



Two articles and commentaries in this week’s issues of the Journal of the American Medical Association (JAMA) and its companion JAMA Oncology present new information about an old approach to preventing hair loss, along with some new thoughts and suggestions as to what this may mean longer term. And along with the new thoughts are some cautionary comments that women who hear about this treatment need to know as they make their decisions, and anticipate the benefits of trying to prevent hair loss.

In brief, there were two studies reported in JAMA. In one, women being treated at one of seven major cancer centers here in the United States were randomly assigned to have their scalps “cooled” using a cap type of device applied before, during, and after the chemotherapy session. After four cycles of chemotherapy, the investigators found half of the women who used the cold cap maintained what was considered an adequate amount of hair. Meanwhile, none of the women in the control group –who did not use the cold cap—avoided hair loss. The results were so good the study was stopped early.

In the second study—also completed at a number of highly-regarded cancer centers here in the United States—106 women receiving chemotherapy for breast cancer used the cold cap while a smaller group of 16 similar patients were treated without a cold cap. In this study, women who used the cold cap were asked to evaluate their assessment of hair loss, and photos were used to verify their determination. About 2/3 of the women who used the cold cap had less than 50 % hair loss. All of the women in the control group lost their hair.

Sounds like a done deal, but as is frequently the case, there’s more to the story. Besides hair loss, investigators asked about other issues, in particular, about overall quality of life. And those assessments yielded interesting—and conflicting—results.

In the second study, three of five quality of life measures were better among those using the cooling cap.  Side effects were considered mild to modest in both studies, with a small number experiencing headache and/or discontinued treatment because of the cold sensation itself. Scalp pain was another commonly reported side effect. But in the first study, maintaining one’s hair was not found to improve quality of life, a somewhat surprising finding called out by an accompanying editorial. Perhaps, as noted, the absence of a difference in quality of life between the group that received the cold cap and those that did not had to do with the other, obvious and overwhelming factor that faced with a diagnosis of breast cancer and intensive treatment, the impact of keeping one’s hair may have had an impact, but not one that was great enough compared to other factors associated with diagnosis and treatment.

So here’s we are so far: Cooling the scalp appears to prevent hair loss in at least half and maybe more of the women receiving chemotherapy as part of their treatment for breast cancer. But overall there’s not much effect on quality of life. But even that is not the whole story, because there are some important considerations that may not be well appreciated in the various media stories that are likely to show up as a result of these reports.

First, let’s understand that cooling the scalp is not a new idea. Literally decades ago there was interest in this approach to reduce hair loss. What is new is the technology: it is sophisticated, standardized and appears to be effective. The Food and Drug Administration has actually fairly recently approved one of these devices for more general use. That’s a long way from putting a cold cap from the refrigerator or one packed with ice on the head during treatment, which is indeed what some oncologists used to do. As I said, that was a long time ago. Fortunately, medicine has made some advances over the years.

But with those advances comes some new issues. The treatment is not simple, nor is it quick. In one study, the device was applied 30 minutes before, then during, and then 90-120 minutes after chemotherapy was completed. That’s a lot of time for the patient, and a lot of attention from medical staff. In the other study, once again the device was applied 30 minutes before, during, and 90 minutes after infusion was completed.

Also keep in mind that there are several different types of chemotherapy regimens that are used to treat breast cancer, including drugs called taxanes (which cause hair loss) and anthracyclines (drugs which are notorious for causing rapid and virtually complete hair loss). And guess what: in one of the studies—the one with the higher success rate—none of the women received anthracyclines.

That’s important because it relates to how we set expectations for women in this situation. It means that if an anthracycline-type of drug is used, the results may not be what a woman could expect based on these studies, and how they’re reported. Treatment for breast cancer is difficult enough. Having hopes dashed just adds to the difficulty. And if media accounts do not include these important caveats, it’s left to health professionals to explain some rather harsh realities when they talk to their patients about the potential outcomes, including the fact that in about half the women the results probably won’t be as good as anticipated.

There were also some unexplained differences in the outcomes for different women at different treatment centers. This was most notable in the first study, where in some centers there were excellent results (69% of the women did not lose a significant amount of hair) while at one center 13% of the women were able to keep much of their hair, and at still one other, none of the women, 0%, were able to prevent significant hair loss. The authors suggest this may have been due to experience of the operators using the device, fitting it properly, the type of chemotherapy or factors specific to the patient.

Then there is the important question of whether there is a long term downside to using this approach. One of the concerns that has been a barrier to widespread adoption of scalp cooling has been the question of whether the same mechanism that prevents hair from falling out could lead to creating a sanctuary for cancer cells that may reappear years or even decades later. Why? Well, because the reason that the hair doesn’t fall out is because the chemotherapy doesn’t get to it. If chemotherapy doesn’t get there, then could cancer cells hide and reappear at a later date?

When you talk with older oncologists, they will tell you recurrence in the scalp was not unheard of. The authors of these current reports provide more recent information—including European experience, where cold caps apparently have more widespread acceptance—saying that this is not a concern. That’s somewhat comforting, but if there’s one thing we’ve learned about cancer, it’s that trying to predict its behavior is dangerous business. Breast cancer can sometimes act in strange ways, recurring many years later. Time will tell if this is in fact a legitimate issue. I think it is fair to say that there is expert opinion that these concerns are overblown, however the women in these studies will be followed over time to answer that question.

So where does this leave us?

Despite the fact that different centers saw different results, and notwithstanding the as-yet unfounded concern that cooling may harbor errant cancer cells that can lurk in the scalp, the authors of the research papers as well as to accompanying editorial and commentary in the same two journals all point towards more widespread adoption of this technology in an effort to reduce chemotherapy associated hair loss, with the potential benefit of reducing the anxiety that comes with treatment for breast cancer.

Cost may be a barrier, with estimates ranging from $1500 to $3000 for a course of scalp-cooling as part of a chemotherapy program. And this is likely not going to be covered by insurance, since it is considered “cosmetic,” and not intrinsic to the treatment for a particular disease. It is certainly possible that may change with time, however today coverage is uncertain at best.

As with many things that change in medical care, cooling caps are likely to engender further discussion. There are things we know about them, and there are always things we don’t know that become evident with time as more people use the technology. And then there are the “old timers” who may be reluctant to change the way they do things, while some “new timers” may find that purchasing and using the machines may simply be too expensive and time consuming.

Ultimately, it’s up to women and their health professionals to make their own decisions. And inevitably word of mouth will spread quickly in the patient/consumer community. Just remember that anecdotes are not evidence, and right now the evidence suggests that using a cold cap given the 50-50 chance it may help you avoid using a wig, cap, bandana or other means to compensate for hair loss may be something you would want to consider when faced with the decision.