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.Background
Hair loss is a potentially distressing side effect of several cytotoxic drugs. Scalp cooling has been suggested to prevent hair loss.
A Medicare National Coverage Determination explains that keeping the scalp cool during chemotherapy has been noted to reduce the risk of hair loss. The cooling may be done by packing the scalp with ice-filled bags or bandages, or by specially-designed devices filled with cold-producing chemicals activated during chemotherapy. The NCD states that while ice-filled bags or bandages or other devices used for scalp hypothermia during chemotherapy may be covered as supplies of the kind commonly furnished without a separate charge, no separate charge for them would be recognized.
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 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.
In a review on chemotherapy-induced alopecia (CIA), Trueb (2009) stated that the major approach to minimize CIA is by scalp cooling. Unfortunately, most published data on scalp cooling are of poor quality. Several experimental approaches to the development of pharmacologic agents are under evaluation and include drug-specific antibodies, hair growth cycle modifiers, cytokines and growth factors, anti-oxidants, inhibitors of apoptosis, as well as cell-cycle and proliferation modifiers. Ultimately, the protection should be selective to the hair follicle (e.g., topical application such that the anti-cancer effectiveness of chemotherapy is not hampered). Among the few agents that have been evaluated so far in humans, AS101 and minoxidil were able to reduce the severity or shorten the duration of CIA, but could not prevent CIA.
Auvinen and colleagues (2010) analyzed the effectiveness of scalp cooling caps in preventing CIA among 64 patients. Subjects were given one of the following chemotherapeutic treatments: (i) doxorubicin 60 mg/m2, (ii) docetaxel 80 mg/m2, (iii) FEC (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2, cyclophosphamide 600 mg/m2) or (iv) the combination of 3 cycles of docetaxel (80 mg/m2) followed by 3 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2, cyclophosphamide 600 mg/m2). All the chemotherapy treatments were given in a thrice-weekly schedule. Patients with early stage disease were given 6 adjuvant chemotherapy cycles, while patients with metastatic disease were given 9 chemotherapy cycles. Patients were provided with detailed instructions on how to treat the hair at home for 1 to 3 days following the chemotherapy treatment. Hair loss was evaluated after the 3rd, 6th and final treatments. In the final results, major hair loss was avoided in all patients given doxorubicin treatment, in 83.3 % of patients given docetaxel treatment, in 76.5 % of patients given FEC treatment, and in 78 % of patients given docetaxel followed by FEC. In the final evaluation, 87.5 % of the patients considered the avoidance of hair loss to be important. Only 20.3 % of the patients needed to use a wig. The authors concluded that these findings showed that all the patient groups studied gained some benefit by using scalp cooling caps. The findings of this small study need to be validated by well-designed studies.
van den Hurk and associates (2010) evaluated the effect of scalp cooling on well-being of breast cancer patients with CIA. A prospective multi-center study was performed in 13 hospitals. Breast cancer patients treated with (n = 98) and without (n = 168) scalp cooling completed questionnaires (EORTC QLQ-C30 and EORTC-QLQ-BR23, BIS, MBA, HADS) before chemotherapy, and 3 weeks and 6 months following the last chemotherapy cycle were included in this analysis. Scalp cooling was effective in 52 % of the cases. Alopecia was considered among the most distressing problems at all 3 moments of measurement. A trend towards higher well-being was found in successfully scalp-cooled patients, as indicated by a general better health-related quality of life and better body image, whereas unsuccessfully scalp-cooled patients reported lowest well-being. The authors concluded that scalp cooling contributes not only to the well-being of successfully scalp-cooled patients but also seems to cause additional distress when patients lose their hair despite scalp cooling. This might be related to disappointment due to alopecia despite scalp cooling or possibly to a general higher biological availability of cytostatics. The authors recommended additional support for patients when scalp cooling is not successful and to spend more effort to maximise the effectiveness of scalp cooling.
In a review on CIA, Trueb (2010) stated that 47 % of female patients consider hair loss the most traumatic aspect of chemotherapy, and 8 % would decline chemotherapy because of fear of hair loss. On the basis of the current understanding of the underlying pathobiology, a number of agents have been evaluated in the treatment of this condition. Among the agents that have been evaluated, topical minoxidil was able to reduce the severity or shorten the duration but could not prevent hair loss. The major approach to minimize CIA is by scalp cooling, although most published data on scalp cooling are of poor quality. Because chemotherapy-induced toxicity has been associated with nutritional status, nutritional assessment and support might confer beneficial effects. Several experimental approaches to the development of pharmacological agents are under evaluation including: anti-oxidants, cytokines and growth factors, cell cycle and proliferation modifiers, and inhibitors of apoptosis. The author concluded that at present, no approved pharmacologic treatment of CIA exists. The incidence and severity of the condition are variable and related to the particular chemo-therapeutic protocol. They noted that CIA is mostly reversible, and appropriate hair and scalp care and temporarily wearing a wig may be the most effective coping strategy.
