DigniCap®

Hair Loss is No Longer Inevitable ~ FDA Approved System!

The DigniCap® Scalp Cooling System

FDA-cleared Dignicap System at Piedmont Cancer Institute

PCI offers DigniCap, an FDA-cleared scalp cooling treatment to minimize chemotherapy-induced hair loss in patients with solid tumor cancers.

Hair loss is a well-documented side effect of many chemotherapy drugs. Chemotherapy induced hair loss can be significantly reduced in many cases. The DigniCap® Scalp Cooling System offers you the possibility to minimize hair loss while receiving certain chemotherapy treatments for cancer from solid tumors. This may include breast cancer, ovarian cancer, prostate cancer and other solid tumor cancers.

For over a decade DigniCap has successfully helped thousands of patients outside the United States. Now, with FDA clearance, PCI is proud to offer DigniCap as a treatment option for our patients.

"Having the option of using DigniCap® to reduce their risk of chemotherapy-induced hair loss can give them a sense of control during a time when most things are out of their control. The cold caps we used to offer came with the added stress of maintaining constant temperatures and the difficulties of ensuring the right fit. Clinicians at the Piedmont Cancer Institute are excited by the opportunity to use a safe, effective, and easy-to-use scalp cooling technology that will allow our patients to undergo treatment with more confidence, privacy, and preserve some sense of normalcy during a very difficult time."

How does scalp cooling work?

FDA-cleared Dignicap System at Piedmont Cancer Institute

Some chemotherapy drugs can damage your hair cells. Cooling of the scalp is a proven approach to reduce chemotherapy-induced hair loss that has been used successfully by tens of thousands of patients worldwide.

The reduced temperature results in a reduced blood flow to the scalp area so that less chemotherapy reaches the hair cells. Hair cells are therefore not exposed to the full dose of chemotherapy and may be able to survive the chemotherapy treatment. In addition, cellular metabolism within the hair cells is slowed down. As a result, hair is less likely to fall out.

Prior to DigniCap , some patients used manual cold caps kept in freezers or chilled with dry ice. Patients would have to change the manual caps every 30 minutes to ensure the scalp would remain chilled.

Who can use DigniCap?

FDA-cleared Dignicap System at Piedmont Cancer Institute

The DigniCap Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced in patients with solid tumors.

Please note that scalp cooling is effective with many chemotherapy drugs, but not all. Your clinician can tell you if scalp cooling is compatible with your treatment.

Is scalp cooling covered by insurance?

FDA-cleared Dignicap System at Piedmont Cancer Institute

Scalp cooling treatments do not yet have universal insurance coverage, but your treatment costs may be partially reimbursed, depending on your provider, plan and coverage. For more information on insurance reimbursement for DigniCap, visit the DigniCap website.

Additionally, you may qualify for financial assistance from HairToStay, a national non-profit that provides subsidies to scalp cooling patients with financial need. Visit www.hairtostay.org for more information.

Clinical Research Summary

FDA-cleared Dignicap System at Piedmont Cancer Institute

The DigniCap scalp cooling system was studied in women with breast cancer at some of the most prestigious medical centers in the nation. In the pivotal trial it was concluded that the scalp cooling system, DigniCap, prevented hair loss in 66.3% of patients with breast cancer receiving adjuvant chemotherapy compared to control where all experienced significant hair loss. Treatment was well tolerated with no scalp metastases observed. The DigniCap scalp cooling system was found to be highly effective in reducing chemotherapy-induced alopecia.

The DigniCap Scalp Cooling System was cleared for use in the United States by the FDA on 12/8/2015 for female breast cancer patients being treated with chemotherapy, the first such device to receive clearance. The FDA expanded the clinical indications for DigniCap on 7/3/17 to now include men and women with solid tumors.

Where do I learn more?

FDA-cleared Dignicap System at Piedmont Cancer Institute

To learn more about scalp cooling with DigniCap at PCI call to schedule a convenient appointment.

For more information on scalp cooling visit www.dignicap.com.

Trevor M. Feinstein, MD

"Scalp cooling systems are changing medical oncology," said Dr. Trevor Feinstein, a hematologist/ oncologist with the Piedmont Cancer Institute.

"With use of a scalp cooling system, about two out of three women treated with a non-anthracyline based chemotherapy will have minimal hair loss.

Piedmont Cancer Institute physicians are excited to be the first site in Georgia to offer the DigniCap, the first FDA-cleared scalp cooling system. Previously, we had been using cold cap systems which require a large freezer and changing of the cap every 30 minutes. We have found the cold cap systems to be cumbersome and are enthusiastic about the transition to the DigniCap Scalp Cooling System."

Ha Tran, MD

"We are thrilled to be the first oncology practice in the state of Georgia to offer the DigniCap® Scalp Cooling System to our patients. When patients receive a new diagnosis of cancer and embark on complicated treatment plans, their lives can become overwhelming and chaotic," said Dr. Ha Tran, a hematologist/ oncologist with the Piedmont Cancer Institute.