U.S. Oncology Research—one of the largest community-based cancer research programs in the nation—and Baylor College of Medicine recently have launched a clinical trial to study a scalp cooling system designed to prevent chemotherapy-induced hair loss (alopecia). To date, 15 patients have been enrolled, and the study now is available at three U.S. Oncology Research sites.

Hair loss from chemotherapy can be one of the most distressing and troublesome side effects cancer patients face, often impacting their body image, sexuality and overall well-being. Patients who lose their hair also lose their privacy as a cancer patient, as hair loss commonly is associated with cancer treatment. Now, there may be a way to stop or greatly reduce the hair loss that can occur with certain chemotherapy treatments.

Cooling the scalp during chemotherapy causes the blood vessels in the scalp to constrict. Preliminary observation has shown this may reduce or prevent otherwise inevitable total hair loss caused by some chemotherapy regimens. By keeping the scalp at a constant cool temperature before, during and after infusion of chemotherapy drugs, damage to the cells in the hair root may be minimized. The U.S. Oncology Research study Scalp Cooling Alopecia Prevention Trial(SCALP) will examine the Orbis Paxman Hair Loss Prevention System. The goal is to determine the safety and effectiveness of the system in reducing alopecia in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

“Several preliminary studies have demonstrated the effectiveness of the Paxman Scalp Cooling System for some patients in preventing hair loss that often occurs as a result of chemotherapy,” said Cynthia Osborne, M.D., medical oncologist, Texas Oncology-Baylor Charles A. Sammons Cancer Center, and Principal Investigator for this study at U.S. Oncology Research. “This clinical trial will provide the foundation for us to build credible evidence-based data, allowing us to make better decisions for our patients about whether this is a viable non-drug intervention for those who are concerned about hair loss during treatment.”

The Paxman Scalp Cooling System utilizes a soft lightweight silicone cap which is placed on the patient’s head. The “cold cap” is connected to a small compact refrigeration system which lowers the scalp temperature by circulating a special coolant through the cap. The cap maintains the scalp at a constant temperature throughout the treatment period. It is placed on the patient about a half-hour before the chemotherapy is administered and continues to be worn for approximately 90 minutes after the infusion is complete, depending on the type of drugs given.

“The cooling system is used extensively in several European countries, as well as Australia and Canada,” said Julie Nangia, M.D., assistant professor, Lester & Sue Smith Breast Center, Baylor College of Medicine. “The observational results from these countries indicate that anywhere between 50% and 75% of patients keep their hair when the system is used. These are promising outcomes, as total hair loss is expected with these selected chemotherapy drugs.”

Approximately 50 participants are being recruited for the trial at three participating U.S. Oncology Research sites: Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, led by Cynthia Osborne, M.D.; Texas Oncology-Memorial City, Houston, Texas, led by Frankie Ann Holmes, M.D.; and Hematology-Oncology Associates of Northern New Jersey, Pa., Morristown, N.J., led by Steven Papish, M.D., F.A.C.P.