Clinical trial: NCT02369835
Section: Confidentiality
Subsections: Confidentiality|What Personal Information Will Be Obtained, Used Or Disclosed?|Who May Use Or Disclose The Information?|Who May Receive Or Use The Information?

Your identity will be kept as confidential as possible as required by law. However, there is always some risk that even de-identified information might be re-identified. Your personal health information related to this study may be disclosed as authorized by you. Your research records may be disclosed outside of Stanford, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to research study personnel. The results of this research study may be presented at scientific or medical meetings or published in scientific journals. However, your identity will not be disclosed. Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction. The purpose of this research study is to obtain data or information on the safety and effectiveness of diluted bleach. The results may be provided to the Food and Drug Administration and other federal and regulatory agencies as required.  
Protocol Title: A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it.

Your name, date of birth, and medical record number will be used to properly identify you. Other health information that may be used with this research study, include, but are not limited to, medical records, pathology reports, imaging studies, physical examinations, and research photographs.

The following parties are authorized to use and/or disclose your health information in connection with this research study:
The Protocol Director, Dr. Beth Beadle The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary Research staff, co-investigators, and research lab personnel

The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:
The Office for Human Research Protections in the U.S. Department of Health and Human Services Data Safety Monitoring Committee (DSMC)
Regulatory authorities in the United States, e.g., the Food and Drug Administration Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.
Clinical trial: NCT02369835
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

This research study is expected to take approximately three to seven weeks of active treatment depending on your individualized radiation course which is determined by your radiation oncologist. There will be one follow-up visit between three and twelve weeks after the conclusion of your radiation course.
Clinical trial: NCT02369835
Section: Participant Responsibilities
Subsections: Participant Responsibilities

As a participant, your responsibilities include:
Follow the instructions of the Protocol Director and study staff. Apply the diluted bleach solution and control solution as instructed Keep your study appointments. If it is necessary to miss an appointment, please contact the Protocol Director or research study staff to reschedule as soon as you know you will miss the appointment.  
Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.  
Tell the Protocol Director or research staff if you believe you might be pregnant or gotten your partner pregnant.  
Keep the diluted bleach solution in a safe place, away from children and for your use only.  
Complete your questionnaires as instructed. Ask questions as you think of them. Tell the Protocol Director or research staff if you change your mind about staying in the study.  
| Protocol Director:   | Beth Beadle, M.D.   | eProtocol 32439   |
|----------------------|---------------------|-------------------|  
Protocol Title: A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer
Clinical trial: NCT02369835
Section: Participant's Rights
Subsections: Participant'S Rights|Experimental Subject'S Bill Of Rights

You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director.  
  
Protocol Title: A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.

As a research participant you have the following rights. These rights include but are not limited to the participant's right to:
be informed of the nature and purpose of the experiment;  
be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized;  
be given a description of any attendant discomforts and risks reasonably to be expected; be given an explanation of any benefits to the subject reasonably to be expected, if applicable;
be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits;  
be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise; be given an opportunity to ask questions concerning the experiment or the procedures involved; be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and
be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.  
| IRB Use Only                                                     |
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| Approval Date: April 9, 2018  Expiration Date: December 15, 2018 |  
  
  
Protocol Title: A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer May we contact you about future studies that may be of interest to you?  Yes  No Signing your name means you agree to be in this study and that you were given a copy of this signed and dated consent form. _____________________________________ ____________ Signature of Adult Participant Date _____________________________________ Print Name of Adult Participant _____________________________________ ____________ Signature of Legally Authorized Representative (LAR) Date
(e.g., parent, guardian or conservator) _____________________________________ ________________________________ Print Name of LAR LAR's Authority to Act for Participant (e.g., parent, guardian or conservator) _____________________________________ ____________ Signature of Person Obtaining Consent Date _____________________________________ Print Name of Person Obtaining Consent The following witness line is to be signed only if the consent is provided as a summary form and accompanied by a short form foreign language consent.  
_____________________________________ ____________ Signature of Witness Date Print Name of Witness: ____________________________________________
(e.g., staff, translator/interpreter, family member)
Translated short form must be signed and dated by both the participant (or their LAR) AND the witness.  
The English consent form (referred to as the "Summary Form" in the regulations):
o Must be signed by the witness AND the Person Obtaining Consent (POC).  
o The non-English speaking participant/LAR does not sign the English consent. o The non-English speaking participant/LAR should not sign the HIPAA participant line o If the participant or the LAR is non-English speaking, the Person Obtaining Consent (POC) must ensure that 1) the LAR's Description of Authority is completed and 2) that any questions or options presented by the consent form are documented and initialed by the POC on the Summary Form, per the participant's wishes, as they are understood during the consent process.
Clinical trial: NCT02369835
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks, **Discomforts, And Inconveniences**

There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions. You may have to come to Stanford Medical Center for a separate appointment for this study, which may be an inconvenience of travel. Potential risks associated with dilute bleach are skin itching and skin irritation. Prior human clinical trials demonstrated no significant risk of dilute 0.005% bleach. One patient had itching and mild skin irritation.  
  
