Recently Opened Study: DigniCap Cold Cap in Early Stage Breast Cancer

The Weill Cornell Breast Center has recently opened a new cold cap research study. The study is for women with early stage breast cancer who will be receiving chemotherapy that has a high probability of causing them to lose their hair.

The study sponsor is Dignitana, and the principal investigator at Weill Cornell is Dr. Tessa Cigler. For more information about the study, please call Marta Cobham, RN at (212) 821-0780 or e-mail Marta at mac2034@med.cornell.edu.

Key Eligibility

Women age 18 and older
Stage I or II breast cancer
Planned course of chemotherapy in the adjuvant or neoadjuvant setting
Plan to complete chemotherapy within 6 months
Detailed eligibility reviewed when you contact the study team

Study Details

The purpose of the study is to evaluate the safety and effectiveness of an experimental medical device called the DigniCap System, a cooling system designed to help prevent chemotherapy-induced hair loss. Scalp cooling works by constricting the small blood vessels around the hair follicles so that less chemotherapy reaches the follicle. Hair cells are therefore not exposed to the full dose of chemotherapy and survive the chemotherapy treatment. As a result, hair is less likely to be lost.

Study participants will wear the DigniCap cooling cap on their head for 30 minutes before starting a chemotherapy treatment, during the chemotherapy infusion and for up to 90 minutes after the infusion is finished. Participants will wear the cap for three to six hours during each chemotherapy treatment, depending on the chemotherapy regimen.

Participants will be photographed as part of the research study to assess hair loss. Participants will be seen 4 weeks after their final chemotherapy cycle, and then 3 and 6 months later for follow-up.

Click here to view all current clinical trials at the Breast Center.

 

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