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Nutrition and Pharmacological Algorithm for Oncology Patients Study

NCT04155008 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-11-16

Study results available
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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.

Conditions

Interventions

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.

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

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Justin Tang, MD · Montefiore Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-04-05
Completion
2021-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04155008 on ClinicalTrials.gov