Clinical trial: NCT03934905
Section: Confidentiality
Subsections: 10. What About Confidentiality And The Privacy Of My Records?|Texas Tech University Health Sciences Center Authorization To Use And/Or Disclose Your Protected Health Information For A Research Study

We will keep your involvement in this research study confidential to the extent permitted by law. In addition to the staff carrying out this study, others may learn that you are in the study. This might include federal regulatory agencies such as the Food and Drug Administration (FDA) and the Office for Human Research Protection (OHRP), Texas Tech University Health Sciences Center (TTUHSC) representatives, representatives from any hospital or site where the research takes place, and the TTUHSC Institutional Review Board (a committee that reviews and approves research). These people may review and copy records involving your participation in this research. A copy of this document may be placed in your medical record. Study results that are used in publications or presentations will not use your name.  
11. **Who is funding this study?**
This study will be funding by the NIH and DoD and interamural funding and the Department of Internal Medicine are providing the space and supplies for this study. No  
 one on the research staff will receive anything of value from other agencies, organizations, or companies to carry out this research.

STUDY TITLE: Phase II trial of effect of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction This form is intended to tell you about the use and/or disclosure (sharing) of your personal Protected Health Information (PHI) if you decide to participate in the research study described on the previous pages. The health information about you that may be used or disclosed is described below. This information is usually found in your medical records. Only the health information about you that is needed for this research study will be used or disclosed. When you consider taking part in this research study, you are also being asked to give your permission for your Protected Health Information to be released from your doctors, clinics, and hospitals to the research personnel approved for this research study. This Authorization specifically relates to the research study described in the attached Informed Consent document. 1. This Authorization is valid indefinitely or until such time as legal requirements will allow this Authorization to be destroyed.  
2. If you choose to cancel this Authorization, please give notice in writing to:
Clinical trial: NCT03934905
Section: Duration of Study Involvement
Subsections: Baseline Visit:|One Week After Your Fourth Dox Infusion:|A Year After Your Dox Treatment Is Done:

There will be two groups in this study: one group will receive the SFN and the other will receive placebo.  
You will be randomized (like flipping a coin) into either the study group or the placebo group. You and your doctor will not know which group you are in until the end of the study.  
You will be given your pills and instructions on how to take them.  
o **You will be asked NOT to take any other OTC supplements while you**
are in this study.  
You will complete a questionnaire about your general health. You will have about 2 tablespoons of blood drawn according to your standard of care and some of the blood will be used for research purposes to tell us more about your heart health related to the DOX treatment.  
You will be weighed per your standard of care.

You will have about 2 tablespoons of blood drawn according to your standard of care and some of the blood will be used for research purposes to tell us more about your heart health related to the DOX treatment.  
You will have an ECHO and PET CT done for research purposes and complete a questionnaire about your general health.  
You will be weighed per your standard of care.  
You will need to bring your pills so we can count them and we will give you more.  
You will take the pills for one year.

You will have about 2 tablespoons of blood drawn according to your standard of care and some of the blood will be used for research purposes to tell us more about your heart health related to the DOX treatment.  
  
You will have an ECHO done for research purposes.  
You will have your pills counted.  
While you are in this study we will also take information from your medical record such as ethnicity, age, height and information about your cancer.  
5. How much of my time will this study take? **How long will I be in the study?**
You will be in this study for a year.  
6. Are there any benefits to me **if I take part in this study?**
None No. However the subjects that receive the SFN may benefit from the supplement, but this is not guaranteed.
Clinical trial: NCT03934905
Section: Participant's Rights
Subsections: 16. What Are My Rights As A Voluntary Participant?

Taking part in this study is your choice. If you sign this form, it means that you choose to be in the study. You may also choose not to be in this study. If you decide not to be in the study, it will not affect any medical care, benefits or rights to which you are entitled.  
If new information becomes available during the study that may affect your willingness to take part in the study, you will be told.  
17. **Can I stop being in the study?**
You may leave the study at any time. If you leave the study, we cannot remove any information we have collected to that point.
Clinical trial: NCT03934905
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 7. What Are The Risks And/Or Discomforts To Me If I Join This Study?|15. What If I Am Hurt By Participating In This Study?

