Brief Summary
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.
Brief Title
Nutrition and Pharmacological Algorithm for Oncology Patients Study
Categories
Completion Date
Completion Date Type
Actual
Conditions
Oncologic Complications
Quality of Life
Nutrition Poor
Head and Neck Cancer
Lung Cancer
Pancreatic Cancer
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04155008
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10218
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With Anorexia
Primary Outcomes
Outcome Description
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).
Outcome Measure
Quality of Life Assessment
Outcome Time Frame
3 months
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
3 months
Outcome Measure
Quality of Life/Appetite Assessment
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Justin Tang
Investigator Email
jtang@montefiore.org
Investigator Phone
Categories Mesh Debug
Diabetes & Endocrine System --- MALNUTRITION
Endocrine System Cancers --- HEAD AND NECK NEOPLASMS
Lung & Chest Cancers --- LUNG NEOPLASMS
Obesity & Weight Management --- NUTRITION DISORDERS
Cancer --- NEOPLASMS BY SITE
Prostate Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Endocrine System Cancers --- NEOPLASMS
Gastrointestinal (GI) Cancers --- NEOPLASMS
Gynecologic Cancers --- NEOPLASMS
Lung & Chest Cancers --- NEOPLASMS
Prostate Cancer --- NEOPLASMS
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Endocrine System Cancers --- ENDOCRINE GLAND NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Endocrine System Cancers --- ENDOCRINE SYSTEM DISEASES
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
MeSH Terms
MALNUTRITION
HEAD AND NECK NEOPLASMS
LUNG NEOPLASMS
PANCREATIC NEOPLASMS
NUTRITION DISORDERS
NUTRITIONAL AND METABOLIC DISEASES
NEOPLASMS BY SITE
NEOPLASMS
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES
DIGESTIVE SYSTEM NEOPLASMS
ENDOCRINE GLAND NEOPLASMS
DIGESTIVE SYSTEM DISEASES
PANCREATIC DISEASES
ENDOCRINE SYSTEM DISEASES
DEXAMETHASONE
DRONABINOL
MIRTAZAPINE
DIET THERAPY
PREGNADIENETRIOLS
PREGNADIENES
PREGNANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
STEROIDS, FLUORINATED
CANNABINOIDS
TERPENES
HYDROCARBONS
ORGANIC CHEMICALS
DIBENZAZEPINES
HETEROCYCLIC COMPOUNDS, 3-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
HETEROCYCLIC COMPOUNDS
NUTRITION THERAPY
THERAPEUTICS