Olanzapine to prevent appetite loss during chemoradiation for head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase II trial that compares standard symptom management alone versus standard symptom management plus daily oral olanzapine starting on day 1 of chemoradiation and continued for up to 10 weeks after treatment. The primary endpoint is prevention of weight loss during chemoradiation, with secondary endpoints including severe weight loss, treatment-related toxicities, quality of life measures (nausea, vomiting, appetite, swallowing, pain, sleep), opioid use, hospitalization, feeding tube use, and chemotherapy delays. Patients are followed through a post-treatment visit at about five weeks. Enrollment is limited to adults with biopsy-proven head and neck squamous cell carcinoma who are eligible for curative-intent chemoradiation and able to swallow oral medication.

Why it matters

Who can join: the full rules

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

Where it's running

• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting

Study contacts

• Principal investigator: Anurag K Singh — Roswell Park Cancer Institute

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Online Sharing for Head & Neck Cancer Support

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• Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

  This study tests a combination treatment to see if it helps people with newly diagnosed recurrent or metastatic head and neck squamous cell carcinoma who express the c-Met protein.

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• Mild heat therapy added to standard treatment for locally advanced head and neck cancer

  This early-stage trial tests whether mild hyperthermia can be safely added to standard radiotherapy with or without chemotherapy for locally advanced head and neck cancer.

  Recruiting Phase 1 Erasmus Medical Center · Rotterdam, South Holland · NCT07690618

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.