Sulforaphane Risks:
Side effects may include vomiting, abdominal pain, constipation, increased appetite Blood Draw Risks:
Pain, discomfort, redness, infection, bleeding, bruising and swelling at the draw site.  
There may be other risks that are unknown.  
8. **Will there be any added risks to me from this study if I am a female?**
Only females will be enrolled in this study therefore the risks above apply to you.  
9. **What other choices do I have if I do not take part in the research study?**
This study does not involve treatment. You do not have to take part in this study.

Texas Tech University Health Sciences Center does not offer to pay for or cover the cost of medical treatment for research related illness or injury. No funds have been set aside to pay or reimburse you in the event of such injury or illness unless specifically stated. If you have a research related illness or injury, care will be available to you as usual, but you and/or your medical or hospital insurance company will be responsible for the cost of treatment. Before entering this study, you should check whether your insurance company might limit your insurance coverage if you take part in a research study.
Clinical trial: NCT03934905
Section: Procedures
Subsections: First Through Fourth Dox Infusion:

You will receive your DOX infusion according to your standard of care.  
You will have about 2 tablespoons of blood drawn according to your standard of care and some of the blood will be used for research purposes to tell us more about your heart health related to the DOX treatment.  
You will need to bring your pills so we can count them. We will also give you more pills.  
You will be weighed per your standard of care.
Clinical trial: NCT03934905
Section: Purpose of Research
Subsections: Each Page. Consent To Take Part In A Research Study

This is a research study for people who voluntarily choose to take part. Please take your time to make a decision, and discuss the study with your personal doctor, family and friends if you wish. STUDY TITLE: Phase II trial of effect of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction INVESTIGATORS: Sharda Singh, PhD; Sanjay Awsathi, MD; Nadini Nair, MD, PhD; Sriman Swarup, MBBS, MD
Clinical trial: NCT03934905
Section: Withdrawal from Study
Subsections: 18. Can Someone Else End My Participation In The Study?

Under certain circumstances, the investigators, TTUHSC, or the study sponsor may decide to end your participation in this research study earlier than planned. This might happen because your doctor thinks it's in your best interest to stop being in the study or the study ends for any other reason.  
19. **What if I have questions?**
For questions about this study, contact the Investigator, Dr. Sharda Singh at 806-7431540. If you would like to speak to someone who is not involved in the study about your rights  
 as a participant, research-related injuries, or any other matter related to the study, you can call the TTUHSC EthicsPoint Hotline: 1-866-294-9352. Or, you can file an EthicsPoint report online:
https://secure.ethicspoint.com/domain/media/en/gui/12958/index.html. Please choose the
"Regulatory Compliance" option when making an online report.  
A description of this clinical trial will be available on https://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.  
Your signature indicates that:
**this research study has been explained to you;**
**you have been given the opportunity to ask questions and have received answers;** you accept your responsibility to follow the instructions given to you by the research team regarding study participation and, if applicable, research medication; you agree to take part in this study.  
You will be given a signed copy of this form. Printed Name of Subject  
| Signature of Subject         | Date   | Time   |
|------------------------------|--------|--------|
| Signature of Parent/Guardian | Date   | Time   |
| or Authorized Representative |        |        |  
_____ Subject was unable to read and understand the written consent. The elements of informed consent required by 45 CFR 46.116 and 21 CFR 50 have been presented orally to the subject or the subject's authorized representative in a language understandable to the subject or representative. _  
 Signature of Witness to Oral Presentation Date Time I have discussed this research study with the subject and his or her authorized representative, using language that is understandable and appropriate. I believe I have fully informed the subject of the possible risks and benefits, and I believe the subject understands this explanation. I have given a copy of this form to the subject. Signature of authorized research personnel who Date Time conducted the informed consent discussion