Olanzapine for Anorexia in Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Must not be taking: Atypical antipsychotics, Steroids

Disqualifiers: Feeding tube, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding olanzapine, a medication typically used for mental health, can help manage appetite loss in patients with head and neck cancer undergoing chemoradiation therapy. The study compares standard symptom care alone to standard care plus olanzapine to determine if it better manages nausea and reduces weight loss. Patients with head and neck cancer receiving chemotherapy and radiation, who can swallow pills, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take Symbyax or use regular systemic steroids or atypical antipsychotics. Other medications like certain anti-nausea drugs are allowed.

Is there any evidence suggesting that olanzapine is likely to be safe for humans?

Research has shown that olanzapine, the treatment tested in this trial, is generally safe and well-tolerated. One study found that a low dose of olanzapine was safe and effective for managing cancer-related anorexia. Another study demonstrated that olanzapine helped patients gain weight, with many gaining more than 5% of their starting weight.

Olanzapine is already approved for treating mental health conditions, so its safety is well-known for those uses. Doctors have extensive experience with it, although it is being studied here for a new purpose. So far, trials for cancer-related anorexia have reported no serious safety issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anorexia?

Unlike the standard treatments for anorexia in head and neck cancer, which typically focus on symptom management, olanzapine offers a new approach by targeting neurotransmitters in the brain. Researchers are excited about olanzapine because it has the potential to improve appetite and reduce nausea, which are significant issues for these patients. By using olanzapine alongside the standard of care, there is hope for better overall outcomes in managing the nutritional challenges faced by patients undergoing cancer treatment.

What evidence suggests that olanzapine might be an effective treatment for anorexia in head and neck cancer?

Research has shown that olanzapine can help cancer patients increase their food intake and manage weight loss. In one study, patients taking olanzapine ate more food just three days after starting the treatment. Another study found that 60% of patients taking olanzapine gained more than 5% of their starting weight, compared to only 9% of those who did not take it. In this trial, participants in one arm will receive olanzapine alongside standard care to evaluate its effectiveness in managing loss of appetite in patients undergoing chemotherapy, including those with head and neck cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

Anurag K Singh

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for head and neck cancer patients experiencing anorexia during chemoradiation therapy. It's designed to help those who suffer from nausea, pain, and difficulty with speaking, swallowing, and eating due to their treatment.

Inclusion Criteria

I can do most activities, but I might be limited in some.

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

My doctor agrees I can have chemotherapy, preferably with platinum.

Exclusion Criteria

Known hypersensitivity to olanzapine

Pregnant or nursing female participants

Unwilling or unable to follow protocol requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation Treatment

Patients receive chemoradiation therapy (CRT) with or without olanzapine for managing anorexia and other symptoms

10 weeks

Weekly visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Olanzapine

Trial Overview

The MACRO Trial is testing if adding Olanzapine—a drug typically used for mental disorders—to the usual care for managing nausea can better control appetite loss in these patients compared to standard care alone.

How Is the Trial Designed?

Group I: Arm II (olanzapine, standard of care) Experimental Treatment 3 Interventions

Starting day 1 of CRT, patients receive olanzapine PO QD for up to 10 weeks after completion of CRT in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care symptom management on study per the discretion of the treating institution.

Group II: Arm I (standard of care) Active Control 2 Interventions

Patients receive standard of care symptom management on study per the discretion of the treating institution.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06995508?term=AREA%5BConditionSearch%5D(%22Squamous%20Cell%20Carcinoma%22)%20AND%20AREA%5BInterventionSearch%5D(%22Psychotropic%20Drugs%22)&rank=5

Olanzapine for Managing Anorexia in Head and Neck ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6433113/

Low-dose of olanzapine has ameliorating effects on cancer ...

In our study, the average of all patients' food intake significantly increased in the 3 days after starting OLZ treatment, even in cancer ...

3.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-03335

Olanzapine for Managing Anorexia in Head and Neck ...

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 ...

4.

ascopubs.org

ascopubs.org/do/olanzapine-chemotherapy-related-anorexia

Podcast: Olanzapine for Chemotherapy-Related Anorexia

And olanzapine in our trial improved weight more than 5% from baseline in 60% of the patients in the olanzapine group and 9% in the placebo.

5.

healio.com

healio.com/news/hematology-oncology/20230504/olanzapine-effective-for-chemotherapyrelated-anorexia-among-patients-with-certain-cancers

Olanzapine effective for chemotherapy-related anorexia ...

Low-dose olanzapine significantly improved appetite and weight gain among patients with newly diagnosed cancer undergoing chemotherapy, according to study ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06995508?cond=%22Head%20and%20Neck%20Cancer%22&intr=%22Serotonin%22&viewType=Table&rank=5

Olanzapine for Managing Anorexia in Head and Neck ...

A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...

7.

withpower.com

withpower.com/trial/olanzapine-for-anorexia-in-head-and-neck-cancer-de98c

Olanzapine for Anorexia in Head and Neck Cancer

Prior Safety DataThis treatment has passed at least one previous human trial ... These side effects have been shown to increase weight loss, opiate use and ...