How Safe and Effective Is Scalp Cooling for Chemotherapy-Induced Alopecia?

August 08, 2017 by Elisa Becze BA, ELS, Editor

Chemotherapy-induced alopecia (CIA) has been reported by 77% of patients as the most-feared side effect of cancer treatment. In fact, as many as 10% of women say they would consider refusing chemotherapy or choosing a less effective treatment to avoid losing their hair.

And although CIA is usually transient, it can become persistent or chronic in some patients.

Scalp cooling has been used since the 1970s, and the first systematic review on its use was published in 2005. It’s used routinely in countries such as the United Kingdom, France, the Netherlands, and Canada to limit CIA. However, the United States has been slower to adopt its regular use because of lack of consensus on efficacy and safety.

In their article in the April 2017 issue of the Clinical Journal of Oncology Nursing (https://cjon.ons.org/cjon/21/2-0/scalp-cooling-literature-review-efficacy-safety-and-tolerability-chemotherapy-induced), Ross and Fischer-Cartlidge analyzed the literature to help determine whether scalp cooling was effective, safe, and tolerable in preventing CIA.

Scalp Cooling for CIA

Ross and Fischer-Cartlidge explained that scalp cooling’s mechanism of action (https://cjon.ons.org/cjon/21/2-0/scalp-cooling-literature-review-efficacy-safety-and-tolerability-chemotherapy-induced) is believed to be twofold:

Vasoconstriction that decreases blood flow to the hair follicles and limits the uptake of cytotoxic agents
Decreased follicle metabolism, which makes follicles less susceptible to chemotherapy damage.

However, opponents of CIA have had two correlated arguments, although Ross and Fischer-Cartlidge noted that the concerns are unsupported:

Potential risk of scalp metastasis
Possibility of secondary seeding to other organs from dormant cancer cells in the scalp not killed by chemotherapy.

Clinical trials are underway for the marketing approval of two scalp cooling systems: DigniCap and Paxman. DigniCap received U.S. Food and Drug Administration marketing approval in 2015, and Paxman received clearance in April 2017.

Putting Evidence Into Practice

Ross and Fischer-Cartlidge took their findings (https://cjon.ons.org/cjon/21/2-0/scalp-cooling-literature-review-efficacy-safety-and-tolerability-chemotherapy-induced) and made recommendations for their institution to revise its practice regarding scalp cooling. Previously, it had been discouraged because of concerns about efficacy and safety, but given the comprehensive review of data, clinicians began presenting it as an option for patients receiving chemotherapy with a high incidence of alopecia.

“Evidence-based practice calls for healthcare providers to move away from ‘how we have always done it’ to a practice deeply rooted in evidence, which oncology nurses have done for years at the forefront of advances in supportive care,” Ross and Fischer-Cartlidge wrote. Nurses should be empowered to understand data on scalp cooling so they can advocate for and discuss it with their patients.

For more information on scalp cooling for CIA, refer to the full article by Ross and Fischer-Cartlidge (https://cjon.ons.org/cjon/21/2-0/scalp-cooling-literature-review-efficacy-safety-and-tolerability-chemotherapy-induced).

Evaluating the Data

Efficacy: The comparative trials that Ross and Fischer-Cartlidge found (https://cjon.ons.org/cjon/21/2-0/scalp-cooling-literature-review-efficacy-safety-and-tolerability-chemotherapy-induced) showed successful hair preservation in 34%–93% of study cohorts that used scalp cooling. Control cohorts had only 0%–26% hair preservation.

A large, single-arm study (the largest cohort reported in the literature) showed that of 1,411 patients who used scalp cooling, 50% did not use a head covering when attending their last treatment. The study is ongoing and the researchers plan to report more long-term data in the future.

Rates of hair preservation in four systematic reviews ranged from 10%–100%, with most clustering around 50%.

Safety: Retrospective and systemic analyses show a consistent, low incidence of scalp metastasis, ranging from 0.4%–1.1% in patients who use scalp cooling versus 0.3%–3% in patients who did not. Follow-up periods ranged from two to nine years.

Ross and Fischer-Cartlidge noted (https://cjon.ons.org/cjon/21/2-0/scalp-cooling-literature-review-efficacy-safety-and-tolerability-chemotherapy-induced) that scalp metastases “are rarely a unique site of disease, generally do not prove to be lethal, and do not pose the same threat to survival as visceral or central nervous system involvement,” so secondary seeding may be the larger of the two concerns. However, a retrospective study of 1,370 patients followed for a minimum of six years found no difference in overall survival between patients who did and did not use scalp cooling.

They said that patients with locally advanced disease have higher rates of recurrence, but overall survival statistics analysis showed no greater risk of death or difference in overall survival in patients with stage III disease who used scalp cooling.

Ross and Fischer-Cartlidge did remark that scalp cooling is contraindicated in patients with known hematologic malignancies because of case reports of scalp metastases and a lack of safety data. Other contraindications include:

Cold sensitivity
Cold agglutinin disease
Cryoglobulinemia
Cryofibrinogenemia.

Tolerability: A mixed cohort study reported that 70% of patients felt “very well” or “rather well” while using scalp cooling. Most experienced only mild side effects (e.g., headache, cold sensation) that did not result in treatment discontinuation. One study reported only a 3% discontinuation rate among 1,528 participants, but another found a discontinuation rate of 12.6% in a metastatic cohort, although Ross and Fischer-Cartlidge noted (https://cjon.ons.org/cjon/21/2-0/scalp-cooling-literature-review-efficacy-safety-and-tolerability-chemotherapy-induced) that it could be attributed to the long-term nature of metastatic treatment in general.

This monthly feature offers readers a concise recap of full-length articles published in the Clinical Journal of Oncology Nursing (CJON) or Oncology Nursing Forum. This edition summarizes “Scalp Cooling: A Literature Review of Efficacy, Safety, and Tolerability for Chemotherapy-Induced Alopecia,” by Mikel Ross, BSN, RN, OCN^®, CBCN^®, and Erica Fischer-Cartlidge, MSN, CNS, CBCN^®, AOCNS^®, which was published in the April 2017 issue of CJON. Questions regarding the information presented in this article should be directed to the CJON editor at CJONEditor@ons.org. Photocopying of this article for educational purposes and group discussion is permitted.

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