Back to results

Nutrition and Pharmacological Algorithm for Oncology Patients Study

Primary Purpose

Oncologic Complications, Quality of Life, Nutrition Poor

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Dronabinol

Mirtazapine

Nutrition Intervention

About this trial

This is an interventional supportive care trial for Oncologic Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patient <18 years old
Contraindication to appetite stimulants

Sites / Locations

Montefiore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patients with fair to good appetite

Patients with poor to fair appetite

Arm 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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Quality of Life/Appetite Assessment

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.

Full Information

NCT ID

NCT04155008

First Posted

October 31, 2019

Last Updated

October 24, 2022

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04155008

Brief Title

Nutrition and Pharmacological Algorithm for Oncology Patients Study

Official Title

Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With Anorexia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Terminated

Why Stopped

The trial was closed after 4 months due to slow to accrual. Only 1 participant was enrolled.

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

April 5, 2021 (Actual)

Study Completion Date

April 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with fair to good appetite

Arm Type

Active Comparator

Arm Description

Arm Title

Patients with poor to fair appetite

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dronabinol

Other Intervention Name(s)

Marinol

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Mirtazapine

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Nutrition Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Quality of Life Assessment

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Quality of Life/Appetite Assessment

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Patient <18 years old Contraindication to appetite stimulants

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Justin Tang, MD

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montefiore Hospital

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28988837

Citation

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.

Results Reference

background

PubMed Identifier

18942661

Citation

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.

Results Reference

background

PubMed Identifier

25250951

Citation

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.

Results Reference

background

PubMed Identifier

12969512

Citation

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.

Results Reference

background

PubMed Identifier

25533806

Citation

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.

Results Reference

background

PubMed Identifier

27179893

Citation

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.

Results Reference

background

PubMed Identifier

23608722

Citation

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.

Results Reference

background

PubMed Identifier

28825869

Citation

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.

Results Reference

background

PubMed Identifier

27328311

Citation

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.

Results Reference

background

PubMed Identifier

15920748

Citation

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.

Results Reference

background

PubMed Identifier

15226773

Citation

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.

Results Reference

background

Learn more about this trial

Nutrition and Pharmacological Algorithm for Oncology Patients Study

We'll reach out to this number within 24 hrs