Randomized Trial Demonstrates Benefit of Scalp-Cooling in Prevention of Chemotherapy-Induced Hair Loss



A scalp-cooling device was found safe and effective in preventing chemotherapy-induced hair loss in women undergoing adjuvant treatment for breast cancer in an interim analysis of the first prospective, randomized trial of a modern scalp-cooling system. The study was presented at the 2016 San Antonio Breast Cancer Symposium.1

The scalp-cooling system prevented hair loss in 50.5% of patients, compared with no patients who were not randomized to the scalp-cooling system (P < .0001).


Chemotherapy-induced hair loss has a devastating effect on a woman’s psyche and body image…. Scalp-cooling devices are highly effective [in preventing hair loss] and should be available for breast cancer patients.
— Julie R. Nangia, MD

“Chemotherapy-induced hair loss has a devastating effect on a woman’s psyche and body image. It is one of the most distressing side effects of chemotherapy. Scalp-cooling devices are highly effective [in preventing hair loss] and should be available for breast cancer patients,” said lead author Julie R. Nangia, MD, Assistant Professor of Medicine at the Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston. “We need further studies on the impact of chemotherapy-induced alopecia on quality of life, and we also need to explore this technology for hair loss associated with chemotherapy for other types of tumors.” She noted that scalp-cooling systems are used in Europe, and interest in these systems is high in the United States.

The device used in the trial was the Orbis Paxman Hair Loss Prevention System, now known as the Paxman Scalp Cooling System. Paxman Coolers Ltd has filed for U.S. Food and Drug Administration (FDA) clearance for this system. If the device is cleared for marketing, it will compete with the DigniCap Cooling System made by Dignitana, Inc, which was cleared by the FDA in 2015.

Study Details

From December 2013 to September 2016, the study enrolled 235 women with stage I or II breast cancer slated for at least 4 cycles of anthracycline-based or taxane-based chemotherapy at 7 different sites in the United States. Participants were randomly assigned 2:1 to receive scalp-cooling or not. Those assigned to the scalp-cooling treatment used the system 30 minutes before, during, and 30 minutes after chemotherapy sessions.

Hair loss was graded according to Common Terminology Criteria for Adverse Events, version 4.0, as grade 0 (no hair loss), grade 1 (hair loss up to 50% of normal, no wig required), or grade 2 (hair loss > 50% of normal, wig required).

Patients also reported their degree of comfort with the device, ranging from very uncomfortable to very comfortable. Quality of life was evaluated with the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire–Core 30 (EORTC QLQ-C30), Hospital Anxiety Depression Scale, and Body Image Scale.

“The present trial is distinguished from other trials of scalp-cooling by including quality-of-life assessments,” Dr. Nangia noted.

The interim analysis presented by Dr. Nangia was based on 142 participants (95 randomized to the device, 47 to control) who were evaluable for results. The study was stopped by the Data Safety Monitoring Board due to superior results in the group assigned to scalp-cooling.

Key Data

For the primary outcome of hair preservation, 50.5% of patients using the scalp-cooling system retained their hair compared with 0% in the control group, which was highly statistically significant (P < .0001).

The most common adverse event was headache, which was reported in 11.9% of patients after cycle 1 of chemotherapy, down to 6.5% associated with cycle 4. Very few other adverse events were reported; they included headache, nausea, and dizziness, and all were grade 1 or 2. On the comfort scale, about 85% rated the device as very comfortable, reasonably comfortable, or comfortable for all 4 cycles of chemotherapy. The scalp-cooling device had no detrimental impact on quality of life.

Dr. Nangia noted that this trial and other studies of scalp-cooling devices found that scalp-cooling was more effective with taxane-based chemotherapy than with anthracycline-based therapy: 65% of patients treated with taxane-based chemotherapy retained their hair vs 22% in the anthracycline-treated group (P < .0001). “The device was especially successful with paclitaxel,” Dr. Nangia commented.

Preventing Hair Loss in Chemotherapy Recipients

  • The first-ever randomized trial of a scalp-cooling device found that it prevented chemotherapy-induced hair loss in 50% of patients with early breast cancer undergoing adjuvant or neoadjuvant chemotherapy.
  • The device was safe over the short term, with headache as the most common side effect.
  • Patients will be followed for 5 additional years to determine long-term safety.

Concern had been raised about the potential for scalp-cooling systems to cause scalp metastasis. The safety of scalp-cooling systems was demonstrated in previous European trials, Dr. Nangia said, after which the FDA allowed the present study to commence. Participants will be followed for 5 years after the study ends for time to first disease recurrence, overall survival, site of first recurrence, and incidence of isolated scalp metastasis.

Dr. Nangia noted that the scalp-cooling system adds another hour to the patient’s stay at the clinic. She and her coauthors recommend sulfate shampoo and “lots of conditioner” for their patients. “We discourage hair coloring,” she added.

“We want to get this device covered by insurance, and we will need to demonstrate safety and improved alopecia-specific quality of life,” Dr. Nangia said.

Additional Comments

Speaking at a press conference, Marisa Weiss, MD, of Breastcancer.org, said, “Hair loss is an obstacle for women undergoing chemotherapy. Studies show that women dread hair loss more than mastectomies. We hope that this device will encourage more women to accept chemotherapy.”

Dr. Weiss pointed out that the cold cap needs to be appropriately fitted with a proper seal, and this requires a learning curve. “The fit of the cap is key. If there are any gaps, the patient will experience hair loss.”

Press conference moderator C. Kent Osborne, MD, Director of the Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine, and a coauthor of the study, said the safety of scalp-cooling is reassuring. “Concern was raised about scalp metastasis. We now have tons of data from different trials, and there is not one patient who had a recurrence in the scalp only. Scalp metastasis has only been seen in the context of other metastasis,” Dr. Osborne noted.

Preventing Hair Loss in Chemotherapy Recipients

  • The first-ever randomized trial of a scalp-cooling device found that it prevented chemotherapy-induced hair loss in 50% of patients with early breast cancer undergoing adjuvant or neoadjuvant chemotherapy.
  • The device was safe over the short term, with headache as the most common side effect.
  • Patients will be followed for 5 additional years to determine long-term safety.

At the formal presentation during the symposium, Steven Vogl, MD, an oncologist in private practice affiliated with Montefiore Medical Center in New York, took issue with the study design. He said that the criterion of four chemotherapy cycles is too short to determine efficacy.

“In other studies of scalp-cooling devices, [chemotherapy-induced alopecia] caught up with [the benefit] after successive cycles. So although more patients retained their hair, they just became bald later,” Dr. Vogl said. He suggested that the study should assess hair loss after 8 cycles of chemotherapy, which is how taxanes are typically delivered.

Dr. Nangia said a final analysis will be forthcoming, but she expected the efficacy to hold up over time. “Some decrease in efficacy might be seen in women treated with taxanes followed by anthracyclines,” she said. ■

Disclosure: The study was funded by Paxman Coolers Ltd.

Reference

1. Nangia R, Wang T, Niravath P, et al: Scalp cooling alopecia prevention trial (SCALP) for patients with early breast cancer. 2016 San Antonio Breast Cancer Symposium. Abstract S5-02. Presented December 9, 2016.

 



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