Nutrition and Pharmacological Algorithm for Oncology Patients Study

Phase 4TerminatedNCT04155008

Montefiore Medical Center1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

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

Interventions

DexamethasoneDRUG

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.

DronabinolDRUG

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.

MirtazapineDRUG

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.

Nutrition InterventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with a diagnosis of head/neck, lung, pancreatic cancer, or metastatic cancer from any solid tumor 2. Planned, ongoing, or recently treated patient (within the past 30 days) with chemotherapy, immunotherapy, and/or intravenous targeted biologic therapy 3. No previous use of appetite stimulants 4. All patients must sign study specific informed consent prior to being included in the study 5. No contraindication to appetite stimulants Exclusion Criteria: 1. Patient \<18 years old 2. Contraindication to appetite stimulants

Outcomes

Primary Outcomes

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).

Time frame: 3 months

Secondary Outcomes

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.