Clinical trial: NCT01986140
Section: Participant's Rights
Subsections: Subject'S Rights

Your signature on this consent form means that you have received the information about this study and that you agree to volunteer for this research study. You will be given a copy of this signed form to keep. You are not giving up any of your rights by signing this form. Even after you have signed this form, you may change your mind at any time. Please contact the study staff if you decide to stop taking part in this study. If you choose not to take part in the research or if you decide to stop taking part later, your benefits and services will stay the same as before this study was discussed with you. You will not lose these benefits, services, or rights. The investigator, JULIE RANI NANGIA, and/or someone he/she appoints in his/her place will try to answer all of your questions. If you have questions or concerns at any time, or if you need to report an injury related to the research, you may speak with a member of the study staff: JULIE RANI NANGIA at 713-798-1999 during the day and after hours. Members of the Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals (IRB)
can also answer your questions and concerns about your rights as a research subject. The IRB office number is (713) 798-6970. Call the IRB office if you would like to speak to a person independent of the investigator and research staff for complaints about the research, if you cannot reach the research staff, or if you wish to talk to someone other than the research staff.  
Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals HIPAA Compliant  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S.  
Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. The National Institutes of Health (NIH) and the National Cancer Institute (NCI) may have access to your records for research purposes. Coded information may be provided to the NIH/NCI such as your Patient ID, your Zip code, your country and your birth date (month and year). However, in the event of an audit, the NIH/NCI might have access to more information that is part of your research record." What will happen at the end of the study? The study results will be submitted for product approval to the United States Food and Drug Administration and to the governing agency of other countries . You can visit the Sponsor's website to request a copy of the final report after it has been published. After you complete the study, you will be followed by your doctor per standard of care. In the event of injury resulting from this research, the Harris County Hospital District is not able to offer financial compensation nor to absorb the costs of medical treatment. However, necessary facilities, emergency treatment, and professional services will be available to you, just as they are to the general community.  
Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals HIPAA Compliant  
Signing this consent form indicates that you have read this consent form (or have had it read to you),
that your questions have been answered to your satisfaction, and that you voluntarily agree to participate in this research study. You will receive a copy of this signed consent form.  
| Subject                                    | Date   |
|--------------------------------------------|--------|
| Investigator or Designee Obtaining Consent | Date   |
| Witness (if applicable)                    | Date   |
| Translator (if applicable)                 | Date   |
Clinical trial: NCT01986140
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Potential Risks And Discomforts|Research Related Injury

There are side effects or risks that could occur during this study. Because this is a "randomized" study, there is always the risk that you will not be in the group that receives the scalp cooling treatment. In that case, the list of side effects would not apply to you.

The study team and the clinical staff will watch over you closely during your treatments and will assist you by removing the cap or helping to make you more comfortable while you are using the cap.  
Research personnel will try to reduce, control, and treat any complications from this research. If you are injured because of this study, you will receive medical care that you or your insurance will have to pay for just like any other medical care.
Clinical trial: NCT01986140
Section: Procedures
Subsections: Procedures

The research will be conducted at the following location(s):
Baylor College of Medicine, HCHD: Harris County Hospital District, and Harris Health System- Smith Clinic.  
We are hoping to enroll 235 patients onto this study. We plan to offer this study at up to 10 sites. Baylor College of Medicine is one of the 10 sites. There are two clinics at Baylor College of Medicine that will enroll subjects for this study. One of the clinics is at the Baylor Clinic and the other is at the Smith Clinic which is part of the Harris Health Services. If you are interested in being in this study, you will need to discuss this document (consent) with your doctor and the study team. You may want to take this consent home and talk about it with your family or friends before deciding to join the study. If you decide that you want to participate in the study you will have a study visit with the research doctor and team. This visit will be called your "baseline" visit. At this time the study team will collect information about you like your age, height, race, etc. You will have a brief exam by the doctor and you will have an ECOG performance status test. The ECOG performance status test is a test that many doctors use to see how well their patients are handling day-to-day activities while they are being treated for cancer.  
You will be asked about any current medications that you are taking, including over the counter treatments and vitamins. You will have your blood drawn, (about one to two teaspoons) to make sure that you can join this study. If your blood was already drawn within the past 4 weeks, the study doctor will make sure that the tests needed to join this study have been done. If they have been done, you may not need to have another blood draw. If your blood was tested for TSH (a test that can determine if you are likely to lose your hair)
in the past year, this test will not need to be repeated. The study team will ask you about your medical history. You will be given a "baseline alopecia score."
This first score is important because it will be used throughout the study to see how much hair-loss you have experienced during chemotherapy. Once you are enrolled onto the trial, you will be randomized into one of two groups. Randomized means that neither you nor your doctor can choose the group. This procedure is done by chance just like when you flip a coin. Some patients will be randomized into the group that will have the scalp cooling device during chemotherapy treatment. This group is called the "study group". The other group will not have scalp cooling. This group is called a "control". The "control" group is the group that receives "standard of care" or what is known as routine or "regular" care. Having two groups will help us see if using the Orbis Scalp Cooler device is helpful or not in preventing hair loss.  
If you are randomized into the scalp cooling group, you will be given a brochure with instructions on proper hair care. You will also need to have a cooling cap fitting. This procedure is very important because the cap must fit snugly onto your head to be effective. You will be asked to wear the scalp cooling cap at every visit for chemotherapy. If you are in the control group, you will not need to wear the scalp cooling cap. Both groups will be asked to complete some questionnaires. Before you have chemotherapy we will give you 3 questionnaires to complete. They will only take about 10 minutes to complete. These questionnaires will be completed again after 4 cycles of chemotherapy and again after you have completed all of your chemotherapy treatments (if you were scheduled for more than 4 cycles). The questionnaires will help us understand your feelings about yourself and in particular if your hair loss changes your feelings in any way. The participants randomized to the scalp cooling group will wear the Orbis Scalp Cooler (cap) for at least 30 minutes prior to chemotherapy, during the chemotherapy infusion and for at least 90 minutes after the end of your infusion. The study nurse will record the start and stop times when you are wearing the cap. You will have the cap loosened for 5 minutes before it is removed and you will have another 5 minutes to allow your scalp to warm up. Right after the cap is removed, we will ask you to rate your comfort level. This information can help us understand if the cap is uncomfortable or bothersome during or after the treatments. If you are wearing the cooling cap and you still lose most of your hair, we will stop treating you with the cooling cap, but would still like you to complete the questionnaires at the required time point(s). If you should stop the treatment with the cap because it bothers you too much, we also would like you to complete the questionnaires at the required time point(s). You will be seen by a medical oncologist and one other health care provider 2 to 3 weeks after each cycle of chemotherapy treatment to see if there are any changes in hair loss. The second health care provider will be "blinded" to the group you are in. This means, they are not supposed to know whether you received scalp cooling or whether you received routine care. If you enroll on this study, we ask that you agree not to tell the blinded observer what arm (treatment group) you are in. The loss of hair, if any, will be documented by using a picture scale. You will be asked to judge your own hair loss and we will ask you if you used a head cover (hat) or wore a wig between treatments. If you are one of the first 25 patients enrolled, we will ask your permission to take photographs at your baseline visit and 2 to 3 weeks after each chemotherapy treatment of your right side, left side, front and back of the head as well as the top of the head. Your personal information will not be written on these photographs and your name will not be associated with them if they are ever published. If you are not one of the first 25 patients enrolled, photos will only be taken at your baseline visit, 2 to 4 weeks after 4 cycles of chemotherapy and 2-4 weeks after your last chemotherapy treatment (if you're getting more than 4 cycles). The photos may be published or presented as educational tools for training during and after the study is completed. You will not be identified in any of the pictures because they will not include your face and will be taken in such a way as to prevent you from being recognized. Everyone in the study will be seen by the study team within 2 to 4 weeks after finishing chemotherapy. At the last visit, a final review of hair loss will be done and you will complete your last set of questionnaires.  
We would like to continue to contact you once a year for the next five years after you finish the treatment .  
This would be done during your routine clinic visits to the doctor or by calling you on the phone once a year to see how you are doing and to learn if your cancer has returned.
Clinical trial: NCT01986140
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this study is entirely voluntary. Should you decide not to participate in the study, you will continue to receive the best possible treatment from your doctor. Being in the study or not being in the study will have no effect on the treatment of your breast cancer. You may withdraw from the study at any time. Your decision will not affect your future medical care and treatment. If you do agree to take part in the study, you are free to withdraw from the study at any time, without having to give a reason, and this will in no way affect your future healthcare. Your doctor may also stop your participation in the study should he or she determines that this study is not in your best medical interest. Please read this document carefully before you make a decision about participating in this clinical trial, and ask your doctor or a member of the study team to explain anything that is unclear to you. Your doctor and the Sponsor of the study (Paxman) want to make sure you fully understand the study and its requirements. If you decide to participate in this study, you will be asked to sign this consent form. By signing, you are indicating that you have read and understand the information. It also shows us that you will join in this study, and will follow the study requirements, including the follow-up visits.
Clinical trial: NCT01986140
Section: Withdrawal from Study
Subsections: Investigator Withdrawal Of Subject From A Study

The investigator or sponsor may decide to stop you from taking part in this study at any time. You could be removed from the study for reasons related only to you (for example, if you move to another city, if you do not want to use the scalp cooling cap, or if you have a serious reaction to the device) or because the entire study is stopped. The sponsor, investigator, Food and Drug Administration, or Institutional Review Board may stop the study at any time.