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Scalp Cooling and Hair Loss

Posted 2/15/2017

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  This topic has been discussed before, but it is getting more attention as evidenced by a brief article in Jama Network yesterday. This coincided with a decision here to begin a three month pilot program to offer appropriate patients up to $500 to purchase a set of cooling caps. We do have a freezer in the Infusion Area, but the logistics are difficult. A woman must begin wearing the cap 30-60 minutes before the infusion and continue doing so for a similar period of time afterwards. The caps must be changed every 30 minutes. This clearly means that there needs to be a companion who is responsible for the fetching and changing; neither the patient nor the infusion nurse can manage this.

  There is a second system that involves being connected electrically to a machine that keeps the cap cold. The same rules about before and after the infusion apply, but no need for the cap exchanges. The trouble for us with this one is that the machines are bulky and would need to be assigned to particular infusion chairs--and we already have a very complicated system of seating that can't accommodate this factor.

    Similar to yesterday's story about context, there are at least a couple of other considerations. The first is that these caps don't work for all chemo drugs. Some, like Adria, are going to overpower the possibility, and alopecia will still be the result. Others, like weekly Taxol, are more likely to be responsive. Secondly, there is minimal but real concern about the possibility of reducing the efficacy of the chemo, specifically that there won't be delivery of the drug to the scalp. Scalp mets are rare but possible, and it could be years before they occur.

  With all that in mind, here is the start of the article and a link to read more:

Do the Data on Scalp Cooling for Patients With Breast Cancer Warrant Broad Adoption?

Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial

Julie Nangia, MD, Tao Wang, PhD, Cynthia Osborne, MD, et al

Importance Chemotherapy may induce alopecia. Although scalp cooling devices have been used to prevent this alopecia, efficacy has not been assessed in a randomized clinical trial.

Objectives To assess whether a scalp cooling device is effective at reducing chemotherapy-induced alopecia and to assess adverse treatment effects.

Design, Setting, and Participants Multicenter randomized clinical trial of women with breast cancer undergoing chemotherapy. Patients were enrolled from December 9, 2013, to September 30, 2016. One interim analysis was planned to allow the study to stop early for efficacy. Data reported are from the interim analysis. This study was conducted at 7 sites in the United States, and 182 women with breast cancer requiring chemotherapy were enrolled and randomized.

Interventions Participants were randomized to scalp cooling (n = 119) or control (n = 63). Scalp cooling was done using a scalp cooling device.

Main Outcomes and Measures The primary efficacy end points were successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade 0 [no hair loss] or grade 1 [<50% hair loss not requiring a wig] were considered to have hair preservation) at the end of 4 cycles of chemotherapy by a clinician unaware of treatment assignment, and device safety. Secondary end points included wig use and scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30, Hospital Anxiety and Depression Scale, and a summary scale of the Body Image Scale.

Results At the time of the interim analysis, 142 participants were evaluable. The mean (SD) age of the patients was 52.6 (10.1) years; 36% (n = 51) received anthracycline-based chemotherapy and 64% (n = 91) received taxane-based chemotherapy. Successful hair preservation was found in 48 of 95 women with cooling (50.5%; 95% CI, 40.7%-60.4%) compared with 0 of 47 women in the control group (0%; 95% CI, 0%-7.6%) (success rate difference, 50.5%; 95% CI, 40.5%-60.6%). Because the 1-tailed P value from the Fisher exact test was <.001, which crossed the superiority boundary (P = .0061), the data and safety monitoring board recommended study termination on September 26, 2016. There were no statistically significant differences in changes in any of the scales of quality of life from baseline to chemotherapy cycle 4 among the scalp cooling and control groups. Only adverse events related to device use were collected; 54 adverse events were reported in the cooling group, all grades 1 and 2. There were no serious adverse device events.

Conclusions and Relevance Among women with stage I to II breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have less than 50% hair loss after the fourth chemotherapy cycle compared with those who received no scalp cooling. Further research is needed to assess longer-term efficacy and adverse effects.

Read more: http://jamanetwork.com/journals/jamaoncology/fullarticle/2603438

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