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.
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
Eligible for palliative-intent radiation therapy only
Patients with a feeding tube
Regular systemic steroid use
Atypical antipsychotic use
Parallel
Best Practice
Other interventionGiven standard of care symptom management
Olanzapine
DrugGiven PO
Questionnaire Administration
Other interventionAncillary studies
Average change in weight
Will be summarized by study arm using the mean and standard deviation. A two-sample t-test will be used. All test assumptions will be verified graphically, and transformations or non-parametric approaches will be considered, as appropriate.
Proportion of patients with severe weight loss
Will be defined as \>= 10% body weight loss. Will be summarized by study arm and compared by the Fisher exact test or chi-squared test as appropriate.
Incidence of adverse events
Will be assessed using the Cancer Therapy Evaluation Program National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will be summarized by attribution and grade using frequencies and relative frequencies. Differences in CTCAE rates (grade 2 or higher) will be compared between groups using the Fisher exact Test or chi-Squared test as appropriate.
Change in quality of life (QOL) scores
Will be assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) . The Oral Mucositis Weekly Questionnaire-Head and Neck Cancer will be used to describe the short-term effects of radiation on QOL during treatment. Scores will be assessed by comparing the within-patient change. The treatment effect will be estimated with a generalized linear mixed model, describing the continuous EORTC quality of life outcomes as a function of a random patient effect, and fixed effects for treatment assignment, time, the stratification factor, the treatment assignment and the treatment/time interaction. The magnitude, direction and 95% confidence interval for the adjusted interaction term estimate will be used to describe the effect of olanzapine in improving different QOL domains. An interaction p-value \< 0.05 will be considered statistically significant.
Change in Quality of Life
Will be assessed using the EORTC QLQ-H\&N43 module questionnaire. Mean change from
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