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OP RSH PRO00037695 / HN009 / ARM 2 AND 4	

Types:      Research Oncology Treatment
Synonyms:  HN009

Cycles 1 to 7	Repeat 7 times	Cycle length: 7 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Evaluation
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
·       If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Radiation Therapy
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiation Therapy
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	- Plasma 

During RT at 10-14 fractions (20-28 Gy)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	- Serum

Post-RT: Within 4 weeks from end of RT
			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	include ANC, platelets, Hgb
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	include total bilirubin, AST, ALT, creatinine
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Treatment Hold Parameters: 
·        Chemotherapy must not be administered until the ANC is >= 1200 mm3 and platelets are > = 75,000 mm3.
·        Cisplatin must not be administered until creatinine is <= 1.5 mg/dL or creatinine clearance> = 50 mL/min.
			Nursing Orders
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	The use of hematologic growth factors for neutropenia or anemia are not allowed during concurrent cisplatin and radiation treatment.
			Pre-Hydration
  	sodium chloride 0.9 % infusion	Dose: 500 mL	Route: intravenous	once @ 500 mL/hr for 1 dose						Pre-Medications
  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S				  	palonosetron solution 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S				  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S					Chemotherapy
  	CISplatin (PLATINOL) 40 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 40 mg/m2	Route: intravenous	once over 1 Hours for 1 dose			Offset: 2 Hours	Instructions:	The first cisplatin infusion should be started within 24 hours before or after the first scheduled radiation treatment. Cisplatin should be administered on Mondays or Tuesdays to maximize overlap of daily radiation with cisplatin exposure. Administration on Wednesday prior to that day's radiation dose is acceptable, but not preferred	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CISPLATIN 1 MG/ML INTRAVENOUS SOLUTION	Medications	40 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes				Post-Hydration
  	sodium chloride 0.9 % infusion	Dose: 500 mL	Route: intravenous	once @ 500 mL/hr for 1 dose			Offset: 3 Hours			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once PRN	Start: S				  	acetaminophen (TYLENOL) tablet 500 mg	Dose: 500 mg	Route: oral	once PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
					
EOT	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
·       If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	NSAID use 
-Until year 5
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Patient-Reported Outcomes
• FACT-H&N
• HHIA-S 

At 3, 6, 12, and 24 months
					
FUP	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
·       If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	NSAID use 
-Until year 5
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Patient-Reported Outcomes
• FACT-H&N
• HHIA-S 

At 3, 6, 12, and 24 months
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	-CT scan of neck OR MRI of the neck OR FDG-PET/CT of the neck 

-At 3 months then  AS CLINICALLY INDICATED
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Audiogram