Scalp Cooling for Breast and Ovarian Cancer Patients

The purpose of this study is to determine how well scalp cooling works in a diverse population of patients undergoing chemotherapy for breast or ovarian cancer. The Paxman scalp cooling system is a United States (U.S.) Food and Drug Administration (FDA) approved device that has been shown to prevent hair loss from chemotherapy. Scalp cooling may cost up to $2400 and is an out-of-pocket expense that is not covered by most insurances. We received a grant from the Bears Cares Foundation to provide free scalp cooling for patients who cannot afford it. We want to see how well the Paxman scalp cooling system works in a diverse population.

If you agree to participate in this study, your participation may last as long you wish to receive scalp cooling with your chemotherapy. You will be asked to complete a questionnaire before starting (at baseline), prior to each chemotherapy visit, and at follow up visits between 4-8 weeks and 16-26 weeks. You do not need to participate in this study to receive free scalp cooling.

During these visits, you will be asked to rate how well you think the scalp cooling is working and have pictures of your scalp taken. The pictures will be uploaded onto your electronic medical record.

There are risks to you for participating in this study. In this study, there are risks from using the scalp cooling device. You may feel cold, have a headache, develop chills, lightheadedness/dizziness, neck pain, and/or nausea. Scalp cooling will add time to your chemotherapy visit. Scalp cooling will begin 30 minutes prior to your chemotherapy infusion, and end 90 minutes after your chemotherapy is finished.

You may not directly benefit from taking part in this study, but we hope that knowledge gained from this study may benefit others with breast or ovarian cancer in the future.

You have the option of not participating in this study and can still get free scalp cooling.

In order to participate you must meet the following criteria:

• Are at least 18 years of age.
• Have a confirmed diagnosis of ovarian or breast cancer who is undergoing chemotherapy.
• Have any hair type, including Type 3 (curly) and 4 Type (coily) hair.
• Have reported financial toxicity with scalp cooling.

You will be excluded from the study if any of the following criteria apply to you:

• Are less than 18 years of age.
• Use hair extensions without plans to remove.
• Plan to chemically straighten hair.
• Have specific concurrent illnesses.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.