Consent for Supportive Oligonucleotide Technique

Please read this form entirely.  It contains information to assist you in making a decision to have a specific therapy.  Initial each paragraph if you understand it.  If you do not understand it, do not initial it and each paragraph will be discussed with you separately.  There are risks and complications that may result from this therapy, they are rare, but do exist and you must be aware of them.

Supportive Oligonucleotide Technique (SOT) is a treatment for cancer or infections with viruses or Lyme bacteria.  Essentially SOT is the creation of a shutoff “key” that precisely fits a chosen “lock” portion of a cancer cell or pathogen.  The “lock” is a specific section of DNA that normally controls an important function of the cancer cell or pathogen.  The “key” binds to the “lock” and blocks the function thus killing the cancer cell or pathogen.  After the cancer cell or pathogen dies the SOT compound is released and travels to the next target, thus fighting the cancer or infection 24/7 for months.

SOT is given by intravenous infusion.   Medications given prior to the SOT infusion include ranitidine and dexamethasone, both to minimize the chances of allergic reactions and to increase the efficacy of the SOT treatment.

_____ Possible side effects include headache, flu-like symptoms, fever, body aches, sweating, diarrhea, cough, asthma flare.

_____ Rare complications with cancer treatment include “tumor lysis syndrome” which might lead to high blood potassium, high blood phosphate, low blood calcium, high blood uric acid and higher than normal levels of blood urea nitrogen and other nitrogen-containing compounds.  The metabolic abnormalities seen in tumor lysis syndrome can ultimately result in nausea and vomiting, but more seriously edema, fluid overload, kidney damage, seizures, congestive heart failure, abnormal heart rhythm, syncope, sudden death.

_____ Other rare complications with cancer treatment may include those secondary to fluid accumulation around areas of dying cancer cells.  This may lead to seizures.  This may lead to fluid in the lung or abdomen that needs to be drained.

_____ The above listed risks may occur, but there may be unforeseen risks and risks that are not included on this list.  Some of these risks, if they occur, may necessitate hospitalization and/or extended outpatient therapy to permit adequate treatment.

_____ I will conform and comply with the recommended dosing of SOT.  If recommended, I will obtain baseline and periodic lab tests to assure proper monitoring of my SOT.

_____ I understand that medicine is not an exact science and that no guarantees are offered regarding my expected results.  I am aware that it is possible that this treatment will not work for me.

I have read the foregoing information, it has been explained, and I understand it.  All of my questions have been answered.  By executing this form, I am indicating that I have no questions whatsoever and I give my full informed consent to have SOT prescribed.

Patient / Legal Guardian Signature / Date:

Nurse/Physician / Date:

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