Olanzapine to prevent appetite loss during chemoradiation for head and neck cancer
Managing Anorexia During Chemoradiation With Olanzapine (MACRO)
This trial tests whether adding olanzapine to usual symptom care can help prevent appetite loss and weight loss in adults receiving chemoradiation for head and neck cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06995508 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with biopsy-proven head and neck squamous cell carcinoma who are eligible for curative-intent chemoradiation, have ECOG performance status ≤2, and can swallow and retain oral medication are ideal candidates.
Not a fit: Patients who cannot take oral medication, who are not receiving curative-intent chemoradiation, or who have contraindications to olanzapine are unlikely to gain benefit from this trial.
Why it matters
Potential benefit: If successful, adding olanzapine could reduce appetite loss and weight loss during treatment and may lower opioid use, feeding tube need, and hospitalization rates.
How similar studies have performed: Olanzapine has shown benefit for chemotherapy-related nausea and vomiting in other studies, but using it specifically to prevent anorexia and weight loss during head and neck chemoradiation is relatively novel and being tested here.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Anurag K Singh — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.