Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Eligible for palliative-intent radiation therapy only

Patients with a feeding tube

Regular systemic steroid use

Atypical antipsychotic use

Trial design

Treatments tested in this trial

  • Best Practice
  • Olanzapine
  • Questionnaire Administration

Treatment groups

66 Participants
are divided into 2 treatment groups

Sponsors and collaborators