Breast Cancer Protocols:

For XyChloro® Photodynamic Therapy (XPDT) and XyChloro® Sonodynamic Therapy (XSDT) Treatment of BREAST CANCER PATIENTS

PRE-PROTOCOL PATIENT EVALUATION

Upon initial contact from a potential patient, the XYTOS staff will go through a brief interview either by phone or e-mail with the patient to determine the specific type of cancer to be treated. During this interview, the XYTOS staff will first determine if the patient, to be treated, falls within our exclusion criteria. If the patient does not fall into the exclusion criteria, the XYTOS staff will compile the information taken in the brief interview and turn the information over to our supervising doctors for a preliminary review.

If the cancer to be treated falls within an area that is outside of XYTOS’ current ability to treat or if the cancer to be treated falls into an area where XYTOS has had only limited success, the XYTOS staff will respond to the patient advising them that, at the present time, XYTOS feels that the XPDT/XSDT treatment would not be beneficial to the patient, but that their information will remain on file and at the time that XYTOS feels that XPDT/XSDT would be beneficial to the patient, we will contact them. The patient is also advised to continue to review the XYTOS website as we announce other areas of cancer that we will be treating.

If the cancer to be treated falls within an area that XYTOS has the ability to treat, the XYTOS staff will respond to the patient with a request that they complete the Patient’s Questionnaire and the Doctor’s Questionnaire, which includes a cover letter requesting all recent medical records and scans. This information is then passed on to our supervising doctors for a more extensive review of the patient’s condition. After review of the documentation received from the patient and the patient’s physician, the supervising doctors will determine if the patient’s treatment needs fall within XYTOS’ capabilities. If the patient’s need for treatment falls outside of XYTOS’ treatment ability, the XYTOS staff will respond as detailed in the paragraph above. If the supervising doctors determine that the XYTOS treatment procedure would be beneficial to the patient, the XYTOS staff will schedule a patient for treatment.

Prior to the patient arriving at the treatment center, the supervising doctors and treating doctors will review the patient’s documentation received, and the treating doctors will move forward with the below detailed protocol.

Protocol One

If the patient has a lump/cancerous tumor in the breast with metastases in the lymph node area, XYTOS may recommend that the patient have a lumpectomy (depending on the size of the lump in the breast) and possibly the removal of the sentinal node prior to starting XPDT and XSDT as referenced in Protocol (1). The XYTOS doctors in conjunction with the patient's personal physician will make a decision as to the patient's need for surgery prior to the XYTOS treatment. Note that XPDT/XSDT works best on smaller tumors and metastases and XYTOS will look to work with the patient's personal physician/surgeon if the XYTOS doctors determine that a large cancerous tumor would be slow to react to XPDT or XSDT.

Protocol Two

If no operative procedures have been carried out or after XYTOS has determined that there has been sufficient time since any operative procedures, the XYTOS treating doctors will proceed in accordance with the protocol for Day 1.

Day 1
· Microscope - for evaluation of quality of the patient's blood cells. Specifically looking for blood cells showing a cancerous disturbance.
· Sonogram for evaluation of quality and quantity of cancer cells in the body
· Sub-lingual absorption of 10ml XyChloro® (approximately one hour per day)
· Daily notes and CD/DVD RECORDS

Day 2
· Sub-lingual absorption of 10ml XyChloro®
· Daily notes and CD/DVD RECORDS

Day 3
· Sub-lingual absorption of 10ml XyChloro®
· Daily notes and CD/DVD RECORDS

Day 4
· Rest while XyChloro absorbs into the patients cancer cells

Day 5
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and the introduction of Fluorescent Scanning
· Daily notes and CD/DVD RECORDS.
· TREATMENT IS APPROXIMATELY TWO HOURS EACH DAY

Day 6
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 7
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and
· Fluorescent Scanning
Daily notes and CD/DVD RECORDS

Day 8
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 9
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and the introduction of Fluorescent Scanning
· Daily notes and CD/DVD RECORDS

Day 10
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 11

· Rest or Continued Treatment to be determined by the XYTOS Medical Staff

Day 12

· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and the introduction of Fluorescent Scanning
· Daily notes and CD/DVD RECORDS.

