Birmingham, AL—Nausea and vomiting, even if unrelated to chemotherapy, often torment patients dealing with advanced cancer.

A new study published in JAMA Oncology suggests an effective—and relatively inexpensive—remedy. University of Alabama at Birmingham–led authors suggest that olanzapine, a generic drug used to treat nervous, emotional, and mental conditions, appears to beneficial in helping patients with advanced cancer successfully manage those digestive issue.

“It’s well-appreciated by most people that patients receiving cancer chemotherapy suffer from nausea and vomiting,” explained coauthor Charles Loprinzi, MD, of the Mayo Clinic. “However, it’s less well-appreciated that patients with advanced cancer also have significant problems with nausea and vomiting that are unrelated to chemotherapy.”

Researchers were aware of case reports, small retrospectively evaluated series and a prospective pilot exploration supporting that olanzapine might be effective for the relief of nausea/vomiting, unrelated to chemotherapy, in patients with advanced cancer.

“On that basis, it was hypothesized that olanzapine would be an effective treatment of chronic nausea/vomiting in patients with advanced cancer, leading to the conduct of the currently reported trial,” according to the authors.

Because research has been limited on nausea and vomiting unrelated to chemotherapy, the study team decided to conduct a randomized, placebo-controlled clinical trial in 30 patients with advanced cancer who had not recently received chemotherapy or radiation therapy—in the last 14 days—but did have substantial trouble with nausea and vomiting.

Conducted from July 2017 through April 2019, with analysis conducted in 2019, the study focused on patients for whom chronic nausea was present for at least a week and was rated greater than 3 on a 0-10 scale. Participants received olanzapine (5 mg) or a placebo, orally, daily for 7 days.

Researchers used patient-reported outcomes for study end points, with data collected at baseline and daily for 7 more days. The primary study end point was defined as the change in nausea numeric rating scores from baseline to the last treatment day.

The 16 women and 14 men who participated had a mean age of 63 and baseline median nausea scores of 9 out of 10 (range, 8-10).

Results indicate that after 1 day and 1 week, the median nausea scores in the placebo arm were 9 out of 10 (range, 8-10) on both days, compared with the olanzapine arm scores of 2 out of 10 (range, 2-3) after day one and 1 out of 10 (range, 0-3) after a week.

“After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm,” the authors write. “The primary 2-sided end point P value was <.001. Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being.”

Only one patient, who was taking the placebo, stopped treatment early owing to lack of perceived benefit. No patients receiving olanzapine reported excess sedation or any other adverse event, according to the study.

Researchers conclude that olanzapine, at 5 mg/d, appeared to be effective in controlling nausea and emesis and in improving other symptoms and quality-of-life parameters in the study population.

“Olanzapine given at 5 milligrams per day for seven days markedly improved patient quality of life with no side effects,” emphasized lead author Rudolph M. Navari, MD. “And as a generic drug, it’s also relatively affordable, with a one-month supply often costing anywhere from $10 to $15.”

“Current guidelines for the management of nausea and vomiting in patients with advanced cancer have not specifically indicated that one drug looks substantially better than a variety of other drugs,” Dr. Loprinzi added. “However, we believe the present results may be viewed as a best practice for treating nausea and vomiting in patients with advanced cancer-associated nausea and vomiting.”

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