An UpToDate review on “Chemotherapy-induced alopecia “ (Payne, 2013) stated that “Although scalp protection through cooling or tourniquet has been reported to minimize delivery of chemotherapeutic agents to the scalp thereby potentially decreasing the risk of hair loss, case reports of cutaneous metastases or spread in these settings prevent general recommendation for their use. Because chemotherapy-associated hair loss is transient and usually (although not always) completely reversible after cessation of therapy, adequate counseling and psychological support before and during therapy should take precedence over the use of such devices”.
Komen et al (2013) stated that the success of scalp cooling in preventing or reducing CIA is highly variable between patients and chemotherapy regimens. The outcome of hair preservation is often unpredictable and depends on various factors. These investigators performed a structured search of literature published from 1970 to February 2012 for articles that reported on factors influencing the effectiveness of scalp cooling to prevent CIA in patients with cancer. The literature search identified 192 reports, of which 32 studies were considered relevant. Randomized studies on scalp cooling are scarce and there is little information on the determinants of the result. The effectiveness of scalp cooling for hair preservation depends on dose and type of chemotherapy, with less favorable results at higher doses. Temperature seems to be an important determinant. Various studies suggested that a subcutaneous scalp temperature less than 22 °C is required for hair preservation. The authors concluded that the effectiveness of scalp cooling for hair preservation varies by chemotherapy type and dose, and probably by the degree and duration of cooling.
Lemieux et al (2014) noted that alopecia is a side effect of chemotherapies used in breast cancer. Scalp cooling is a technique preventing alopecia, but its use remains controversial. These researchers conducted a survey about knowledge of scalp cooling and interest in conducting a RCT. An invitation was sent to 1,022 participants and a total of 139 individuals responded to the survey. The majority knew about the existence of scalp cooling; 90 % thought that a RCT was needed and would participate. The survey revealed different potential problems associated with the increased chair time, limited space, and safety. The authors concluded that a RCT is needed and that the trial must include evaluation on the impact on health care system resources and safety.
Kadakia et al (2014) stated that conventional chemotherapy leads to multiple adverse mucocutaneous complications (e.g., oral mucositis, alopecia, ocular toxicity, and onycholysis). Limited pharmacologic interventions are available for preventing these clinical problems. These investigators reviewed the role of cryotherapy (regional hypothermia) for alleviating these adverse symptoms. A narrative review was performed, with an emphasis on RCTs. A comprehensive search using PubMed, Ovid, Embase, and Medline was completed. References of all cited articles also were reviewed. Data from the review were composed of articles published between 1970 and May 2013. Available evidence suggested that regional hypothermia decreases the burden of chemotherapy-related oral mucositis, alopecia, ocular toxicity, and onycholysis. The major limitations of studies included the absence of blinded control groups and variable clinical end-points. The authors concluded that regional hypothermia decreased the burden of these 4 chemotherapy-induced complications and was well-tolerated. They stated that more research is needed to (i) determine what subgroups of cancer patients are most likely to respond to different types of regional hypothermia, (ii) the ideal duration of cooling needed, and (iii) further improve the ease of use of the cooling devices.
Shin et al (2015) evaluated the effectiveness of various interventions in the prevention of CIA. They searched PubMed, EMBASE and the Cochrane Library, from June 20, 2013 through August 31, 2013. Two of the authors independently reviewed and selected clinical trials that reported the effectiveness of any intervention for prevention of CIA compared with that of controls. Two authors extracted data independently on dichotomized outcome in terms of CIA occurrence. Relative risks (RRs) and 95 % confidential intervals (CIs) were calculated for effectiveness of CIA prevention by using random-effect or fixed-effect models. Out of 691 articles retrieved, a total of 8 RCTs and 9 controlled clinical trials involving 1,098 participants (616 interventions and 482 controls), were included in the final analyses. Scalp cooling, scalp compression, a combination of cooling and compression, topical minoxidil and panicum miliaceum were used as interventions. The participants were mainly breast cancer patients receiving doxorubicin- or epirubicin-containing chemotherapy. Scalp cooling, which is the most popular preventive method, significantly reduced the risk of CIA (RR = 0.38, 95 % CI: 0.32 to 0.45), whereas topical 2 % minoxidil and other interventions did not significantly reduce the risk of CIA. No serious adverse effects associated with scalp cooling were reported. The authors concluded that these findings suggested that scalp cooling can prevent CIA in patients receiving chemotherapy; however, the long-term safety of scalp cooling should be confirmed in further studies.
|CPT Codes / HCPCS Codes / ICD-10 Codes|
|Information in the [brackets] below has been added for clarification purposes.  Codes requiring a 7th character are represented by "+":|
|ICD-10 codes will become effective as of October 1, 2015 :|
|CPT codes not covered for indications listed in the CPB:|
|97010||Application of a modality to one or more areas; hot or cold packs|
|ICD-10 codes not covered for indications listed in the CPB:|
|C00.0 - G96.9||Malignant neoplasms|
|D00.00 - D09.9||In situ neoplasms|