Nutrition and Pharmacological Algorithm for Oncology Patients Study

NCT04155008 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2019-10218
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Quality of Life Assessment

  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).

  3 months

Secondary Outcomes (1)

• Quality of Life/Appetite Assessment

  3 months

Study Arms (2)

Patients with fair to good appetite

ACTIVE COMPARATOR

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

Behavioral: Nutrition Intervention

Patients with poor to fair appetite

EXPERIMENTAL

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

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

Interventions

Dexamethasone DRUG

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.

Patients with poor to fair appetite

Dronabinol DRUG

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.

Also known as: Marinol

Patients with poor to fair appetite

Mirtazapine DRUG

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.

Patients with poor to fair appetite

Nutrition Intervention BEHAVIORAL

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

Patients with fair to good appetite; Patients with poor to fair appetite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of head/neck, lung, pancreatic cancer, or metastatic cancer from any solid tumor
• Planned, ongoing, or recently treated patient (within the past 30 days) with chemotherapy, immunotherapy, and/or intravenous targeted biologic therapy
• No previous use of appetite stimulants
• All patients must sign study specific informed consent prior to being included in the study
• No contraindication to appetite stimulants

You may not qualify if:

• Patient \<18 years old
• Contraindication to appetite stimulants

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Hospital

The Bronx, New York, 10467, United States

Location

Related Publications (11)

• Swan WI, Vivanti A, Hakel-Smith NA, Hotson B, Orrevall Y, Trostler N, Beck Howarter K, Papoutsakis C. Nutrition Care Process and Model Update: Toward Realizing People-Centered Care and Outcomes Management. J Acad Nutr Diet. 2017 Dec;117(12):2003-2014. doi: 10.1016/j.jand.2017.07.015. Epub 2017 Oct 5. No abstract available.

  PMID: 28988837 BACKGROUND

• Janda M, DiSipio T, Hurst C, Cella D, Newman B. The Queensland Cancer Risk Study: general population norms for the Functional Assessment of Cancer Therapy-General (FACT-G). Psychooncology. 2009 Jun;18(6):606-14. doi: 10.1002/pon.1428.

  PMID: 18942661 BACKGROUND

• Doll KM, Kalinowski AK, Snavely AC, Irwin DE, Bensen JT, Bae-Jump VL, Kim KH, Van Le L, Clarke-Pearson DL, Gehrig PA. Obesity is associated with worse quality of life in women with gynecologic malignancies: an opportunity to improve patient-centered outcomes. Cancer. 2015 Feb 1;121(3):395-402. doi: 10.1002/cncr.29061. Epub 2014 Sep 23.

  PMID: 25250951 BACKGROUND

• Dapueto JJ, Francolino C, Servente L, Chang CH, Gotta I, Levin R, Abreu Mdel C. Evaluation of the Functional Assessment of Cancer Therapy-General (FACT-G) Spanish Version 4 in South America: classic psychometric and item response theory analyses. Health Qual Life Outcomes. 2003 Aug 20;1:32. doi: 10.1186/1477-7525-1-32.

  PMID: 12969512 BACKGROUND

• Sim BY, Lee YW, Kim H, Kim SH. Post-traumatic growth in stomach cancer survivors: Prevalence, correlates and relationship with health-related quality of life. Eur J Oncol Nurs. 2015 Jun;19(3):230-6. doi: 10.1016/j.ejon.2014.10.017. Epub 2014 Dec 18.

  PMID: 25533806 BACKGROUND

• Alvarez-Camacho M, Martinez-Michel L, Gonella S, Scrimger RA, Chu KP, Wismer WV. Physical symptom burden of post-treatment head and neck cancer patients influences their characterization of food: Findings of a repertory grid study. Eur J Oncol Nurs. 2016 Jun;22:54-62. doi: 10.1016/j.ejon.2016.03.008. Epub 2016 Apr 7.

  PMID: 27179893 BACKGROUND

• Holm T, Maier A, Wicks P, Lang D, Linke P, Munch C, Steinfurth L, Meyer R, Meyer T. Severe loss of appetite in amyotrophic lateral sclerosis patients: online self-assessment study. Interact J Med Res. 2013 Apr 17;2(1):e8. doi: 10.2196/ijmr.2463.

  PMID: 23608722 BACKGROUND

• Mattox TW. Cancer Cachexia: Cause, Diagnosis, and Treatment. Nutr Clin Pract. 2017 Oct;32(5):599-606. doi: 10.1177/0884533617722986. Epub 2017 Aug 21.

  PMID: 28825869 BACKGROUND

• Cox S, Powell C, Carter B, Hurt C, Mukherjee S, Crosby TD. Role of nutritional status and intervention in oesophageal cancer treated with definitive chemoradiotherapy: outcomes from SCOPE1. Br J Cancer. 2016 Jul 12;115(2):172-7. doi: 10.1038/bjc.2016.129. Epub 2016 Jun 21.

  PMID: 27328311 BACKGROUND

• Ravasco P, Monteiro-Grillo I, Marques Vidal P, Camilo ME. Impact of nutrition on outcome: a prospective randomized controlled trial in patients with head and neck cancer undergoing radiotherapy. Head Neck. 2005 Aug;27(8):659-68. doi: 10.1002/hed.20221.

  PMID: 15920748 BACKGROUND

• Isenring EA, Capra S, Bauer JD. Nutrition intervention is beneficial in oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area. Br J Cancer. 2004 Aug 2;91(3):447-52. doi: 10.1038/sj.bjc.6601962.

  PMID: 15226773 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Head and Neck Neoplasms; Lung Neoplasms; Pancreatic Neoplasms

Interventions

Dexamethasone; Dronabinol; Mirtazapine; Diet Therapy

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nutrition Therapy; Therapeutics

Limitations and Caveats

The primary and secondary outcomes were unable to be assessed as only 1 patient (out of a planned 30) was enrolled into the study. No analyses were therefore conducted.

Results Point of Contact

• Title: Dr. Justin Tang
• Organization: Montefiore Medical Center

jtang@montefiore.org

718-920-4094

Study Officials

• Justin Tang, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 7, 2019
• Study Start: March 1, 2021
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: November 16, 2022
• Results First Posted: November 16, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)