Nutrition and Pharmacological Algorithm for Oncology Patients Study

Montefiore Medicine Academic Health System

Status and phase: Terminated; Phase 4

Conditions: Quality of Life; Lung Cancer; Head and Neck Cancer; Oncologic Complications; Pancreatic Cancer; Nutrition Poor

Treatments: Drug: Dexamethasone; Drug: Dronabinol; Drug: Mirtazapine; Behavioral: Nutrition Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04155008

2019-10218

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1 participants in 2 patient groups

Patients with fair to good appetite

Active Comparator group

Description:

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

Treatment:

Behavioral: Nutrition Intervention

Patients with poor to fair appetite

Experimental group

Description:

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

Treatment:

Drug: Mirtazapine

Behavioral: Nutrition Intervention

Drug: Dronabinol

Drug: Dexamethasone