Nutrition and Pharmacological Algorithm for Oncology Patients Study

Study Overview
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Brief Summary
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Loss of appetite is a common symptom of patients with cancer and can cause distress which impacts patients and caregivers. Patients diagnosed with head/neck, lung or pancreatic cancer will be recruited for this study to decrease the suffering and distress associated with eating during cancer treatment and improve the quality of life of patients by implementing an algorithm utilizing nutrition intervention and appetite stimulants.

Official Title
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Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With Anorexia

Conditions
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Oncologic Complications, Quality of Life, Nutrition Poor, Head and Neck Cancer, Lung Cancer, Pancreatic Cancer

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Dronabinol
* Drug: Mirtazapine
* Behavioral: Nutrition Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of head/neck, lung, pancreatic cancer, or metastatic cancer from any solid tumor Planned, ongoing, or recently treated patient (within the past 30 days) with chemotherapy, immunotherapy, and/or intravenous targeted biologic therapy No previous use of appetite stimulants All patients must sign study specific informed consent prior to being included in the study No contraindication to appetite stimulants Exclusion Criteria: Patient <18 years old Contraindication to appetite stimulants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with fair to good appetite<br>The patients with fair-good appetite (score on CNAQ more than 24) will not receive any pharmacological agents and will receive nutrition intervention alone. CNAQ = Council on Nutrition Appetite Questionnaire | Behavioral: Nutrition Intervention<br>* Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status<br>|
| Experimental: Patients with poor to fair appetite<br>The patients with poor-fair appetite (score on CNAQ less than 24) will be provided nutrition intervention by the Registered Dietitian and then put into one of three pharmacological groups. CNAQ = Council on Nutrition Appetite Questionnaire | Drug: Dexamethasone<br>* If the patient's prognosis is extremely poor (less than 12 weeks expected survival, based on discussion with the patient's treating physicians) and there is no additional disease modifying therapy planned, the patient will be prescribed 4mg dexamethasone (which is FDA approved), once daily, to be taken orally in the morning.<br>Drug: Dronabinol<br>* If the patient has a history of marijuana use or has tried it in the past and had a positive experience with it, then the patient will be prescribed dronabinol (which is FDA approved) 2.5mg, twice daily before meals.<br>* Other names: Marinol;Drug: Mirtazapine<br>* If the patient does not have any history of marijuana use, mirtazapine will be prescribed. If the patient is under the age of 70, then the patient would be prescribed 15mg of mirtazapine (which is FDA approved), once daily, to be taken orally at bedtime. For geriatric population (if the patient is over the age of 70), then the patient would be prescribed 7.5mg of mirtazapine, once daily to be taken orally at bedtime.<br>Behavioral: Nutrition Intervention<br>* Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Assessment | The primary outcome of this study is assessing the impact on quality of life for the oncology patients by using an algorithm for nutrition intervention and appetite stimulants through utilizing Functional Assessment of Cancer Therapy-General Population (FACT-GP). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life/Appetite Assessment | The secondary outcome of this study is assessing the impact on quality of life/appetite for the oncology patients by using an algorithm for nutrition intervention and appetite stimulants through utilizing the Council of Nutrition appetite questionnaire. | 3 months |