Clinical trial · Interventional
Nutrition and Pharmacological Algorithm for Oncology Patients Study
Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With Anorexia
NCT04155008CI-TRIAL-00062207terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was closed after 4 months due to slow to accrual. Only 1 participant was enrolled.
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Nutrition Poor | — | UNRESOLVED | — |
| Oncologic Complications | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Dronabinol | Drug | — | UNRESOLVED |
| Mirtazapine | Drug | — | UNRESOLVED |
| Nutrition Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Patients with fair to good appetite
- 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
- interventionNames
- Behavioral: Nutrition Intervention
- type
- EXPERIMENTAL
- label
- Patients with poor to fair appetite
- 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
- interventionNames
- Drug: Dexamethasone
- Drug: Dronabinol
- Drug: Mirtazapine
- Behavioral: Nutrition Intervention
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDSwan 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
- BACKGROUNDJanda 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
- BACKGROUNDDoll 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
- BACKGROUNDDapueto 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
- BACKGROUNDSim 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
- BACKGROUNDAlvarez-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.