of the RCTs was generally quite low, making it difficult to draw conclusions about the effectiveness of self-care strategies. Future studies with better design and reporting of methodological issues are needed to establish evidence-based self-care recommendations for people receiving chemotherapy.

Mols et al (2009) described the effectiveness and burden of scalp cooling and the satisfaction with wigs, with hair re-growth, and with body image. Breast cancer patients treated with (n = 98) and without (n = 168) scalp cooling completed questionnaires before chemotherapy and 3 weeks and 6 months after completion of chemotherapy. Scalp cooling was effective in preventing chemotherapy-induced hair loss in 32 of 62 available patients (52 %). Even though patients knew hair loss was temporary, it was a burden to 54 % of them (n = 100). Scalp cooling was a burden for only 17 out of 51 patients (33 %). Most patients who used a wig or head cover were satisfied with it (82 %, n = 126). Patients were moderately satisfied with the regrowth of their hair after chemotherapy. Successfully cooled patients rated their hair as less important for their body image compared to patients who did experience hair loss (p = 0.014). The authors concluded that chemotherapy-induced hair loss is perceived as burdensome. It may be prevented by offering scalp cooling which is often an effective method to prevent this form of hair loss and is well-tolerated by patients. However, if possible, scalp-cooling techniques should be improved and their effectiveness should be increased because if scalp cooling is unsuccessful, patients' rate their hair loss as more burdensome compared to non-cooled patients.