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

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anurag K Singh

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+