NCT06995508 Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial
| NCT ID | NCT06995508 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Cancer-Associated Anorexia |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-12-24 |
| Primary Completion | 2030-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 66 participants in total. It began in 2025-12-24 with a primary completion date of 2030-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Eligible for palliative-intent radiation therapy only * Patients with a feeding tube * Regular systemic steroid use * 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 * 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 * Pregnant or nursing female participants * Known history of seizures * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Contact & Investigator
Anurag K Singh
PRINCIPAL INVESTIGATOR
Roswell Park Cancer Institute
Frequently Asked Questions
Who can join the NCT06995508 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer-Associated Anorexia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06995508 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06995508 currently recruiting?
Yes, NCT06995508 is actively recruiting participants. Visit ClinicalTrials.gov or contact Roswell Park Cancer Institute to inquire about joining.
Where is the NCT06995508 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT06995508 clinical trial?
NCT06995508 is sponsored by Roswell Park Cancer Institute. The principal investigator is Anurag K Singh at Roswell Park Cancer Institute. The trial plans to enroll 66 participants.
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