NCT06995508RecruitingPhase 2
Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial
Managing Anorexia During Chemoradiation With Olanzapine (MACRO)
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
This phase II trial compares the effect of adding olanzapine to standard of care symptom management for nausea to standard of care alone in managing an abnormal loss of the appetite for food (anorexia) in patients treated with chemoradiation therapy (CRT) for head and neck cancer. Patients undergoing CRT may experience treatment-related side effects, including pain, nausea, and a discomfort in the ability to speak, swallow and eat. These side effects have been shown to increase weight loss, opiate use and hospitalization. Olanzapine is a drug used to treat certain mental disorders. It is also being studied in the treatment of nausea and vomiting caused by some cancer treatments. It is a type of anti-psychotic and a type of monoamine antagonist. Adding olanzapine to standard of care symptom management to limit nausea may be more effective than standard of care alone in managing anorexia in head and neck cancer patients during CRT.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 12 May 2025
- Start date
- 24 Dec 2025
- Primary completion date
- 15 Nov 2030
- Lead sponsor
- Roswell Park Cancer Institute
- Diseases
- Head and neck cancer
- NCT number
- NCT06995508
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 66
- From 24 Dec 2025 to the primary completion date, 15 Nov 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Eligible for palliative-intent radiation therapy only
- Regular systemic steroid use
Other illness
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes or psychiatric illness/social situations that would limit compliance with study requirements
- Known hypersensitivity to olanzapine
- Known history of seizures
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Other
- Patients with a feeding tube
- Atypical antipsychotic use
- Other dopamine receptor blockers routinely used as anti-emetics (eg. prochlorperazine/compazine and metoclopramide) are allowed to be prescribed as usual care on this study
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
Who the study is looking for
- Age ≥ 18 years old
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Diagnosed with biopsy-proven, squamous cell carcinoma of the head and neck, including squamous cell carcinoma of the neck with unknown primary site
- Eligible for curative-intent chemoradiation therapy of the head and neck
- Patients must be eligible for concurrent systemic therapy (preferably platinum based) as determined by the treating medical oncologist to undergo platinum-based chemotherapy
- Ability to swallow and retain oral medication
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participants must agree to avoid the following while taking Olanzapine while they are on study:
- Taking the drug Symbyax (which already contains olanzapine)
- Consuming alcohol
- Operating hazardous machinery, including automobiles, until you are reasonably certain that the study drug therapy does not have any bad effects on your mental and physical health
- Participant must understand the investigational nature of this study and sign an institutional review board approved written informed consent form prior to receiving any study related procedure
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.