Day 13
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 14
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and
· Fluorescent Scanning
· Daily notes and CD/DVD RECORDS

Day 15
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 16
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and the introduction of Fluorescent Scanning
· Daily notes and CD/DVD RECORDS

Day 17
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 18
The patient is observed through Fluoroscopy, Microscopy and Sonogram to determine the success of the treatment and to further determine if additional treatment would be necessary.

Results are discussed with the patient. If completely clear, there after the normal follow-up is three months, six months, and then annually, depending on the patient's condition. Many patients may return for preventative procedures.

If there are still evidence of cancer, the patient should be given a further 3-5 days of treatment and re-evaluated by fluoroscopy, microscopy and sonography. If still not clear, XYTOS medical staff and patient to discuss further options.

Upon completion of the treatment process a letter is written to the patient primary care physician describing in detail the patient treatment and progress. The patient also leave with CD /DVD details of their conditions before during and after the treatment. This information can be shared with the patients Primary Care Physician if the patient chooses to do so.

Prostate Cancer Protocol:

PROTOCOL
For XyChloro® Photodynamic Therapy (XPDT) and XyChloro® Sonodynamic Therapy (XSDT) Treatment of PROSTATE CANCER PATIENTS

PRE-PROTOCOL PATIENT EVALUATION

Upon initial contact from a potential patient, the XYTOS staff will go through a brief interview either by phone or e-mail with the patient to determine the specific type of cancer to be treated. During this interview, the XYTOS staff will first determine if the patient, to be treated, falls within our exclusion criteria. If the patient does not fall into the exclusion criteria, the XYTOS staff will compile the information taken in the brief interview and turn the information over to our supervising doctors for a preliminary review.

If the cancer to be treated falls within an area that is outside of XYTOS’ current ability to treat or if the cancer to be treated falls into an area where XYTOS has had only limited success, the XYTOS staff will respond to the patient advising them that, at the present time, XYTOS feels that the XPDT/XSDT treatment would not be beneficial to the patient, but that their information will remain on file and at the time that XYTOS feels that XPDT/XSDT would be beneficial to the patient, we will contact them. The patient is also advised to continue to review the XYTOS website as we announce other areas of cancer that we will be treating.

If the cancer to be treated falls within an area that XYTOS has the ability to treat, the XYTOS staff will respond to the patient with a request that they complete the Patient’s Questionnaire and the Doctor’s Questionnaire, which includes a cover letter requesting all recent medical records and scans. This information is then passed on to our supervising doctors for a more extensive review of the patient’s condition. After review of the documentation received from the patient and the patient’s physician, the supervising doctors will determine if the patient’s treatment needs fall within XYTOS’ capabilities. If the patient’s need for treatment falls outside of XYTOS’ treatment ability, the XYTOS staff will respond as detailed in the paragraph above. If the supervising doctors determine that the XYTOS treatment procedure would be beneficial to the patient, the XYTOS staff will schedule a patient for treatment.

Prior to the patient arriving at the treatment center, the supervising doctors and treating doctors will review the patient’s documentation received, and the treating doctors will move forward with the below detailed protocol.

Day 1
· Microscope - for evaluation of quality of the patient's blood cells. Specifically looking for blood cells showing a cancerous disturbance.
· Sonogram for evaluation of quality and quantity of cancer cells in the body
· Sub-lingual absorption of 10ml XyChloro® (approximately one hour per day)
· Daily notes and CD/DVD Records

Day 2
· Sub-lingual absorption of 10ml XyChloro®
· Daily notes and CD/DVD RECORDS

Day 3
· Sub-lingual absorption of 10ml XyChloro®
· Daily notes and CD/DVD RECORDS

Day 4
· Rest while XyChloro absorbs into the patients cancer cells

Day 5
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Rectal probe for 3-5 minutes
· Repeat microscopy and sonography after sound, light, and rectal treatment for evaluation of quality and quantity and nature of cancer cells in the body
· Daily notes plus CD/DVD records; additional record of any symptoms patient may experience such as nocturia, frequency, dysensia
· TREATMENT IS APPROXIMATELY TWO HOURS EACH DAY

