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OP RESEARCH PRO00030489 HMCC-BR22-001 BASELINE ASSESSMENTS NIRAVATH	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	BIOPSY	Interval: --	Occurrences: --	Comments:	Core biopsy in tumor amenable lesions. All tumors will have tissue collected at baseline for the PIK3CA mutational biomarkers including E545K, E542K, H1047R/Y/L.
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	o if patients have allergy to CT contrast, MRI of the abdomen and pelvis may be substituted for CT scan, and non-contrast CT scan of the chest should be performed scans should be performed within 7 days prior to scheduled visit. 
o Staging performed as standard of care will be used for baseline assessment if performed within 35 days prior to Cycle 1, Day 1.
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	CRC and treatment team to collect  AEs and SAEs from start of treatment, including SAEs related to baseline biopsy only will be recorded until 7 days (for non-serious AEs) or 30 days (for SAEs) and up to 30 days after last treatment dose.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o Provider Alpelisib Rx as appropriate. 
o 250 mg is the starting dose,  
o To be adjusted based on dose limiting toxicities.
			Supportive Care
☐	amLODIPine (NORVASC) 10 mg tablet	Dose: 10 mg	Route: oral	daily	Dispense: --	Refills: --	Start: S			Instructions:	On days 0-5. 
o First dose to occur the night before L-NMMA treatment on Day 1 of all cycles. 
o On L-NMMA infusion days, to be given 30 minutes prior to infusion start time.		☐	aspirin 81 mg chewable tablet	Dose: 81 mg	Route: oral	daily	Dispense: --	Refills: --	Start: S			Instructions:	All cycles for inhibition of activation of prostaglandin pathways.		☐	metFORMIN (GLUCOPHAGE) 500 mg tablet	Dose: 500 mg	Route: oral	daily with breakfast	Dispense: --	Refills: --	Start: S			Instructions:	Initial dose started 1 week prior to chemotherapy treatment date. Completes on Day 1 before dose frequency increase.		☐	metFORMIN (GLUCOPHAGE) 500 mg tablet	Dose: 500 mg	Route: oral	2 times daily with meals	Dispense: --	Refills: --	Start: S			Instructions:	Dose can be increased per treating physician discretion based on subject tolerability and serial blood sugar assessments.		☐	cetirizine (ZyrTEC) 10 MG tablet	Dose: 10 mg	Route: oral	daily	Dispense: --	Refills: --	Start: S			Instructions:	Skin rash prophylaxis