Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Pancreatic Neoplasms

Malnutrition

Anorexia

Head and Neck Neoplasms

Nutrition Disorders

Pancreatic Cancer

Quality of Life

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Analgesics

Psychotropic Drugs

Central Nervous System Depressants

Dexamethasone

Dexamethasone acetate

Dronabinol

Mirtazapine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antidepressive Agents

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Anti-Anxiety Agents

Adrenergic Agents

Adrenergic alpha-2 Receptor Antagonists

Adrenergic alpha-Antagonists

Adrenergic Antagonists

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Hallucinogens

Analgesics, Non-Narcotic

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

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

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.

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.

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 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

Nutrition Intervention

Justin Tang, MD

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.

Nutrition and Pharmacological Algorithm for Oncology Patients Study

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

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).

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.

Montefiore Medical Center

This was not a therapeutic trial and as such regular review of study conduct, adverse events, and results by a Data and Safety Monitoring Board (DSMB) was not required, and deaths, serious adverse events, and nonserious adverse events were not assessed for planned study participants. As noted only one participant was enrolled into the study.

The patients with fair-good appetite (score on CNAQ \> 24) will not receive any pharmacological agents and will receive nutrition intervention alone.

Nutrition Intervention: 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

Patients With Fair to Good Appetite

The patients with poor-fair appetite (score on CNAQ \< 24) will be provided nutrition intervention by the Registered Dietitian and then put into one of three pharmacological groups.

Dexamethasone: If the patient's prognosis is extremely poor (\<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 (FDA approved), once daily, to be taken orally in the morning.

Dronabinol: 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 (FDA approved) 2.5mg, twice daily before meals.

Mirtazapine: 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 (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 Intervention: 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

Patients With Poor to Fair Appetite

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Only 1 participant was enrolled in this study.

The primary and secondary outcomes were unable to be assessed as only 1 patient (out of a planned 30) was enrolled into the study. No analyses were therefore conducted.

Dr. Justin Tang

Only 1 patient was enrolled into the study prior to termination. This patient was enrolled into the 'Patients with poor to fair appetite' arm based on their CNAQ score. Data were not collected.

Quality of Life Assessment

Quality of Life/Appetite Assessment

The patients with fair-good appetite (score on CNAQ \> 24) will not receive any pharmacological agents and will receive nutrition intervention alone.

Nutrition Intervention: 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

CNAQ = Council on Nutrition Appetite Questionnaire

Patients with poor-fair appetite (score on CNAQ \< 24) will be provided nutrition intervention by the Registered Dietitian and then put into one of three pharmacological groups.

Dexamethasone: If the patient's prognosis is extremely poor (\<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 (FDA approved), once daily, to be taken orally in the morning.

Dronabinol: 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 (FDA approved) 2.5mg, twice daily before meals.

Mirtazapine: 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 (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 Intervention: 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

Spots Global Cancer Trial Database for Nutrition and Pharmacological Algorithm for Oncology Patients Study

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial