Clinical Performance, Efficacy and Safety of the DigniCap System, a Scalp Hypothermia System, in Preventing Chemotherapy Induced Alopecia in Patients with Early Stage Breast Cancer

Study Status

Open to Enrollment

Study Description

This research 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 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.

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Disease Status and/or Stage

Stage I or II Breast Cancer


Dignitana AB

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

Principal Investigator

Tessa Cigler, MD


Protocol ID


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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