Oncologic ComplicationsPhase 4NCT04155008

Nutrition and Pharmacological Algorithm for Oncology Patients Study

A Phase 4 study testing Dexamethasone, Dronabinol and Mirtazapine in people with Oncologic Complications and Quality of Life, run by Montefiore Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oncologic Complications, Quality of Life, Nutrition Poor
What is being tested?: Dexamethasone, Dronabinol and Mirtazapine
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2021to 5 Apr 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Patient <18 years old
Contraindication to appetite stimulants

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Hospital
The Bronx, New York, 10467

Other trials in United States

About this study

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

Conditions: Oncologic Complications, Quality of Life, Nutrition Poor, Head and Neck Cancer, Lung Cancer, Pancreatic Cancer
Being tested: Dexamethasone, Dronabinol, Mirtazapine, Nutrition Intervention
Medical subject headings: Malnutrition, Head and Neck Neoplasms, Lung Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamethasoneDrug
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.
DronabinolDrug
Also called Marinol
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.
MirtazapineDrug
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.
Nutrition InterventionBehavioural
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

Study groups in NCT04155008
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Dexamethasone; Drug: Dronabinol; Drug: Mirtazapine; Behavioral: Nutrition Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 3 months

Secondary outcomes (1)

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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20215 Apr 2021

First posted7 Nov 2019
Study start1 Mar 2021
Primary completion5 Apr 2021
Study completion5 Apr 2021

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Oncologic ComplicationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04155008
Sponsor's protocol ID: 2019-10218
Other IDs: 2019
Status last verified: Oct 2022
First submitted: 31 Oct 2019
Last updated: 16 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28988837
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.
PubMed 18942661
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.
PubMed 25250951
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.
PubMed 12969512
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.
PubMed 25533806
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.
PubMed 27179893
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.
PubMed 23608722
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.
PubMed 28825869
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.
PubMed 27328311
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.
PubMed 15920748
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.
PubMed 15226773

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With Anorexia
ClinicalTrials.gov ID: NCT04155008
Acronym / sponsor ID: 2019-10218
Conditions: Oncologic Complications, Quality of Life, Nutrition Poor, Head and Neck Cancer, Lung Cancer, Pancreatic Cancer
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial was closed after 4 months due to slow to accrual. Only 1 participant was enrolled.
Enrolment: 1 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: 1 Mar 2021 (actual)
Primary completion: 5 Apr 2021 (actual)
Study completion: 5 Apr 2021 (actual)
First posted: 7 Nov 2019 (actual)
Results: Posted 16 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Patients with fair to good appetite	Active comparator	Behavioral: Nutrition InterventionThe 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
Patients with poor to fair appetite	Experimental	Drug: Dexamethasone, Drug: Dronabinol, Drug: Mirtazapine, Behavioral: Nutrition InterventionThe 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

Patient <18 years old
Contraindication to appetite stimulants

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexamethasoneIf 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	Patients with poor to fair appetite
DronabinolAlso: MarinolIf 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	Patients with poor to fair appetite
MirtazapineIf 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.	Drug	Patients with poor to fair appetite
Nutrition InterventionNutrition 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	Behavioural	Patients with fair to good appetite, Patients with poor to fair appetite

Primary outcome

Quality of Life Assessment
Time frame: 3 months
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).

1 secondary outcome

Quality of Life/Appetite Assessment
Time frame: 3 months

Results and safety

Results posted to the registry on 16 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Fair to Good Appetite	0	0
Patients With Poor to Fair Appetite	1	1

Primary outcome: Quality of Life Assessment

Time frame: 3 months

Population analysed: Only 1 patient was enrolled into the study prior to termination. This patient was enrolled into the 'Patients with poor to fair appetite' arm based on their CNAQ score. Data were not collected.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Fair to Good Appetite	0 of 0	0 of 0	0
Patients With Poor to Fair Appetite	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28988837Swan 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.
Background: PubMed 18942661Janda 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.
Background: PubMed 25250951Doll 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.
Background: PubMed 12969512Dapueto 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.
Background: PubMed 25533806Sim 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.
Background: PubMed 27179893Alvarez-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.
Background: PubMed 23608722Holm 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.
Background: PubMed 28825869Mattox TW. Cancer Cachexia: Cause, Diagnosis, and Treatment. Nutr Clin Pract. 2017 Oct;32(5):599-606. doi: 10.1177/0884533617722986. Epub 2017 Aug 21.
Background: PubMed 27328311Cox 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.
Background: PubMed 15920748Ravasco 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.
Background: PubMed 15226773Isenring 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Justin Tang, MD principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone, Dronabinol and Mirtazapine in people with Oncologic Complications and Quality of Life, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life Assessment (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04155008, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.