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Nutrition and Pharmacological Algorithm for Oncology Patients Study

Phase 4
Terminated
Conditions
Quality of Life
Pancreatic Cancer
Nutrition Poor
Head and Neck Cancer
Lung Cancer
Oncologic Complications
Interventions
Registration Number
NCT04155008
Lead Sponsor
Montefiore Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Patients with fair to good appetiteNutrition InterventionThe 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
Patients with poor to fair appetiteNutrition InterventionThe 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
Patients with poor to fair appetiteDexamethasoneThe 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
Patients with poor to fair appetiteDronabinolThe 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
Patients with poor to fair appetiteMirtazapineThe 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
Primary Outcome Measures
NameTimeMethod
Quality of Life Assessment3 months

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).

Secondary Outcome Measures
NameTimeMethod
Quality of Life/Appetite Assessment3 months

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.

Trial Locations

Locations (1)

Montefiore Hospital

🇺🇸

Bronx, New York, United States

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