Regularly Scheduled Artificial (IV) Hydration among Head and Neck Cancer Patients

Undergoing Radiotherapy-based Treatment

By Jessica MooneyWith special thanks to: Melanie Gillingham Phd, RD, Dr. John Holland, Sonja Connors PhD, RD, and Shannon

Rentz, RD

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

Importance Cancer

Statistics of HNC Risk Factors

Delays in Treatment

Background-Treatment Radiation

50% of all cancer patients

How Radiation WorksIntensity modulated

radiation treatment (IMRT)○ 58% still suffer○ Most cost effective

treatment

http://svroa.com/services

Background-Treatment Chemotherapy

How Chemotherapy Works○ Toxicities

Combined ChemoradiationNew TrendDisease-specific

survival rates, and loco regional control.

Hospitalizations and Side Effects Malnourished prior to treatment Hospitalizations

Mucositis Hematologic toxicity Toxicity-related treatment delays

○ Of these hospitalizations

Concomitant chemotherapy and radiation

Delays in Treatment

Delays in treatment:Outpatient treatmentIncrease of total dose

ToxicitiesSalivary flow Renal functionMucositis

Prevalence of breaks and effects on treatment

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.

Cost Most cost efficient

method or treatment. SurgeryRadiationChemotherapy.

These costs cause financial burdens for both the patient and the healthcare facility.

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 FluidsEnteral FluidsHypodermoclysis

Quality of Life

Quality of life (QOL)Physical vs. Psychological Social Event

Questionnaires for QOL in HNCSurvey short and to the pointQualitative observations

Other Benefits of QOL surveys

Methods General Overview Oregon Health and Science University

(OHSU)

Retrospective chart review Comparing:

○ Patients before August 2011○ Patients after August 2011

Methods-Inclusion/Exclusion Table 3: Inclusion and exclusion criteria

Inclusion Exclusion>18 years old <18 years oldDiagnosis of Head and neck cancer Diagnosis other then head and neck

cancerCombination treatment (surgical and radiation)

Chemotherapy, radiation, or surgical only treatment

Patient at OHSU either prior to August 2011 or after August 2011

Current Standard of Care Patients at OHSU

currently

After August 2011Artificial hydration at

emergency department or when severely dehydrated.

Historical Standard of Care

Before August 2011

OHSU patients received regularly scheduled IV artificial hydration

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

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.

Methods-Retrospective The retrospective

chart review will compare: unplanned hospital

visitsTreatment breaksNumber of times

clinical hydration is administered

Registered Dietitian exposure during treatment

Methods Standards Set

Key outcomes

Outside of Ranges will be consideredUnacceptableDetrimental to

treatment

Methods-Retrospective

Variables Acceptable Ranges

BUN 7-25 mg/dL

Creatinine 0.7-1.4 mg/dL

Hbg 12-18 mg/dL

Hct 37-54%

Unplanned Hospital Visits 0 visits

Weight Loss Throughout Treatment

Weight loss less than 10% in 6 months

Breaks in Treatment 0-5 days

Statistical Methods Calculations

Means and standard deviations

These values will be performed using SPSS software.

Analytical Statistics

Comparisons betweenHistorical 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

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.

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

Key OutcomesPRIMARY OUTCOMES

Number of Hospitalizations BUN/Creatinine Serum Values

SECONDARY OUTCOMES

Breaks in Treatment Weight loss throughout treatment

Serum Hemoglobin Serum Hematocrit

Administration of Hydration (scheduled/unscheduled)

Nutrition Counseling by Registered Dietitian

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

Regularly Scheduled Artificial Hydration among Head and Neck Cancer Patients

Undergoing Radiotherapy-based Treatment

By Jessica Mooney