Could a common drug help cancer patients keep their appetite?
NCT ID NCT06995508
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether adding olanzapine to standard care helps manage appetite loss in head and neck cancer patients undergoing chemoradiation. About 66 adults will receive either olanzapine plus standard symptom management or standard care alone. The main goal is to see if olanzapine helps patients maintain weight during treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Olanzapine
- What this could lead to
- If it works, this could offer a way to reduce weight loss and improve appetite during cancer treatment.
- What could go wrong
- This is a small, early-phase trial, so results may not apply broadly. Olanzapine can cause side effects like drowsiness or metabolic changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NeoRTPC02): an open label, single-arm, phase II clinical trial
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- Can a new pill boost Immunotherapy's power against advanced tumors?
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- Blood test may reveal hidden cancer cells in head and neck tumors