Day 6
· Repeat light, sound, oxygen and rectal probe
· Evaluate possibility of extending limit given to patient i.e. up to maximum 30 minutes for light and sound, and maximum 5 minutes for oxygen and rectal
· Daily notes and CD/DVD RECORDS

Day 7
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Rectal probe for 3-5 minutes
· Repeat microscopy and sonography after sound, light, and rectal treatment for evaluation of quality and quantity and nature of cancer cells in the body
· Daily notes plus CD/DVD records; additional record of any symptoms patient may experience such as nocturia, frequency, dysensia

Day 8
Maximum level of light, sound, oxygen, and rectal therapy
Daily notes and CD/DVD RECORDS

Day 9
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Rectal probe for 3-5 minutes
· Repeat microscopy and sonography after sound, light, and rectal treatment for evaluation of quality and quantity and nature of cancer cells in the body
· Daily notes plus CD/DVD records; additional record of any symptoms patient may experience such as nocturia, frequency, dysensia

Day 10
Maximum level of light, sound, oxygen, and rectal therapy
Daily notes and CD/DVD RECORDS

Day 11

Rest or Continued Treatment to be determined by the XYTOS Medical Staff

Day 12
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Rectal probe for 3-5 minutes
· Repeat microscopy and sonography after sound, light, and rectal treatment for evaluation of quality and quantity and nature of cancer cells in the body
· Daily notes plus CD/DVD records; additional record of any symptoms patient may experience such as nocturia, frequency, dysensia

Day 13
Repeat light, sound, oxygen and rectal probe
Evaluate possibility of extending limit given to patient i.e. up to maximum 30 minutes for light and sound, and maximum 5 minutes for oxygen and rectal
Daily notes and CD/DVD RECORDS

Day 14
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Rectal probe for 3-5 minutes
· Repeat microscopy and sonography after sound, light, and rectal treatment for evaluation of quality and quantity and nature of cancer cells in the body
· Daily notes plus CD/DVD records; additional record of any symptoms patient may experience such as nocturia, frequency, dysensia

Day 15
Maximum level of light, sound, oxygen, and rectal therapy
Daily notes and CD/DVD RECORDS

Day 16
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Rectal probe for 3-5 minutes
· Repeat microscopy and sonography after sound, light, and rectal treatment for evaluation of quality and quantity and nature of cancer cells in the body
· Daily notes plus CD/DVD records; additional record of any symptoms patient may experience such as nocturia, frequency, dysensia

Day 17
Maximum level of light, sound, oxygen, and rectal therapy
Daily notes and CD/DVD RECORDS

Day 18
The patient is observed through Fluoroscopy, Microscopy and Sonogram to determine the success of the treatment and to further determine if additional treatment would be necessary.

Results are discussed with the patient. If completely clear, there after the normal follow-up is three months, six months, and then annually, depending on the patient's condition. Many patients may return for preventative procedures.

If there are still evidence of cancer, the patient should be given a further 3-5 days of treatment and re-evaluated by fluoroscopy, microscopy and sonography. If still not clear, XYTOS medical staff and patient to discuss further options.

Upon completion of the treatment process a letter is written to the patient primary care physician describing in detail the patient treatment and progress. The patient also leave with CD /DVD Record with details of their conditions before during and after the treatment. This information can be shared with the patients Primary Care Physician if the patient chooses to do so.

Skin Cancer Protocol:

PROTOCOL
For XyChloro® Photodynamic Therapy (XPDT) and XyChloro® Sonodynamic Therapy (XSDT) Treatment of SKIN CANCER PATIENTS

PRE-PROTOCOL PATIENT EVALUATION

Upon initial contact from a potential patient, the XYTOS staff will go through a brief interview either by phone or e-mail with the patient to determine the specific type of cancer to be treated. During this interview, the XYTOS staff will first determine if the patient, to be treated, falls within our exclusion criteria. If the patient does not fall into the exclusion criteria, the XYTOS staff will compile the information taken in the brief interview and turn the information over to our supervising doctors for a preliminary review.

