Inclusion & Exclusion Criteria

HORTIS I - Soft Tissue Radionecrosis
HORTIS II - Osteoradionecrosis
HORTIS III - Radiation Cystitis
HORTIS IV - Radiation Proctitis
HORTIS V - Radiation Enteritis
HORTIS VI - Gynecologic Radionecrosis
HORTIS VII - Laryngeal Radionecrosis
HORTIS VIII - Prophylaxis

HORTIS I - Soft Tissue Radionecrosis
INCLUSION CRITERIA Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria:
Endarteritis	Hypocellularity	Hypovascularity
Vascular Congestion	Ulceration	Dehiscence
Ischemia	Necrosis	Skin Graft Failure
Skin Flap Failure	Spontaneous Breakdown	Pain
Delayed Healing	Local Tissue Hypoxia
EXCLUSION CRITERIA Patients, who are pregnant or have any of the following illnesses, conditions or requirement: Pregnancy Reactive airway disease Radiographic evidence of pulmonary blebs or bullae Untreated pneumothorax Previously documented ejection fraction less than 35% History of seizures — except childhood febrile seizures Cardiovascular instability Mechanical ventilator support — with the exception of those patients who are immediately (1-5 days) post- operative Unable to follow simple commands Not orientated to person, place, time Participating as a subject in any other clinical research study — if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent.

HORTIS II - Osteoradionecrosis
INCLUSION CRITERIA Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria:
Endarteritis	Hypocellularity	Hypovascularity
Vascular Congestion	Fracture	Exposed Bone
Bone Graft Failure	Fistula	Pain
Delayed Healing	Ulceration	Tissue Hypoxia
Loss of Mandible Bone Height
EXCLUSION CRITERIA Patients, who are pregnant or have any of the following illnesses, conditions or requirement: Pregnancy Reactive airway disease Radiographic evidence of pulmonary blebs or bullae Untreated pneumothorax Previously documented ejection fraction less than 35% History of seizures — except childhood febrile seizures Cardiovascular instability Mechanical ventilator support Unable to follow simple commands Not orientated to person, place, time Participating as a subject in any other medical or biomedical research project — if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent

HORTIS III - Radiation Cystitis
INCLUSION CRITERIA Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria:
Endarteritis	Hypocellularity	Hypovascularity
Vascular Congestion	Hemorrhage	Necrosis
Edema	Telangiectasis	Urgency
Pain	Fistula	Erythema
Contracted Bladder	Dysplasia	Vascularity Ulceration
Tissue Hypoxia
EXCLUSION CRITERIA Patients, who are pregnant or have any of the following illnesses, conditions or requirement: Pregnancy Reactive airway disease Radiographic evidence of pulmonary blebs or bullae Untreated pneumothorax Previously documented ejection fraction less than 35% History of seizures — except childhood febrile seizures Cardiovascular instability Mechanical ventilator support Unable to follow simple commands Not orientated to person, place, time Participating as a subject in any other medical or biomedical research project — if previously involved as a subject, sufficient time must have elapsed to permit “wash out” of any investigational agent

HORTIS IV - Radiation Proctitis
INCLUSION CRITERIA Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria:
Endarteritis	Hypocellularity	Hypovascularity
Mucosal Thickening	Diarrhea	Vomiting
Cramping	Tenesmus	Obstruction
Constipation	Stricture	Perforation
Pain	Fistula	Hemorrhage
Obstipation	Wall Changes	Tissue Hypoxia
Ulceration
EXCLUSION CRITERIA Patients, who are pregnant or have any of the following illnesses, conditions or requirement: Pregnancy Reactive airway disease Radiographic evidence of pulmonary blebs or bullae Untreated pneumothorax Previously documented ejection fraction less than 35% History of seizures — except childhood febrile seizures Cardiovascular instability Mechanical ventilator support Unable to follow simple commands Not orientated to person, place, time Participating as a subject in any other medical or biomedical research project — if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent

HORTIS V - Radiation Enteritis
INCLUSION CRITERIA Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria:
Endarteritis	Hypocellularity	Hypovascularity
Mucosal Thickening	Diarrhea	Vomiting
Cramping	Tenesmus	Obstruction
Constipation	Stricture	Perforation
Pain	Fistula	Hemorrhage
Obstipation	Wall Changes	Tissue Hypoxia
Ulceration
EXCLUSION CRITERIA Patients, who are pregnant or have any of the following illnesses, conditions or requirement: Pregnancy Reactive airway disease Radiographic evidence of pulmonary blebs or bullae Untreated pneumothorax Previously documented ejection fraction less than 35% History of seizures — except childhood febrile seizures Cardiovascular instability Mechanical ventilator support Unable to follow simple commands Not orientated to person, place, time Participating as a subject in any other medical or biomedical research project — if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent

HORTIS VI - Gynecologic Radionecrosis
INCLUSION CRITERIA Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria:
Endarteritis	Hypocellularity	Hypovascularity
Vascular Congestion	Ulceration	Persistent Drainage
Necrosis	Hemorrhage	Delayed Healing
Pain	Rectrovaginal Fistula	Vesicovaginal Fistula
Tissue Hypoxia	Necrosis
EXCLUSION CRITERIA Patients, who are pregnant or have any of the following illnesses, conditions or requirement: Pregnancy Reactive airway disease Radiographic evidence of pulmonary blebs or bullae Untreated pneumothorax Previously documented ejection fraction less than 35% History of seizures — except childhood febrile seizures Cardiovascular instability Mechanical ventilator support Unable to follow simple commands Not orientated to person, place, time Participating as a subject in any other medical or biomedical research project — if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent

HORTIS VII - Laryngeal Radionecrosis
INCLUSION CRITERIA Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria:
Endarteritis	Hypocellularity	Hypovascularity
Vascular Congestion	Telangiectasis	Edema
Pain	Fistula	Hoarseness
Odyrophagia	Persistent Cough	Airway Obstruction
Airway Compromise	Erythema	Necrosis
Cord Fixation	Tissue Hypoxia	Cord Motility Impairment
EXCLUSION CRITERIA Patients, who are pregnant or have any of the following illnesses, conditions or requirement: Pregnancy Reactive airway disease Radiographic evidence of pulmonary blebs or bullae Untreated pneumothorax Previously documented ejection fraction less than 35% History of seizures — except childhood febrile seizures Cardiovascular instability Mechanical ventilator support Unable to follow simple commands Not orientated to person, place, time Participating as a subject in any other medical or biomedical research project — if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent

HORTIS VIII - Prophylaxis

INCLUSION CRITERIA
Patients whose cancer treatment included radiotherapy and who are at risk for post-operative healing complications, manifesting as one or more of the medical history or diagnostic criteria listed below:

High risk for radiation tissue injury/healing complications:

5,000 cGy (50 Gray or 5,000 rads) radiotherapy and greater than 6 months from completion of radiotherapy

tissue hypoxia
~ transcutaneous oximetry recorded below 40 mmHg within the previous radiation portal.

EXCLUSION CRITERIA
Patients, who are pregnant or have any of the following illnesses, conditions or requirement:

Pregnancy
Ulceration within the previously irradiated field/planned surgical site
Reactive airway disease
Radiographic evidence of pulmonary blebs or bullae
Untreated pneumothorax
Ejection fraction less than 35%
History of seizures — except childhood febrile seizures
Cardiovascular instability
Mechanical ventilator support
Unable to follow simple commands
Not orientated to person, place, time
Participating as a subject in any other medical or biomedical research project — if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent