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Confirm low-dose olanzapine for appetite and weight in advanced cancer worldwide

An Indian trial found a cheap antipsychotic pill in very low dose improved appetite and weight gain in patients with advanced stomach, lung and pancreatic cancer. It needs confirming and adopting worldwide.

A randomised placebo-controlled trial from Tata Memorial (published in the Journal of Clinical Oncology, 2023) found that 2.5 mg olanzapine daily improved weight gain and appetite in chemotherapy-naive patients with advanced gastric, lung and hepatopancreatobiliary cancers, an area where expensive investigational agents have repeatedly failed. Olanzapine costs cents and is already used for chemotherapy-induced nausea. The proposal is a multinational confirmatory trial with weight, appetite, quality of life and survival endpoints, coupled with a guideline and label strategy so the result reaches patients.

Hypothesis
Low-dose olanzapine increases the proportion of patients with advanced cancer gaining more than 5% body weight at 12 weeks by at least 20 absolute percentage points versus placebo, with improved appetite scores and no excess sedation.
Rationale
The initial trial effect was large and the drug's safety at 2.5 mg is well established; cachexia has no approved effective drug in most countries, and a generic solution would be adopted immediately if confirmed.
What would test it
Randomised placebo-controlled trial of about 500 patients across three continents with weight gain primary endpoint, followed by ESMO and ASCO guideline submissions.
Maturity
early clinical
Who has to act
research
Cost to try
Medium ($1M to $50M)
Years to first evidence
3
Bottlenecks it attacks

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