A scalp-cooling system helped prevent hair loss in women with breast cancer undergoing chemotherapy, researchers said today at the San Antonio Breast Cancer Symposium.
“Scalp cooling devices are highly effective and should become available to women with breast cancer receiving chemotherapy,” lead author Dr. Julie Rani Nangia of Baylor College of Medicine in Houston, Texas, said during a media briefing.
Scalp-cooling technology lowers the temperature of the scalp, which reduces blood flow to hair follicles and has been shown in other studies to reduce hair loss in cancer patients undergoing chemotherapy, she explained.
The Scalp Cooling Alopecia Prevention (SCALP) Trial enrolled 235 women at seven U.S. medical centers. The women had stage 1 or 2 breast cancer and were scheduled to receive at least four rounds of chemo with anthracycline or taxane, which are known to cause hair loss.
Patients were randomly assigned to either scalp-cooling with the still-experimental Orbis Paxman Hair Loss Prevention System (OPHLPS) or no scalp cooling.
The system features a “cold cap” that is fitted to a patient’s head during chemotherapy. Cooling was done 30 minutes before, during, and for 90 minutes after chemotherapy sessions. (See a picture of the cooling cap here.
Based on the superior results with the scalp-cooling device, the research team’s safety monitors decided to stop the study and release the data, Nangia said.
At that point, 95 patients in the cooling group and 47 patients in the non-cooling group had completed four cycles of chemotherapy. Forty-eight patients in the cooling group (50.5 percent) retained their hair, compared with none of the patients in the no-cooling group.
Side effects were mild and included headache, nausea and dizziness, Nangia reported. Most of the patients rated the cooling device as “reasonably comfortable and very few found the scalp cooling device uncomfortable,” she said.
Paxman, which makes the OPHLPS system, is now seeking clearance from the U.S. Food and Drug Administration to market the device. Last December, the FDA cleared a scalp-cooling system made by Dignitana Inc, called DigniCap.
Nangia said scalp-cooling technology has been used for other solid-tumor cancer types in other countries, although it is not appropriate for patients with blood cancers.
The women in the SCALP trial will be followed for five years to monitor overall survival, recurrence of cancer and potential metastasis to the scalp.
Nangia noted that scalp cooling technology has been slower to catch on in the U.S. than Europe, partly due to concerns about the potential for cancer spreading to the scalp.
But briefing moderator Dr. Kent Osborne, co-director of the San Antonio Breast Cancer Symposium and also from Baylor College of Medicine, said, “We have tons of data from different trials looking at the site of first recurrence in patients with stage 1 or 2 breast cancer and I don’t think we found a single patient that recurred in the scalp only, ever.”
“Yes, scalp metastases happen but they always happen in the face of metastasis everywhere else in the body so we are quite certain given that and the data from some of the European trials that that’s not going to be an issue,” Osborne said.