1. Regularly Scheduled Artificial (IV) Hydration among Head and Neck Cancer Patients Undergoing Radiotherapy-based Treatment By Jessica Mooney With special thanks to: Melanie Gillingham Phd, RD, Dr. John Holland, Sonja Connors PhD, RD, and Shannon Rentz, RD

2. Specific Aim  Effect of regular artificial hydration on the number of admissions for clinical dehydration, and markers of nutritional status in head and neck cancer patients.  Between the OHSU patients who received regularly scheduled IV artificial hydration, with the OHSU patients who received current standard of care

3. Importance  Cancer  Statistics of HNC  Risk Factors  Delays in Treatment

4. Background-Treatment  Radiation 50% of all cancer patients How Radiation Works Intensity modulated radiation treatment (IMRT) ○ 58% still suffer ○ Most cost effective treatment http://svroa.com/services

5. Background-Treatment  Chemotherapy How Chemotherapy Works ○ Toxicities  Combined Chemoradiation New Trend Disease-specific survival rates, and loco regional control.

6. Hospitalizations and Side Effects  Malnourished prior to treatment  Hospitalizations Mucositis Hematologic toxicity Toxicity-related treatment delays ○ Of these hospitalizations  Concomitant chemotherapy and radiation

7. Delays in Treatment  Delays in treatment: Outpatient treatment Increase of total dose  Toxicities Salivary flow Renal function Mucositis  Prevalence of breaks and effects on treatment

8. Cost  Treatment of cancer significant cost $95,000 (AU) per annum for cancer treatment and preventing severe side effects  Average cost All grades of oral mucositis=$6000 per patient ○ Grade 1-2 = $1700 per patient per visit ○ Grade 3-4 = $3600 per patient per visit.

9. Cost  Most cost efficient method or treatment. Surgery Radiation Chemotherapy.  These costs cause financial burdens for both the patient and the healthcare facility.

10. Modes of Artificial Hydration  Hydration and nutritional status  Dehydration can cause fatigue, lethargy, nausea, vomiting, confusion, muscle cramps, and perhaps increased mortality rates.  Determining Hydration Status  Modes of Artificial Hydration Parenteral Fluids Enteral Fluids Hypodermoclysis

11. Quality of Life  Quality of life (QOL) Physical vs. Psychological Social Event  Questionnaires for QOL in HNC Survey short and to the point Qualitative observations  Other Benefits of QOL surveys

12. Methods General Overview  Oregon Health and Science University (OHSU)  Retrospective chart review Comparing: ○ Patients before August 2011 ○ Patients after August 2011

13. Methods-Inclusion/Exclusion  Table 3: Inclusion and exclusion criteria InclusionExclusion >18 years old<18 years old Diagnosis of Head and neck cancer Diagnosis other then head and neck cancer Combination treatment (surgical and radiation) Chemotherapy, radiation, or surgical only treatment Patient at OHSU either prior to August 2011 or after August 2011

14. Current Standard of Care  Patients at OHSU currently  After August 2011 Artificial hydration at emergency department or when severely dehydrated.

15. Historical Standard of Care  Before August 2011  OHSU patients received regularly scheduled IV artificial hydration

16. Methods-Retrospective  60 OHSU patients treated with regularly scheduled artificial hydration  45 OHSU patients treated with current standard of care  The EPIC electronic medical records will be queried using the tumor registry

17. Power Calculations  Primary outcomes of interest Two-sided significance level of 0.05.  The mean number of hospitalizations (number of emergency department visits) anticipation Supported by Elting et al (2007) ○ average of 0.62 visits per patient over the treatment cycle.  Sample of 60 patients under the routine hydration protocol and 45 patients under the newer (no routine hydration) Provides an 80% chance of detecting at least an 85% increase in the mean number of visits (Wald test; increase from 0.6 to 1.1 visits).  BUN expectations of initial lab concentrations Correlation between initial and final BUN is expected to be fairly weak (about 0.20). 80% power to detect mean changes of at least 2.4 mg/dL relative to baseline within either group, with the minimal effect being even smaller for the sample of 60 subjects under the older treatment protocol.

18. Methods-Retrospective  The retrospective chart review will compare: unplanned hospital visits Treatment breaks Number of times clinical hydration is administered Registered Dietitian exposure during treatment

19. Methods  Standards Set Key outcomes  Outside of Ranges will be considered Unacceptable Detrimental to treatment

20. Methods-Retrospective VariablesAcceptable Ranges BUN7-25 mg/dL Creatinine0.7-1.4 mg/dL Hbg12-18 mg/dL Hct37-54% Unplanned Hospital Visits0 visits Weight Loss Throughout Treatment Weight loss less than 10% in 6 months Breaks in Treatment0-5 days

21. Statistical Methods  Calculations Means and standard deviations  These values will be performed using SPSS software.

22. Analytical Statistics  Comparisons between Historical OHSU patient population that received routine hydration Recent HNC patients who did not receive routine hydration  T-test Values <0.05 considered statistically significant  T-tests to compare our primary and secondary outcomes Following slides

23. Exploratory Statistics  Correlation between weight loss with treatment, renal function and treatment outcomes  Goal: to evaluate if preventing weight loss or providing regular hydration treatment decreases hospitalizations during treatment or treatment breaks.

24. Statistical Methods  Statistics conducted to prove or disprove: Number of Hospitalizations BUN/Creatinine Levels  Correlates with number of clinical hydration appointments made  Reject or support hypothesis

25. Key Outcomes PRIMARY OUTCOMES Number of HospitalizationsBUN/Creatinine Serum Values SECONDARY OUTCOMES Breaks in TreatmentWeight loss throughout treatment Serum HemoglobinSerum Hematocrit Administration of Hydration (scheduled/unscheduled) Nutrition Counseling by Registered Dietitian

26. Conclusion  Focus of Treatment Better coordination of care Symptom management Promotion of more cost effective treatments  Avoiding adverse affects that often accompany HNC and it’s treatment

27. Regularly Scheduled Artificial Hydration among Head and Neck Cancer Patients Undergoing Radiotherapy-based Treatment By Jessica Mooney