If the cancer to be treated falls within an area that is outside of XYTOS’ current ability to treat or if the cancer to be treated falls into an area where XYTOS has had only limited success, the XYTOS staff will respond to the patient advising them that, at the present time, XYTOS feels that the XPDT/XSDT treatment would not be beneficial to the patient, but that their information will remain on file and at the time that XYTOS feels that XPDT/XSDT would be beneficial to the patient, we will contact them. The patient is also advised to continue to review the XYTOS website as we announce other areas of cancer that we will be treating.

If the cancer to be treated falls within an area that XYTOS has the ability to treat, the XYTOS staff will respond to the patient with a request that they complete the Patient’s Questionnaire and the Doctor’s Questionnaire, which includes a cover letter requesting all recent medical records and scans. This information is then passed on to our supervising doctors for a more extensive review of the patient’s condition. After review of the documentation received from the patient and the patient’s physician, the supervising doctors will determine if the patient’s treatment needs fall within XYTOS’ capabilities. If the patient’s need for treatment falls outside of XYTOS’ treatment ability, the XYTOS staff will respond as detailed in the paragraph above. If the supervising doctors determine that the XYTOS treatment procedure would be beneficial to the patient, the XYTOS staff will schedule a patient for treatment.

Prior to the patient arriving at the treatment center, the supervising doctors and treating doctors will review the patient’s documentation received, and the treating doctors will move forward with the below detailed protocol.

Day 1
· Microscope - for evaluation of quality of the patient's blood cells. Specifically looking for blood cells showing a cancerous disturbance.
· Sonogram for evaluation of quality and quantity of cancer cells in the body
· Sub-lingual absorption of 10ml XyChloro® (approximately one hour per day)
· Daily notes and CD/DVD RECORDS

Day 2
· Sub-lingual absorption of 10ml XyChloro®
· Daily notes and CD-ROM

Day 3
· Sub-lingual absorption of 10ml XyChloro®
· Daily notes and CD-ROM

Day 4
· Rest while XyChloro absorbs into the patients cancer cells

Day 5
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and the introduction of Fluorescent Scanning
· Daily notes and CD/DVD RECORDS.
· TREATMENT IS APPROXIMATELY TWO HOURS EACH DAY

Day 6
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 7
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and
· Fluorescent Scanning
· Daily notes and CD/DVD RECORDS

Day 8
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 9
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and the introduction of Fluorescent Scanning
· Daily notes and CD/DVD RECORDS

Day 10
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 11
· Rest or Continued Treatment to be determined by the XYTOS Medical Staff

Day 12
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and the introduction of Fluorescent Scanning
· Daily notes and CD/DVD RECORDS.

Day 13
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 14
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and
· Fluorescent Scanning
· Daily notes and CD/DVD RECORDS

Day 15
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 16
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Repeat microscopy and sonography after sound, light, and oxygen and the introduction of Fluorescent Scanning
· Daily notes and CD/DVD RECORDS

Day 17
· Light therapy - general and specific for approximately 20-30 minutes
· Oxygen and general aerobic activity for 3-5 minutes to increase oxygen in blood
· Sound therapy to affected area for 20-30 minutes
· Daily notes and CD/DVD RECORDS

Day 18
The patient is observed through Fluoroscopy, Microscopy and Sonogram to determine the success of the treatment and to further determine if additional treatment would be necessary.

Results are discussed with the patient. If completely clear, there after the normal follow-up is three months, six months, and then annually, depending on the patient's condition. Many patients may return for preventative procedures.

If there are still evidence of cancer, the patient should be given a further 3-5 days of treatment and re-evaluated by fluoroscopy, microscopy and sonography. If still not clear, XYTOS medical staff and patient to discuss further options.

Upon completion of the treatment process a letter is written to the patient primary care physician describing in detail the patient treatment and progress. The patient also leave with CD /DVD details of their conditions before during and after the treatment. This information can be shared with the patients Primary Care Physician if the patient chooses to do so.