  
Protocol Title: A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer The short-term toxicities from radiotherapy include fatigue and skin changes. Long-term toxicities include fibrosis or scarring, damage to the nerves, or lymphedema.
Clinical trial: NCT02369835
Section: Procedures
Subsections: Procedures

If you choose to participate, Dr. Beth Beadle and her research staff will describe all procedures recommended. Some of the procedures may be part of your standard medical care, but others are being done solely for the purpose of this study. The radiation therapy you will receive is standard of care and not experimental. The application of the dilute bleach solution is the only experimental part of the study. If you elect to enroll in the study, you will undergo a clinical skin assessment, complete a  
Protocol Title: A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer survey, and be asked for a photograph of the neck prior to treatment. This will be done to compare how the skin changes from the beginning to the end of treatment. Only the treated area will be photographed. These photographs will be stored on a secure and encrypted research computer. Once you begin radiotherapy, you will be asked to apply either a dilute bleach solution or a control solution to the treatment area for 10 minutes prior to each radiation treatment. You will be randomly assigned (like flipping a coin) to use either the dilute bleach solution or a control solution (water). You and your doctor will not know which solution is the bleach solution and which is the control solution. A clinical skin assessment by the treating physician will be performed once a week during radiation and in follow up. Photographs of the treatment area will also be taken. At your next follow up visit, there will be one last skin assessment, survey, and a photograph of your neck. After these procedures, you will have completed the study.  
Any of your samples which are used in research may result in new products, tests or discoveries. In some instances, these may have potential commercial value and may be developed and owned by the Investigators, Stanford University and/or others. However, donors of samples do not retain any property rights to the materials. Therefore, you would not share in any financial benefits from these products, tests or discoveries.
Clinical trial: NCT02369835
Section: Purpose of Research
Subsections: Purpose Of Research|What Is The Purpose Of This Research Study And How Will My Health Information Be Utilized In The Study?

You are invited to participate in a research study of radiation dermatitis, which is a common skin reaction that patients experience after undergoing radiation therapy. We hope to learn if dilute bleach at a concentration of 0.005% can effectively prevent or reduce the occurrence of radiation dermatitis. Bleach baths at this same concentration have been recommended for people suffering from eczema or dermatitis, and we hope to determine if there is some benefit for patients undergoing radiotherapy. You were selected as a possible participant in this study because you are planning to undergo radiation therapy for head and neck cancer. If you decide to terminate your participation in this study, you should notify Dr. Beth Beadle at (650) 723-6194. This research study is looking for 170 patients with head & neck cancer who plan to undergo radiation therapy here at the Stanford Cancer Center.

The purpose of this research study is to evaluate the effect of diluted bleach on reducing the occurrence and severity of radiation dermatitis.  
Your health information may be included anonymously in future publications and submitted to the FDA.
Clinical trial: NCT02369835
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on you or your medical care. You can decide to participate now, but withdraw your consent later and stop being in the study without any loss of benefits or medical care to which you are entitled.
Clinical trial: NCT02369835
Section: Withdrawal from Study
Subsections: Withdrawal From Study|Authorization To Use Your Health Information For Research Purposes If I Sign, Can I Revoke It Or Withdraw From The Research Later?

If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time. Your decision will not affect your ability to receive medical care for your disease and you will not lose any benefits to which you would otherwise be entitled. If you decide to withdraw your consent to participate in this study, you must notify Dr. Beth Beadle at (650) 723-6194.  
If you withdraw from the study, or the study medication is stopped for any reason, You must return all study-related supplies, including unused study drug. Return to the research center for tests that may be needed for your safety.  
Discuss your future medical care with your personal doctor.
The Protocol Director may also withdraw you from the study and instruct you to stop applying the dilute bleach solution without your consent for one or more of the following reasons:  
o Failure to follow the instructions of the Protocol Director and study staff.  
o The Protocol Director decides that continuing your participation could be harmful to you.  
o Pregnancy o You need treatment not allowed in the study. o The study is cancelled. o Other administrative reasons.  
o Unanticipated circumstances.

If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to:  
Protocol Title: A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer Beth Beadle, MD
Stanford Advanced Medicine Center 875 Blake Wilbur Drive, MC 5847 Stanford, CA 94305