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Nutrition and Pharmacological Algorithm for Oncology Patients Study

Montefiore Medicine Academic Health System logo

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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