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Nutrition and Pharmacological Algorithm for Oncology Patients Study

Sponsor
Montefiore Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT04155008
Collaborator
(none)
1
Enrollment
1
Location
2
Arms
1.1
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With Anorexia
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Apr 5, 2021
Actual Study Completion Date :
Apr 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Patients with fair to good appetite

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

Behavioral: 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
Experimental: Patients with poor to fair appetite

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.

Drug: Dexamethasone
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.

Drug: 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 (which is FDA approved) 2.5mg, twice daily before meals.
Other Names:
  • Marinol

    • Drug: 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 (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.

    Behavioral: 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

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life Assessment [3 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

    1. Quality of Life/Appetite Assessment [3 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Montefiore Hospital Bronx New York United States 10467

    Sponsors and Collaborators

    • Montefiore Medical Center

    Investigators

    • Principal Investigator: Justin Tang, MD, Montefiore Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT04155008
    Other Study ID Numbers:
    • 2019-10218
    First Posted:
    Nov 7, 2019
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Malnutrition
    Dexamethasone
    Dronabinol
    Mirtazapine

    Study Results

    No Results Posted as of Apr 4, 2022